Trial no.:	PACTR202407771418605	Date of Registration:	26/07/2024
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

CVIA 106 - Phase 2/3 study of the EuBiologics pentavalent meningococcal ACWYX conjugate vaccine compared to MENVEO® or Nimenrix ® in healthy children through adults

Official scientific title

A Phase 2/3 observer-blind, randomized, active-controlled study of the EuBiologics pentavalent meningococcal ACWYX conjugate vaccine (EuNmCV-5 Multi-dose) in healthy infants, toddlers, children, adolescents, and adults, to examine its safety, immunogenicity (including lot-to-lot consistency), and immunological non-inferiority when compared to MENVEO® or Nimenrix® as well as its non-interference with routinely co-administered vaccines

Brief summary describing the background and objectives of the trial

Based on the promising safety and immunogenicity results from the Phase 1 study in Korean adults (EuVCT_MCV102, NCT05739292), this Phase 2/3 two-site clinical study in West Africa will include a progressive step-wise evaluation of the safety and immunogenicity profile of EuNmCV-5, covering the age range of 9 months to 29 years of age. This study will include a lot-to-lot comparison and an assessment of co administration with measles-rubella (MR) and yellow fever (YF) vaccines, as these are routinely administered within the EPI in this setting. Taken together, both studies should provide sufficient clinical data for marketing authorization and WHO prequalification of the vaccine for use in campaigns in individuals ≥ 1 and ≤ 29 years of age and in routine immunization programs at ≥ 9 months of age across the African meningitis belt.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Nervous System Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Prevention: Vaccines

Anticipated trial start date

20/08/2024

Actual trial start date

Anticipated date of last follow up

29/05/2026

Actual Last follow-up date

Anticipated target sample size (number of participants)

4236

Actual target sample size (number of participants)

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register
CVIA 106	Sponsor

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Permuted block randomization	Allocation was determined by the holder of the sequence who is situated off site	Masking/blinding used	Care giver/Provider,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	EuNmCV5	2.5 mL/5 dose, 0.5 mL/dose	22 months	Pentavalent meningococcal conjugate vaccine containing serogroups A, C, W, Y, and X (10 µg of A; 5 µg of C, W, Y, and X) conjugated to recombinant diphtheria toxin variant CRM197 and 2-PE in a multi-dose (2.5 mL/5 dose, 0.5 mL/dose) vial administered intramuscularly (IM)	2970
Control Group	MENVEO	0.5 mL	22 months	Quadrivalent meningococcal conjugate vaccine containing serogroups A, C, W, and Y conjugated to a modified diphtheria toxin (MenACWY-CRM) in a single-dose of 0.5 mL administered IM	846	Dose Comparison
Control Group	Nimenrix	0.5mL	22 months	Quadrivalent meningococcal conjugate vaccine containing serogroups A, C, W, and Y conjugated to TT (MenACWY TT) in a single-dose of 0.5 mL administered IM	420	Dose Comparison

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1.Male or female participants with the age at time of study vaccination 2.Participant informed consent or assent and/or parent and/or legal guardian informed consent: a.Children ≤ 17 years of age: Signed or fingerprinted or personally marked written informed consent obtained from parent and/or legal guardian b.Children ≥ 12 years of age in The Gambia and ≥ 13 years of age in Mali: Participant signed or fingerprinted or personally marked written informed assent c.Adults ≥ 18 years of age: Signed or fingerprinted or personally marked written informed consent Note: Participants who turn 18 years of age during the study period, will be required to provide informed consent 3.Children who complete their local EPI schedule: a.A birth dose of OPV is not required b.Cohort 2: Through and including 9 months of age (no MenAfriVac® dose) c.Cohort 4: Through and prior to 15 months of age (no MenAfriVac® dose and no 15+ months EPIs) d.Cohort 5: Through and prior to 9 months of age (no MenAfriVac® dose and no 9+ months EPIs) 4.Healthy, as defined by the absence of any clinically significant medical conditions 5.Participant and/or parent and/or legal guardian of the participant resides in the study site area, with no intent to move out during the study period, and is able and willing to adhere to all protocol requirements 6.Participant must be either of non-childbearing potential or, if of childbearing potential, not breastfeeding and not pregnant and must have been practicing adequate contraception for ≥ 2 months prior to study vaccination and agree to continue such precautions consistently through 2 months post study vaccination, as well as agree to not become pregnant through other means 7.Participant agrees not to enroll in another study of an investigational research agent	1.Acute illness at the time of study vaccination 2.Recorded fever/use of an antipyretic medication within 48 hours prior to study vaccination 3.Cohorts 1 and 2: a. Abnormal safety laboratory test value for age b. Laboratory confirmed HIV, chronic hepatitis B virus infection, and/or hepatitis C virus infection 4.Current/previous N. meningitidis 5.Household contact/intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 90 days prior to Screening 6.Administration of systemic antibiotic treatment within 3 days of study vaccination 7.Administration of any vaccine other than the study vaccines within 28 days prior to/after study vaccination 8. Participation in another investigational product clinical study within 90 days prior to enrollment in this study/receipt of any such investigational product other than the study vaccines within 30 days prior to administration of study vaccines/planned use during study 9.Receipt of immunoglobulins and/or any blood products within 90 days prior to study vaccination/planned administration during study 10.Confirmed/suspected/family history immunodeficiency of congenital or hereditary immunodeficiency 11.Prior use of or anticipated need of long-acting immunomodulating drug/chronic administration of high dose systemic corticosteroids during study 12.History of severe adverse/allergic reaction to any vaccine or any components of the study vaccines 13.Participant is an employee/close personal relation of any person employed by the Sponsor, PATH, the CRO, the PI, key study site personnel 14.Planned surgery during the study period that would require hospitalization, use of prohibited medication, or will interfere with follow-up visits 15.History of known disturbance of coagulation/blood disorder 16.Medical/psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 17.Neurological disease/disorder	Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year	9 Month(s)	29 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

13/06/2024

The Gambia Government MRC Joint Ethics Committee

Ethics Committee Address
Street address	City	Postal code	Country
MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia	Banjul	NA	Gambia

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

20/05/2024

Ethics Committee EC of the Faculte de Medecine de Pharmacie et dOdonto Stomatologie FMPOS of the University of Science Technics and Technologies of Bamako

Ethics Committee Address
Street address	City	Postal code	Country
Faculte de Medecine, de Pharmacie et deOdonto-Stomatologie Point G	Bamako	1805	Mali

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169).	Day 8 post-vaccination, Day 29, post-vaccination Day 169 post-vaccination
Secondary Outcome	Cohort 1 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineA and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 post-vaccination if the rSBA titer at Baseline was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at Baseline and 28 days post-vaccination	Day 29 post-vaccination
Primary Outcome	Cohort 2 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 336 days post-vaccination	Day 8 post-vaccination, Day 29 post-vaccination, Day 337 post-vaccination
Secondary Outcome	Cohort 2 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 following study vaccination if the rSBA titer at BaselineB was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB , and at 168 and 336 days post-vaccination (Days 169 and 337, respectively). 2.Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination (Days 169 and 337, respectively).	Day 29 post-vaccination
Primary Outcome	Cohort 3 1. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination	Day 29 post-vaccination
Secondary Outcome	Cohort 3 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of children and adolescents ≥ 2 to ≤ 17 years of age 5. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 6. Percentage of participants with seroresponse, measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 8. In a subset of participants ≥ 2 and ≤ 29 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and at 168 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, against serogroups A, C, W, Y, and X at at BaselineB and at 168 days post-vaccination 9. In a subset of children and adolescents ≥ 2 and ≤ 17 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128 against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination	Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 169, Day 337 - All time points mentioned post-vaccination
Primary Outcome	Cohort 4 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination	Day 29 post-vaccination
Secondary Outcome	Cohort 4 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days post-vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days post-vaccination (Day 169) in a subset of participants. 2. Percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days post-vaccination (Day 169) in a subset of participants.	Day 8, Day 29 , Day 29, Day 29, Day 29, Day 29, Day 29 - All time points mentioned post-vaccination
Primary Outcome	Cohort 5 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination	Day 29 post-vaccination
Secondary Outcome	Cohort 5 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of participants 5. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 6. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 7. Percentage of participants with seroprotective titers for YF vaccine at 28 days post-vaccination. The seroprotective response to YF vaccine is defined as YF virus neutralizing antibody titers measured by PRNT50 ≥ 1:10. 8. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 9. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 10. In a subset of participants, GMTs of rSBA against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination. 11. In a subset of participants, percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination.	Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 29, Day 29, Day 169 and Day 337, Day 169 and Day 137 - All time points post-vaccination
Primary Outcome	Cohort 6 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination	Day 8 post-vaccination, Day 29 post-vaccination, Day 169 post-vaccination
Primary Outcome	Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169).	Day 8 post-vaccination, Day 29, post-vaccination Day 169 post-vaccination
Secondary Outcome	Cohort 1 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineA and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 post-vaccination if the rSBA titer at Baseline was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at Baseline and 28 days post-vaccination	Day 29 post-vaccination
Primary Outcome	Cohort 2 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 336 days post-vaccination	Day 8 post-vaccination, Day 29 post-vaccination, Day 337 post-vaccination
Secondary Outcome	Cohort 2 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 following study vaccination if the rSBA titer at BaselineB was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB , and at 168 and 336 days post-vaccination (Days 169 and 337, respectively). 2.Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination (Days 169 and 337, respectively).	Day 29 post-vaccination
Primary Outcome	Cohort 3 1. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination	Day 29 post-vaccination
Secondary Outcome	Cohort 3 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of children and adolescents ≥ 2 to ≤ 17 years of age 5. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 6. Percentage of participants with seroresponse, measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 8. In a subset of participants ≥ 2 and ≤ 29 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and at 168 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, against serogroups A, C, W, Y, and X at at BaselineB and at 168 days post-vaccination 9. In a subset of children and adolescents ≥ 2 and ≤ 17 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128 against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination	Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 169, Day 337 - All time points mentioned post-vaccination
Primary Outcome	Cohort 4 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination	Day 29 post-vaccination
Secondary Outcome	Cohort 4 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days post-vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days post-vaccination (Day 169) in a subset of participants. 2. Percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days post-vaccination (Day 169) in a subset of participants.	Day 8, Day 29 , Day 29, Day 29, Day 29, Day 29, Day 29 - All time points mentioned post-vaccination
Primary Outcome	Cohort 5 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination	Day 29 post-vaccination
Secondary Outcome	Cohort 5 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of participants 5. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 6. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 7. Percentage of participants with seroprotective titers for YF vaccine at 28 days post-vaccination. The seroprotective response to YF vaccine is defined as YF virus neutralizing antibody titers measured by PRNT50 ≥ 1:10. 8. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 9. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 10. In a subset of participants, GMTs of rSBA against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination. 11. In a subset of participants, percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination.	Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 29, Day 29, Day 169 and Day 337, Day 169 and Day 137 - All time points post-vaccination
Primary Outcome	Cohort 6 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination	Day 8 post-vaccination, Day 29 post-vaccination, Day 169 post-vaccination

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine	Atlantic Boulevard Fajara	Banjul		Gambia
Center for Vaccine Development Mali CVD Mali	Ex-Institut Marchoux Avenue Mohamed VI Djicoroni Para	Bamako	251	Mali

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Bill and Melinda Gates Foundation	500 5th Avenue North	Seattle	98109	United States of America
Research Investment for Global Health Technology Foundation	International Vaccine Institute, 2nd Floor, SNU, Research Park, 1 Gwanak-ro, Gwanak-gu	Seoul	08826	Korea, Republic of
Eubiologics Co Ltd	8F Seongdo B/D, 207 Dosan-daero, Sinsa-dong, Gangnma-gu	Seoul	06026	Korea, Republic of

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Eubiologics Co Ltd	8F Seongdo B/D, 207 Dosan-daero, Sinsa-dong, Gangnma-gu	Seoul	06026	Korea, Republic of	Commercial Sector/Industry

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Scientific Enquiries	Christina Polyak	cpolyak@path.org	+12064738079	PATHs Center for Vaccine Innovation and Access 455 Massachusetts Ave Suite 1100
City	Postal code	Country	Position/Affiliation
Washington	20001	United States of America	Medical Officer
Role	Name	Email	Phone	Street address
Public Enquiries	Niles Eaton	neaton@path.org	+12066963576	PATH Center for Vaccine Innovation and Access 2201 Westlake Avenue Suite 200
City	Postal code	Country	Position/Affiliation
Seattle	WA 98121	United States of America	Clinical Research Manager
Role	Name	Email	Phone	Street address
Principal Investigator	Ed Clarke	ed.clarke@lshtm.ac.uk	+2207039732	Medical Research Council MRC Unit The Gambia at London School of Hygiene and Tropical Medicine
City	Postal code	Country	Position/Affiliation
Fajara		Gambia	Principal Investigator
Role	Name	Email	Phone	Street address
Principal Investigator	Samba Sow	ssow@cvd-mali.org	+2232236031	Centre pour le Developpement des Vaccins du Mali CNAM Ex Institut Marchoux, Ministere de la Sante et de lHygiene Publique
City	Postal code	Country	Position/Affiliation
Bamako		Mali	Principal Investigator

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Data obtained through this study may be provided to qualified researchers with academic interest in Meningococcal disease. The individual participant data (IPD) that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.	Study Protocol	Beginning 3 months and ending 3 years following article publication.	Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact EuBiologics.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Recruitment status	26/08/2025	Trial is currently enrolling	Not yet recruiting	Recruiting
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	01/11/2025	The timepoints were previously numbered in correspondence to the outcomes. However, commas have now been inserted for ease of reference.	Primary Outcome, Cohort 1 1. Number and severity of solicited AEs for 7 days following study vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination (Day 169). , 1. Day 8 2. Day 29 3. Day 169	Primary Outcome, Cohort 1 1. Number and severity of solicited AEs for 7 days following study vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination (Day 169). , Day 8, Day 29, Day 169
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcome clarified	Primary Outcome, Cohort 1 1. Number and severity of solicited AEs for 7 days following study vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination (Day 169). , Day 8, Day 29, Day 169	Primary Outcome, Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169). , Day 8, Day 29, Day 169
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcome clarified	Primary Outcome, Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169). , Day 8, Day 29, Day 169	Primary Outcome, Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169). , Day 8, Day 29, Day 169 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcome clarified	Primary Outcome, Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169). , Day 8, Day 29, Day 169 post-vaccination	Primary Outcome, Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169). , Day 8 post-vaccination, Day 29, post-vaccination Day 169 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcome clarified	Secondary Outcome, Cohort 1 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineA and 28 days following study vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 following study vaccination if the rSBA titer at Baseline was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at Baseline and 28 days following study vaccination , Day 29	Secondary Outcome, Cohort 1 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineA and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 post-vaccination if the rSBA titer at Baseline was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at Baseline and 28 days post-vaccination , Day 29
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcome clarified	Secondary Outcome, Cohort 1 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineA and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 post-vaccination if the rSBA titer at Baseline was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at Baseline and 28 days post-vaccination , Day 29	Secondary Outcome, Cohort 1 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineA and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 post-vaccination if the rSBA titer at Baseline was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at Baseline and 28 days post-vaccination , Day 29 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	01/11/2025	The timepoints were previously numbered in correspondence to the outcomes. However, commas have now been inserted for ease of reference.	Primary Outcome, Cohort 2 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 336 days following study vaccination , 1. Day 8 2. Day 29 3. Day 337	Primary Outcome, Cohort 2 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 336 days following study vaccination , Day 8, Day 29, Day 337
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcomes clarified	Primary Outcome, Cohort 2 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 336 days following study vaccination , Day 8, Day 29, Day 337	Primary Outcome, Cohort 2 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 336 days post-vaccination , Day 8, Day 29, Day 337
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Primary Outcome, Cohort 2 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 336 days post-vaccination , Day 8, Day 29, Day 337	Primary Outcome, Cohort 2 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 336 days post-vaccination , Day 8 post-vaccination, Day 29 post-vaccination, Day 337 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcomes clarified	Secondary Outcome, Cohort 2 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 following study vaccination if the rSBA titer at BaselineB was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB , and at 168 and 336 days following study vaccination (Days 169 and 337, respectively). 2.Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days following study vaccination (Days 169 and 337, respectively)., Day 29	Secondary Outcome, Cohort 2 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 following study vaccination if the rSBA titer at BaselineB was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB , and at 168 and 336 days post-vaccination (Days 169 and 337, respectively). 2.Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination (Days 169 and 337, respectively)., Day 29
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Secondary Outcome, Cohort 2 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 following study vaccination if the rSBA titer at BaselineB was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB , and at 168 and 336 days post-vaccination (Days 169 and 337, respectively). 2.Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination (Days 169 and 337, respectively)., Day 29	Secondary Outcome, Cohort 2 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. (Seroresponse is defined as a rSBA titer ≥ 1:32 following study vaccination if the rSBA titer at BaselineB was < 1:8; or a ≥ 4-fold increase over Baseline if the Baseline rSBA titer was ≥ 1:8.) 3. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB , and at 168 and 336 days post-vaccination (Days 169 and 337, respectively). 2.Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination (Days 169 and 337, respectively)., Day 29 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcomes clarified	Primary Outcome, Cohort 3 1. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination , Day 29	Primary Outcome, Cohort 3 1. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Primary Outcome, Cohort 3 1. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29	Primary Outcome, Cohort 3 1. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	03/11/2025	The timepoints were previously numbered in correspondence to the outcomes. However, commas have now been inserted for ease of reference.	Secondary Outcome, Cohort 3 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Number, severity, and relatedness of SAEs for 336 days following study vaccination in a subset of children and adolescents ≥ 2 to ≤ 17 years of age 5. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination 6. Percentage of participants with seroresponse, measured by rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination 8. In a subset of participants ≥ 2 and ≤ 29 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and at 168 days following study vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, against serogroups A, C, W, Y, and X at at BaselineB and at 168 days following study vaccination 9. In a subset of children and adolescents ≥ 2 and ≤ 17 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at at BaselineB and at 336 days following study vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128 against serogroups A, C, W, Y, and X at at BaselineB and at 336 days following study vaccination , 1. Day 8 2. Day 29 3. Day 169 4. Day 337 5. Day 29 6. Day 29 7. Day 29 8. Day 169 9. Day 337	Secondary Outcome, Cohort 3 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Number, severity, and relatedness of SAEs for 336 days following study vaccination in a subset of children and adolescents ≥ 2 to ≤ 17 years of age 5. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination 6. Percentage of participants with seroresponse, measured by rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination 8. In a subset of participants ≥ 2 and ≤ 29 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and at 168 days following study vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, against serogroups A, C, W, Y, and X at at BaselineB and at 168 days following study vaccination 9. In a subset of children and adolescents ≥ 2 and ≤ 17 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at at BaselineB and at 336 days following study vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128 against serogroups A, C, W, Y, and X at at BaselineB and at 336 days following study vaccination , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 169, Day 337
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcomes clarified	Secondary Outcome, Cohort 3 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Number, severity, and relatedness of SAEs for 336 days following study vaccination in a subset of children and adolescents ≥ 2 to ≤ 17 years of age 5. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination 6. Percentage of participants with seroresponse, measured by rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination 8. In a subset of participants ≥ 2 and ≤ 29 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and at 168 days following study vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, against serogroups A, C, W, Y, and X at at BaselineB and at 168 days following study vaccination 9. In a subset of children and adolescents ≥ 2 and ≤ 17 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at at BaselineB and at 336 days following study vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128 against serogroups A, C, W, Y, and X at at BaselineB and at 336 days following study vaccination , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 169, Day 337	Secondary Outcome, Cohort 3 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of children and adolescents ≥ 2 to ≤ 17 years of age 5. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 6. Percentage of participants with seroresponse, measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 8. In a subset of participants ≥ 2 and ≤ 29 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and at 168 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, against serogroups A, C, W, Y, and X at at BaselineB and at 168 days post-vaccination 9. In a subset of children and adolescents ≥ 2 and ≤ 17 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128 against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 169, Day 337
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Secondary Outcome, Cohort 3 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of children and adolescents ≥ 2 to ≤ 17 years of age 5. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 6. Percentage of participants with seroresponse, measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 8. In a subset of participants ≥ 2 and ≤ 29 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and at 168 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, against serogroups A, C, W, Y, and X at at BaselineB and at 168 days post-vaccination 9. In a subset of children and adolescents ≥ 2 and ≤ 17 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128 against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 169, Day 337	Secondary Outcome, Cohort 3 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of children and adolescents ≥ 2 to ≤ 17 years of age 5. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 6. Percentage of participants with seroresponse, measured by rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination 8. In a subset of participants ≥ 2 and ≤ 29 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and at 168 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, against serogroups A, C, W, Y, and X at at BaselineB and at 168 days post-vaccination 9. In a subset of children and adolescents ≥ 2 and ≤ 17 years of age: o GMTs of rSBA against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination o Percentages of participants with rSBA titer of ≥ 1:8 and ≥ 1:128 against serogroups A, C, W, Y, and X at at BaselineB and at 336 days post-vaccination , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 169, Day 337 - All time points mentioned post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcome clarified	Primary Outcome, Cohort 4 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days following study vaccination , Day 29	Primary Outcome, Cohort 4 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcome clarified	Primary Outcome, Cohort 4 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29	Primary Outcome, Cohort 4 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	03/11/2025	The timepoints were previously numbered in correspondence to the outcomes. However, commas have now been inserted for ease of reference.	Secondary Outcome, Cohort 4 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Percentage of participants with seropositive response for measles at 28 days following study vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days following study vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days following study vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days following study vaccination (Day 169) in a subset of participants. 2.Percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days following study vaccination (Day 169) in a subset of participants. , 1. Day 8 2. Day 29 3. Day 29 4. Day 29 5. Day 29 6. Day 29 7. Day 29	Secondary Outcome, Cohort 4 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Percentage of participants with seropositive response for measles at 28 days following study vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days following study vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days following study vaccination. Persistence outcomes , Day 8, Day 29, Day 29, Day 29, Day 29, Day 29, Day 29
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcomes clarified	Secondary Outcome, Cohort 4 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Percentage of participants with seropositive response for measles at 28 days following study vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days following study vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days following study vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days following study vaccination. Persistence outcomes , Day 8, Day 29, Day 29, Day 29, Day 29, Day 29, Day 29	Secondary Outcome, Cohort 4 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days post-vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days post-vaccination (Day 169) in a subset of participants. 2. Percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days post-vaccination (Day 169) in a subset of participants. , Day 8, Day 29, Day 29, Day 29, Day 29, Day 29, Day 29
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Secondary Outcome, Cohort 4 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days post-vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days post-vaccination (Day 169) in a subset of participants. 2. Percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days post-vaccination (Day 169) in a subset of participants. , Day 8, Day 29, Day 29, Day 29, Day 29, Day 29, Day 29	Secondary Outcome, Cohort 4 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days post-vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days post-vaccination (Day 169) in a subset of participants. 2. Percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days post-vaccination (Day 169) in a subset of participants. , Day 8, Day 29 , Day 29, Day 29, Day 29, Day 29, Day 29 - All time points post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Secondary Outcome, Cohort 4 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days post-vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days post-vaccination (Day 169) in a subset of participants. 2. Percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days post-vaccination (Day 169) in a subset of participants. , Day 8, Day 29 , Day 29, Day 29, Day 29, Day 29, Day 29 - All time points post-vaccination	Secondary Outcome, Cohort 4 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. 7. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days post-vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days post-vaccination (Day 169) in a subset of participants. 2. Percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days post-vaccination (Day 169) in a subset of participants. , Day 8, Day 29 , Day 29, Day 29, Day 29, Day 29, Day 29 - All time points mentioned post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcomes clarified	Primary Outcome, Cohort 5 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days following study vaccination , Day 29	Primary Outcome, Cohort 5 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Primary Outcome, Cohort 5 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29	Primary Outcome, Cohort 5 1. The percentage of participants with rSBA titers ≥ 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination , Day 29 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	03/11/2025	The timepoints were previously numbered in correspondence to the outcomes. However, commas have now been inserted for ease of reference.	Secondary Outcome, Cohort 5 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Number, severity, and relatedness of SAEs for 336 days following study vaccination in a subset of participants 5. Percentage of participants with seropositive response for measles at 28 days following study vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 6. Percentage of participants with seropositive response for rubella at 28 days following study vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 7. Percentage of participants with seroprotective titers for YF vaccine at 28 days following study vaccination. The seroprotective response to YF vaccine is defined as YF virus neutralizing antibody titers measured by PRNT50 ≥ 1:10. 8. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination. 9. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination. 10. In a subset of participants, GMTs of rSBA against serogroups A, C, W, Y, and X at 168 and 336 days following study vaccination. 11. In a subset of participants, percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days following study vaccination. , 1. Day 8 2. Day 29 3. Day 169 4. Day 337 5. Day 29 6. Day 29 7. Day 29 8. Day 29 9. Day 29 10. Day 169 and Day 337 11. Day 169 and Day 137	Secondary Outcome, Cohort 5 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Number, severity, and relatedness of SAEs for 336 days following study vaccination in a subset of participants 5. Percentage of participants with seropositive response for measles at 28 days following study vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 6. Percentage of participants with seropositive response for rubella at 28 days following study vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 7. Percentage of participants with seroprotective titers for YF vaccine at 28 days following study vaccination. The seroprotective response to YF vaccine is defined as YF virus neutralizing antibody titers measured by PRNT50 ≥ 1:10. 8. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination. 9. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination. 10. In a subset of participants, GMTs of rSBA against serogroups A, C, W, Y, and X at 168 and 336 days following study vaccination. 11. In a subset of participants, percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days following study vaccination. , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 29, Day 29, Day 169 and Day 337, Day 169 and Day 137
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcomes clarified	Secondary Outcome, Cohort 5 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination 4. Number, severity, and relatedness of SAEs for 336 days following study vaccination in a subset of participants 5. Percentage of participants with seropositive response for measles at 28 days following study vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 6. Percentage of participants with seropositive response for rubella at 28 days following study vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 7. Percentage of participants with seroprotective titers for YF vaccine at 28 days following study vaccination. The seroprotective response to YF vaccine is defined as YF virus neutralizing antibody titers measured by PRNT50 ≥ 1:10. 8. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination. 9. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days following study vaccination. 10. In a subset of participants, GMTs of rSBA against serogroups A, C, W, Y, and X at 168 and 336 days following study vaccination. 11. In a subset of participants, percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days following study vaccination. , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 29, Day 29, Day 169 and Day 337, Day 169 and Day 137	Secondary Outcome, Cohort 5 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of participants 5. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 6. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 7. Percentage of participants with seroprotective titers for YF vaccine at 28 days post-vaccination. The seroprotective response to YF vaccine is defined as YF virus neutralizing antibody titers measured by PRNT50 ≥ 1:10. 8. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 9. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 10. In a subset of participants, GMTs of rSBA against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination. 11. In a subset of participants, percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination. , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 29, Day 29, Day 169 and Day 337, Day 169 and Day 137
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Secondary Outcome, Cohort 5 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of participants 5. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 6. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 7. Percentage of participants with seroprotective titers for YF vaccine at 28 days post-vaccination. The seroprotective response to YF vaccine is defined as YF virus neutralizing antibody titers measured by PRNT50 ≥ 1:10. 8. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 9. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 10. In a subset of participants, GMTs of rSBA against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination. 11. In a subset of participants, percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination. , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 29, Day 29, Day 169 and Day 337, Day 169 and Day 137	Secondary Outcome, Cohort 5 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Number, severity, and relatedness of SAEs for 336 days post-vaccination in a subset of participants 5. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration ≥ 200 mIU/mL. 6. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as ≥ 10 IU/mL. 7. Percentage of participants with seroprotective titers for YF vaccine at 28 days post-vaccination. The seroprotective response to YF vaccine is defined as YF virus neutralizing antibody titers measured by PRNT50 ≥ 1:10. 8. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 9. Percentage of participants with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at BaselineB and 28 days post-vaccination. 10. In a subset of participants, GMTs of rSBA against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination. 11. In a subset of participants, percentage with rSBA titer of ≥ 1:8 and ≥ 1:128, respectively, against serogroups A, C, W, Y, and X at 168 and 336 days post-vaccination. , Day 8, Day 29, Day 169, Day 337, Day 29, Day 29, Day 29, Day 29, Day 29, Day 169 and Day 337, Day 169 and Day 137 - All time points post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	03/11/2025	The timepoints were previously numbered in correspondence to the outcomes. However, commas have now been inserted for ease of reference.	Primary Outcome, Cohort 6 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination , 1. Day 8 2. Day 29 3. Day 169	Primary Outcome, Cohort 6 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination , Day 8, Day 29, Day 169
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/11/2025	Outcomes clarified	Primary Outcome, Cohort 6 1. Number and severity of solicited AEs for 7 days following study vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days following study vaccination 3. Number, severity, and relatedness of SAEs for 168 days following study vaccination , Day 8, Day 29, Day 169	Primary Outcome, Cohort 6 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination , Day 8, Day 29, Day 169
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	26/11/2025	Outcomes clarified	Primary Outcome, Cohort 6 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination , Day 8, Day 29, Day 169	Primary Outcome, Cohort 6 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination , Day 8 post-vaccination, Day 29 post-vaccination, Day 169 post-vaccination
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	08/07/2024	Updated with Ethics approval date and letter	FALSE, The Gambia Government MRC Joint Ethics Committee, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia, Banjul, NA, Gambia, 01 May 2024, , +2204495442, ethics@mrc.gm,	TRUE, The Gambia Government MRC Joint Ethics Committee, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia, Banjul, NA, Gambia, 01 May 2024, 13 Jun 2024, +2204495442, ethics@mrc.gm, 29414_29442_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	08/07/2024	Updated with Ethics approval date and letter	FALSE, Ethics Committee EC of the Faculte de Medecine de Pharmacie et dOdonto Stomatologie FMPOS of the University of Science Technics and Technologies of Bamako, Faculte de Medecine, de Pharmacie et deOdonto-Stomatologie Point G, Bamako, 1805, Mali, 30 Apr 2024, , 0022366231191, mdiakite@icermali.org,	TRUE, Ethics Committee EC of the Faculte de Medecine de Pharmacie et dOdonto Stomatologie FMPOS of the University of Science Technics and Technologies of Bamako, Faculte de Medecine, de Pharmacie et deOdonto-Stomatologie Point G, Bamako, 1805, Mali, 30 Apr 2024, 20 May 2024, 0022366231191, mdiakite@icermali.org, 29414_29456_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	22/07/2024	Updated IPD Description	The results of the trial will be shared with trial participants in a manner clearly stipulated by the protocol team. The Study Report will also be made available in line with the country, international and sponsor regulations.	Data obtained through this study may be provided to qualified researchers with academic interest in Meningococcal disease. The individual participant data (IPD) that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD-Sharing time frame	22/07/2024	Updated IPD-Sharing Time Frame	3 years	Beginning 3 months and ending 3 years following article publication.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Key access criteria	22/07/2024	Updated Key Access Criteria	Final Study Report from protocol team	Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact EuBiologics.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Study protocol document	22/07/2024	Updated Additional Document Types	Clinical Study Report	Study Protocol

Pan African Clinical Trials Registry