Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201908558841221 Date of Approval: 19/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)
Official scientific title A phase 3, observer-blind, randomized, active controlled trial to assess the safety of an investigational meningococcal serogroups ACYWX conjugate vaccine (NmCV-5) and compare its immunogenicity to a licensed meningococcal serogroups ACYW conjugate vaccine (Menactra®), in healthy subjects 2 to 29 years of age.
Brief summary describing the background and objectives of the trial This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra. A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years & 2-10 years (400 NmCV-5 recipients & 200 Menactra recipients in each age strata). Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA). Trial Objectives: a) To demonstrate that the immune responses to NmCV-5 are noninferior to those elicited by Menactra®. b) To assess the safety and tolerability of a single dose of NmCV-5 or Menactra®
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Meningococcal Meningitis
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 06/08/2019
Actual trial start date
Anticipated date of last follow up 21/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 1800
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
ACYWX3 CVIA071 Serum Institute of India Pvt. Ltd.
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Polyvalent conjugated Meningococcal vaccine NmCV5 Subjects in this arm will receive polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. A single dose of 0.5 mL will be administered intramuscularly. Single dose Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to Cross Reactive Material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. 1200
Control Group Menactra A single dose of 0.5 mL will be administered intramuscularly. Single Dose Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&W X conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. 600 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration. 2. Written informed consent obtained from subjects at least 18 years of age or from their parent/guardian for subjects less than 18 years of age with additional subject assent obtained as appropriate for participating community (i.e. subjects at least 13 years of age in Mali or at least 12 years of age in The Gambia). 3. Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures. 4. Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study IP administration and agree to continue adequate contraception until completion of their Day 29 visit. 5. Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration 1. Acute illness, at the time of study IP administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility). 2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study IP administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility). 3. Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years. 4. Current or previous, confirmed disease caused by Neisseria meningitidis. 5. Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration. 6. Known hypersensitivity to any component of the study IPs (i.e., NmCV-5 or Menactra®). 7. History of significant hypersensitivity reactions to any previous vaccine. 8. Administration of any vaccine other than study IPs within 28 days prior to study IP administration or planned administration prior to completion of the study Day 29 visit. 9. Administration of any investigational drug within 30 days prior to study IP administration or planned administration during the study period. 10. Unwilling to avoid (or their child to avoid, if the subject) the ingestion of herbal or other traditional medications during the study period. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(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 30/01/2019 The Gambia Government MRCG Joint ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
MRC Unit, The Gambia at LSHTM, Fajara P.O. Box 273, Banjul The Gambia, West Africa Banjul 339331 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 25/02/2019 Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine of Pharmacy and Odontostomatology, Point G, Bamako Bamako 1805 Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Outcome Measure: 1. Seroresponse Percentage of subjects with seroresponse, measured by rabbit complement serum bactericidal activity (rSBA) against serogroups A, C, Y, W and X. [Seroresponse is defined as a post-immunization (Day 29) rSBA titer of 32 or greater if the subject’s pre-immunization (Day 1) rSBA titer was < 8; or a ≥ four-fold increase over baseline at Day 29 postimmunization if the subject’s pre-immunization (Day 1) rSBA titer was ≥ 8]. 2. Geometric mean titres Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X on Day 29 At baseline prior to vaccination - Day 1 and 28 days post vaccination - Day 29
Secondary Outcome 1. Solicited adverse events Solicited AEs for 7 days following vaccination 7 days post vaccination
Secondary Outcome 2. Unsolicited adverse events Unsolicited AEs for 28 days following vaccination 28 days post vaccination
Secondary Outcome 3. Solicited adverse events Solicited AEs for 7 days following vaccination 7 days post vaccination 7 days post vaccination
Secondary Outcome 4. Unsolicited adverse events Unsolicited AEs for 28 days following vaccination 28 Days post vaccination
Secondary Outcome 5. Serious adverse events (SAEs) SAEs for 6 months following vaccination 6 months post vaccination
Secondary Outcome 6. Seroprotective rSBA titres Percentage of subjects with rSBA titer of ≥ 8 against serogroups A, C, Y, W, and X at Day 1 and Day 29 At baseline prior to vaccination - Day 1 and 28 days post vaccination - Day 29
Secondary Outcome 7. Long term protective rSBA titres Percentage of subjects with rSBA titer of ≥ 128 against serogroups A, C, Y, W, and X at Day 1 and Day 29 At baseline prior to vaccination - Day 1 and 28 days post vaccination - Day 29
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre pour le Developpement des Vaccins du Mali Bamako, Mali, BP251 Mali Mali
Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine Fajara, Gambia Fajara Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
The Department for International Development DFID 22 Whitehall London SW1A 2EG United Kingdom London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Serum Institute of India Pvt. Ltd. 212/2, Off Soli Poonawlla Road, Hadapsar Pune 411028 India Biotechnology Company
COLLABORATORS
Name Street address City Postal code Country
PATH 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, United States of America Seattle United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Prasad Kulkarni drpsk@seruminstitute.com +912026602384 212/2, Off Soli Poonawalla Road, Hadapsar
City Postal code Country Position/Affiliation
Pune India Medical Director
Role Name Email Phone Street address
Public Enquiries Prasad Kulkarni drpsk@seruminstitute.com +912026602384 Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road, Hadapsar
City Postal code Country Position/Affiliation
Pune 411028 India Medical Director
Role Name Email Phone Street address
Principal Investigator Samba Sow ssow@some.umaryland.edu +22320236031 CENTRE POUR LE DEVELOPPEMENT DES VACCINS - CVD-MALI, Ex- INSTITUT MARCHOUX, BP 2S 1, BAMAKO, MALl
City Postal code Country Position/Affiliation
Bamako Mali Professor of Medicine
Role Name Email Phone Street address
Principal Investigator Ed Clarke Ed.Clarke@lshtm.ac.uk +2204495442 MRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, The Gambia
City Postal code Country Position/Affiliation
Fajara Gambia Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected from this study will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. Other study details are available on on ClinicalTrials.gov. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 6 months of publication of the study data. Local regulatory authorities, ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 01/02/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 01/02/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information