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.: PACTR202405741158761 Date of Approval: 23/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison Study of Immunogenicity and Safety of SIBP’s Measles, Mumps and Rubella (MMR) Vaccine versus WHO prequalified GSK Measles, Mumps and Rubella (MMR) Vaccine
Official scientific title A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.’s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9- 11 Months of Age.
Brief summary describing the background and objectives of the trial Measles is one of the most contagious diseases for humans. Measles complications such as pneumonia, diarrhea and encephalitis can occur in up to 30% of persons depending on age and predisposing conditions, such as young age, malnutrition and immunocompromising conditions. Mumps is an infectious viral disease transmitted via respiratory droplets, fomites, or personal contact. Some infected individuals develop severe complications such as orchitis, pancreatitis, septic meningitis, and deafness. Rubella is a mild viral infection that typically occurs in children and non-immune young adults. In nonpregnant individuals, rubella is generally a self-limited and benign infection. However, maternal rubella infection, especially during embryogenesis leads to the classic triad of cataracts, congenital heart defects, and sensorineural deafness; however, other defects may be seen including miscarriages, fetal death, or severe birth defects collectively known as Congenital Rubella Syndrome (CRS). Yellow fever (YF) is a mosquito borne viral disease caused by RNA virus belonging to Flavivirus genus of the Flaviviridae family. This virus is transmitted by Aedes aegypti and Haemagogous species mosquitoes, during the rainy season. This disease is endemic in the tropical and subtropical areas in South America and Africa. The current study is designed to compare the safety and immunogenicity of SIBP MMR administered alone with that of GSK MMR vaccine administered alone in the African context and to evaluate the interaction of co-administration of SIBP MMR vaccine with YF vaccine in children 9-11months of age, in terms of immune responses against antigens contained in both vaccines The results of this study is expected to complete the package required for applying for WHO pre-qualification for the SIBP MMR vaccine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SIBPMMR02
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Measles, Mumps and Rubella MMR Vaccine
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 17/06/2024
Actual trial start date
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site 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 SIBP MMR vaccine followed by licensed Yellow Fever Vaccine Single dose 0.5 mLfollowed by 0.5 mL dose of yellow fever vaccine after 6 weeks Single dose followed by dose of yellow fever vaccine after 6 weeks 400 children in group receiving a single dose of SIBP MMR vaccine followed by licensed Yellow Fever(YF) vaccine after 6 weeks (Group 1, MMR1YF2) 400
Control Group GSK MMR vaccine Single 0.5 mL dose alone at D1 Single dose at D1 Single dose of GSK MMR vaccine alone at D1 (GSK MMR1) 400 Active-Treatment of Control Group
Experimental Group SIBP MMR vaccine and Yellow Fever vaccine o.5 mL SIBP MMR vaccine co-administered with 0.5mL Yellow Fever vaccine Single dose o.5 mL SIBP MMR vaccine co-administered with 0.5mL Yellow Fever vaccine 400
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Healthy male and female child as established by medical history and clinical examination at enrollment. 2. Age: 9-11 months (inclusive) at the time of enrollment 3. Parent’s/legally acceptable representative’s (LAR) ability to read and willingness to provide written informed consent as per the ethical and regulatory requirements of the site. 4. Parent confirms intention to stay in the study area for the study duration, bring their child in for the required study visits or to accept a home visit by the study staff. 1. Presence of fever (defined as axillary temperature ≥ 37.5°C) (temporary exclusion until recovery) 2. Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery) 3. Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery) 4. Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study 5. Presence of severe malnutrition (weight-for-height z-score < -3SD median) 6. Positive test for any of the following: HIV, hepatitis B, hepatitis C and syphilis 7. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological (including severe anemia), endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant’s health or is likely to result in nonconformance to the protocol. 8. Known or suspected impairment of immunological function based on medical history and physical examination. 9. Prior receipt or intent to receive measles, mumps, rubella, or yellowfever-containing vaccine during the study vaccination and follow up period up to Day 85 outside the study center. 10. Receipt of any vaccine (except OPV and inactivated influenza) within 4 weeks of the day of study vaccination or intent to receive any within 6 weeks after study vaccination. 11. Receipt of immunoglobulin therapy and / or blood products in the past 9 months or planned administration during the study period 12. Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study. A chronic oral or parenteral use (defined as more than 14 days) of high dose corticosteroids (defined as ≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh >10 kg) will be exclusionary for the study. Children o Infant: 1 Month-23 Month 9 Month(s) 11 Month(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 28/12/2023 JOOTRH ISREC
Ethics Committee Address
Street address City Postal code Country
Jaramogi Oginga Odinga Teaching and reffreal Hospital, P.O. Box 849 Kisumu 40-100 Kenya
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 12/04/2024 JOOTRH ISERC
Ethics Committee Address
Street address City Postal code Country
Jaramogi Oginga Odinga Teaching and reffreal Hospital, P.O. Box 849 Kisumu 40-100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immunogenicity To demonstrate non-inferiority of SIBP MMR vaccine compared to GSK MMR vaccine when administered individually based on immunogenicity as measured at baseline and 42 days after vaccination. Baseline and 42 days after vaccination.
Secondary Outcome Safety -To assess the safety of SIBP MMR vaccine compared with the GSK MMR vaccine when administered alone in terms of immediate post-vaccination reactogenicity events, solicited adverse events, unsolicited adverse events and serious adverse events. -To assess the safety of the SIBP MMR vaccine co-administered with YF vaccine compared with SIBP MMR vaccine when administered separately from YF vaccine in terms of immediate post- vaccination reactogenicity events, solicited adverse events, unsolicited adverse events, and serious adverse events. Immunogenicity -To evaluate the immunological interference of SIBP MMR vaccine and a licensed YF vaccine when co-administered compared to the immunogenicity when administered alone, in terms of seropositivity rate as measured at baseline and 42 days after vaccination in seronegative children, 9-11 months of age. Baseline and 42 days after vaccination in seronegative children, 9-11 months of age.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Victoria Biomedical Research Institute Kisumu County Referal Hospital, Off Angwa Road, P.O.BOX 7180 Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Shanghai Institute of Biological Products Co. Ltd Guangfeng Road Shanghai 758 China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shanghai Institute of Biological Products Co. Ltd SIBP 758 Guangfeng Road Shanghai 758 China Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dr Walter Otieno wotieno@vibriafrica.org +254714481488 Victoria Biomedical Institute, Kisumu County Hospital
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Walter Otieno wotieno@vibriafrica.org +254714481488 Victoria Biomedical Institute, Kisumu County Hospital
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Public Inqueries
Role Name Email Phone Street address
Scientific Enquiries Diana Odhiambo dodhiambo@vibriafrica.org +254722243110 Victoria Biomedical Institute, Kisumu County Hospital
City Postal code Country Position/Affiliation
Kisumu 40100 Kiribati Scientific Inqueries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Electronic case report form(eCRF) screens will be made available to sites for data entry. Participants willnot be identified by name on any data submitted to PSRT. Participants will be identified by subject numbers provided by the Clinical Data Management System upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summary will be shared when the final study clinical report is available 12 months post study completion. The results of this trial will add to the body of scientific knowledge on the safety and immune responses of the Yellow Fever and Measle Mumps Rubella vaccines in the general population. The final study results will be shared with the study team, the study participants, the medical community, the study sponsor, study funder and the public. The results will be published in peer reviewed scientific journals, abstracts, posters and symposium presentations at local and international conferences. Study reports will focus on the background information, study methodology, results and discussion formats. The results will be shared with the media and through dissemination activities with relevant stakeholders including the Ministry of Health. It is anticipated that the information will assist stakeholders and policy makers in designing appropriate interventions and inform practice. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Results will be shared within 12 months of study completion. To be confirmed and updated
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be updated once available 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