Yellow Fever
Conditions
Brief summary
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
Detailed description
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV. A single dose of either SII-YFV or STAMARIL® will be administered concomitantly with an MMR and a Men A vaccine. The study will start only after the approval from the applicable ethics committees and national regulatory agencies. Following parental / guardian consent, participants will be screened for eligibility based on the defined inclusion and exclusion criteria for the trial. There will be three scheduled visits during the study. A screening and vaccination visit (Day 0) followed by additional study visits on Day 28 and on Day 180 post-vaccination.
Interventions
BIOLOGICALSII Yellow Fever Vaccine
SII YF vaccine: Live attenuated Yellow Fever Virus (17D-213 Strain) not less than 1000 IU/dose propagated in specific pathogen-free chick embryos. SII-YFV contains the 17D-213 vaccine strain, a derivative of 17D-204 strain which is used in many currently produced yellow fever vaccines. SIIPL imported the YF WHO Primary Seed Virus lot 213-77 from National Institute for Biological Standards and Control (NIBSC) for preparation of the master seed virus, working seed virus and the vaccine. After reconstitution, 1 dose (0.5 mL) contains: * Yellow fever virus 17D-213 strain (live, attenuated) not less than 1000 IU propagated in specific pathogen-free chick embryos * Excipients with known effects: * This product contains approximately 5 mg of sorbitol per dose.
BIOLOGICALSTAMARIL®
STAMARIL® contains the 17D-204 vaccine strain, which is used in many currently produced yellow fever vaccines. STAMARIL® is specific pathogen free embryonated hen's egg based and is prepared by harvesting and stabilizing the virus collected from the homogenized chicken embryos infected with YF vaccine virus. STAMARIL® will be used as a comparator in the study. It is a live, attenuated, freeze-dried (lyophilized) vaccine and is to be reconstituted with solvent. After reconstitution, 1 dose (0.5 mL) contains: * Yellow fever virus 17D-204 strain (live, attenuated) not less than 1000 IU propagated in specific pathogen-free chick embryos * Excipients with known effects: * This product contains approximately 8 mg of sorbitol (E420) per dose.
Sponsors
Serum Institute of India Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infants as established by medical history and clinical examination 2. Male or female infants aged 9 to \< 12 months (from the day they reach 9 months-of-age until the day before they reach 12-months/1-year-of-age) 3. Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements. 4. Intend to remain residing in the study area throughout study participation 5. Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants for the duration of the study
Exclusion criteria
1. Fever (\> 37.5°C) or any clinically significant acute infection at time of vaccination \[Temporary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| YF neutralizing antibody (NAb) seroconversion | Day 28 post-vaccination | Non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT50). Percentage seroconversion\* on Day 28 post-vaccination \* Seroconversion is defined as a four-fold rise in YF NAb (PRNT50) titres from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yellow Fever Vaccine GMTs | Day 0 pre-vaccination and Day 28 post-vaccination | GMTs on Day 0 pre-vaccination and Day 28 post-vaccination Equivalence of the immune responses generated by three different manufacturing lots of SII-YFV |
Countries
Mali, The Gambia
Contacts
Primary ContactDr Prasad Kulkarni, MD
Backup ContactDr Sajjad Desai, MD
Outcome results
None listed