NCT05447377

A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants

A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,216 (estimated)
• Sponsor: Serum Institute of India Pvt. Ltd. · Industry
• Sex: All
• Age: 9 Months – 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Yellow Fever

Interventions

Type	Name	Description
BIOLOGICAL	SII 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.
BIOLOGICAL	STAMARIL®	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.

Timeline

• Start date: 2022-09-16
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2022-07-07
• Last updated: 2023-11-28

Locations

2 sites across 2 countries: Mali, The Gambia