NCT05421611

A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,824 (actual)
• Sponsor: Serum Institute of India Pvt. Ltd. · Industry
• Sex: All
• Age: 1 Year – 99 Years
• Healthy volunteers: Accepted

Summary

The study is designed as a Phase III, double-blind, multicenter, randomized, active-controlled, parallel-group design in which two groups of participants will receive either SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV. The study will start only after the approval from the applicable ethics committees and national regulatory agencies.

Detailed description

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. Throughout the study, participants/parent/guardian will be encouraged to contact the study team if the participant is unwell and the study team will additionally maintain contact with study participants. The participant or parent/guardian will be contacted telephonically on Day 90 to enquire about participant's health and occurrence of any serious adverse events (SAEs). Active surveillance for vaccine reactogenicity will be conducted in reactogenicity cohort from the time of vaccination (Day 0) until Day 10 following vaccination. Unsolicited AE will be collected from all study participants until Day 28 post vaccination. SAEs will be collected from all participants throughout the study (to Day 180).

Conditions

• Yellow Fever

Interventions

Type	Name	Description
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.
BIOLOGICAL	SII-YFV	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. The SII-YFV 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 working seed virus. SII-YFV will be provided in vial presentation for the study. It is a live, attenuated, freeze-dried (lyophilized) vaccine and is to be reconstituted with sterile water for injection.

Timeline

• Start date: 2023-05-11
• Primary completion: 2024-05-10
• Completion: 2024-05-10
• First posted: 2022-06-16
• Last updated: 2025-05-07

Locations

2 sites across 1 country: Kenya