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

NCT05447377 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2216

Last updated 2023-11-28

No results posted yet for this study

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.

Conditions

  • Yellow Fever

Interventions

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.

Sponsors & Collaborators

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2024-01-30
Completion
2024-01-30

Countries

  • Mali
  • The Gambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447377 on ClinicalTrials.gov