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

Last updated: November 22, 2023
Sponsor: Serum Institute of India Pvt. Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Fever

Treatment

SII Yellow Fever Vaccine

STAMARIL®

Clinical Study ID

NCT05447377
YWF:02
  • Ages 9-12
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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-ageuntil the day before they reach 12-months/1-year-of-age)
  3. Parental/ guardian ability and willingness to provide informed consent (as per localrequirements/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 andtreatments in infants for the duration of the study

Exclusion

Exclusion Criteria:

  1. Fever (> 37.5°C) or any clinically significant acute infection at time of vaccination [Temporary exclusion criteria - participants may be rescreened at least 48 hours afterthe last recorded fever].
  2. Previous history of laboratory confirmed infection with yellow fever, measles, mumps,rubella, Neisseria meningitidis serogroup A, and other flaviviruses e.g., denguefever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
  3. Previous vaccination against yellow fever, measles, mumps, rubella, Neisseriameningitidis serogroup A, TBE, JE, or dengue fever.
  4. Receipt of any vaccine within past 28 days or planned vaccination until completion ofday 28 study visit 7. A known hypersensitivity to any of the vaccine components (includinggelatin, eggs, egg products, or chicken protein) or history of a life threatening reactionto any past vaccine 8. Receipt of immunoglobulin therapy and/or blood products since birthor planned administration until completion of Day 28 visit 9. Current or plannedparticipation in another interventional study at any point throughout the entire studyperiod 10. Receipt of any other investigational product or unlicensed medication in thepreceding 28 days, or planned use until completion of Day 28 visit 7. Presence ofsignificant malnutrition (weight-for-height z-score < -3SD)

Study Design

Total Participants: 2216
Treatment Group(s): 2
Primary Treatment: SII Yellow Fever Vaccine
Phase: 3
Study Start date:
September 16, 2022
Estimated Completion Date:
January 30, 2024

Study 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.

Connect with a study center

  • MRC Unit The Gambia at LSHTM

    Banjul, 273
    Gambia

    Active - Recruiting

  • Center for Vaccine Development

    Bamako, 251
    Mali

    Active - Recruiting

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