UnknownPhase 3

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

Mali, The Gambia2,216 participantsStarted 2022-09-16

Plain-language 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.

Who can participate

Age range9 Months – 12 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy infants as established by medical history and clinical examination
✓. 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)
✓. Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements.
✓. Intend to remain residing in the study area throughout study participation
✓. Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants for the duration of the study

Exclusion criteria

✕. Fever (\> 37.5°C) or any clinically significant acute infection at time of vaccination \[Temporary exclusion criteria - participants may be rescreened at least 48 hours after the last recorded fever\].
✕. Previous history of laboratory confirmed infection with yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.

What they're measuring

YF neutralizing antibody (NAb) seroconversion

Timeframe: Day 28 post-vaccination

Trial details

NCT IDNCT05447377

SponsorSerum Institute of India Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-30

Contact for this trial

Dr Prasad Kulkarni, MD

00912071946820 drpsk@seruminstitute.com

View on ClinicalTrials.gov More Yellow Fever trials