Comparing the safety and immune response of two yellow fever vaccines in healthy infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III clinical trial is a double-blind, multi-center, randomized, active-controlled study involving healthy infants aged 9 to less than 12 months. Participants will receive either the SII Yellow Fever Vaccine or STAMARIL®, a licensed yellow fever vaccine, alongside MMR and Men A vaccines. The study will assess the safety and immunogenicity of the vaccines over a series of scheduled visits, starting with vaccination and followed by evaluations at 28 and 180 days post-vaccination. Parental consent and adherence to protocol are required for participation.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

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

5. Previous vaccination against yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, TBE, JE, or dengue fever.

6. Receipt of any vaccine within past 28 days or planned vaccination until completion of day 28 study visit 7. A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life threatening reaction to any past vaccine 8. Receipt of immunoglobulin therapy and/or blood products since birth or planned administration until completion of Day 28 visit 9. Current or planned participation in another interventional study at any point throughout the entire study period 10. Receipt of any other investigational product or unlicensed medication in the preceding 28 days, or planned use until completion of Day 28 visit 7. Presence of significant malnutrition (weight-for-height z-score \< -3SD)

Where it's running

• MRC Unit The Gambia at LSHTM
  Banjul, Gambia Recruiting
• Center for Vaccine Development
  Bamako, Mali Recruiting

Study contacts

• Study coordinator: Dr Prasad Kulkarni, MD
• Email: drpsk@seruminstitute.com
• Phone: 00912071946820

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.