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

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

This study is testing two different yellow fever vaccines in healthy infants to see which one is safer and works better to boost their immune response.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2216 (estimated)
• Ages: 9 Months to 12 Months
• Sex: All
• Sponsor: Serum Institute of India Pvt. Ltd. (Industry-sponsored)
• Locations: 2 sites (Banjul and 1 other locations)
• Trial ID: NCT05447377 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy infants aged 9 to less than 12 months who can provide informed consent through their parents or guardians.

Not a fit: Patients with a history of yellow fever infection or significant acute infections at the time of vaccination may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into a safer and more effective yellow fever vaccination option for infants.

How similar studies have performed: Previous studies have shown success with similar vaccine comparisons, indicating potential for meaningful results in this trial.

Eligibility criteria

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 this trial is running

Banjul and 1 other locations

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

Study contacts

• Study coordinator: Dr Prasad Kulkarni, MD

Conditions Yellow Fever