drugset
drugset / Trial / NCT06824194

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

NCT06824194 ↗

Phase 3 Active not recruiting 2360 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Timeline

Start
2025-02-18
Primary completion
2027-10-22
Completion
2027-10-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator PCV20 Vaccine — Intramuscular
Subject PCV21 Vaccine — Intramuscular
Background Havrix Vaccine — Intramuscular
Background M-M-R II Vaccine — Subcutaneous
Background Pentacel Vaccine — Intramuscular
Background Priorix Vaccine — Subcutaneous
Background Rotarix Vaccine — Oral
Background Vaqta Vaccine — Intramuscular
Background Varivax Vaccine — Subcutaneous

Indications

No indication recorded.