A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
This is a phase 3 randomized, modified double-blind study which purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called antibodies (immunogenicity) in a similar way (ie, same immune response) when they are given in infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV vaccines) will be administered at approximately 2, 4, 6 and 12 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, V06 separated from V05 by 30 days
• Aged 42 to 89 days on the day of inclusion
• Participants who are healthy as determined by medical evaluation including medical history and physical examination
• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable