Randomized Phase 3 Study Comparing Three Lots of 21-valent Pneumococcal Vaccine to Licensed 20-valent Vaccine in Healthy Infants Aged 42 to 89 Days

What this Trial Is About

Researchers are evaluating the immune response and safety of three different lots of an investigational 21-valent pneumococcal conjugate vaccine PCV21 compared to a licensed 20-valent pneumococcal vaccine 20vPCV, Prevnar 201d in healthy infants aged approximately 2 months. This phase 3 randomized, modified double-blind study aims to determine if the immune responses generated by the three PCV21 lots are similar and safe in this young population. Participants will receive four doses of either one of the three PCV21 vaccine lots or the 20vPCV licensed vaccine at approximately 2, 4, 6, and 12 months of age. Doses are given by intramuscular injection and administered alongside routine pediatric vaccines as per local guidelines. Two cohorts are involved Cohort A includes randomization to three PCV21 groups or the 20vPCV comparator group, while Cohort B includes randomization only to the three PCV21 groups. During the study, participants will attend six visits spaced over the first year of life, with the last visit occurring about 30 days after the 12-month vaccine dose. Researchers will measure antibody levels IgG 30 days after the third vaccine dose to assess immune response. Safety is monitored through observation of adverse events immediately after vaccination and for up to six months after the last dose. The total participation duration per infant is approximately 17 months.

Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age