Guayama

Researchers are evaluating the safety and immune response of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants. The study aims to understand how well the new vaccine helps fight germs causing pneumonia, meningitis, and ear infections. This phase 3 trial involves infants aged 2 to 6 months and seeks to determine if the new vaccine is as safe as the existing one while assessing its immune response when given alongside other childhood vaccines. Participants are divided into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months who receive either PG4 or 20vPnC by injection into the left thigh muscle at ages 2, 4, 6, and 12 to 15 months. Groups 2 and 3, with about 230 infants outside the United States aged 2 to 6 months, receive vaccinations on a slightly different schedule, with Group 3 exploring both intramuscular and subcutaneous administration of PG4. Participants have a randomized chance of receiving one of the study vaccines. During the study, infants will attend six clinic visits and one phone call where parents report any side effects. Blood samples will be collected three times to assess the immune response by measuring proteins that fight the germs. Researchers will track local and systemic reactions, adverse events, and serious adverse events throughout the study period, which lasts about 1 to 1.5 years depending on the group. The study monitors safety closely to compare the new vaccines effects with the current standard vaccine.

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.