Derby

Researchers are evaluating the safety and immune response of a new pneumococcal vaccine compared to the current 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants. This Phase 3 randomized, double-blind trial aims to understand how the new vaccine helps protect against infections like pneumonia, meningitis, and ear infections caused by Streptococcus pneumoniae. The study will measure the bodys protein production to fight these germs and assess if the new vaccine can provide additional protection against strains not covered by existing vaccines. The study divides participants into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months, who will receive either the new vaccine PG4 or 20vPnC by injection into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. Groups 2 and 3, consisting of about 140 and 90 infants respectively from outside the United States aged 2 to 6 months, will receive similar vaccine schedules with some variations in administration routes and timing. Group 3 may receive the new vaccine either intramuscularly or under the skin. The vaccine doses and schedules vary slightly among groups to compare safety and immune responses. Participants will be involved for about 12 to 19 months depending on their group. During this time, there will be six clinic visits and one phone call to monitor for side effects and collect data. Parents or guardians will report any reactions, and infants will have three blood samples taken to measure immune response. Researchers will track local reactions, systemic events, adverse events, and serious adverse events. The study will review antibody levels and immune activity after doses to assess how well the vaccines work and their safety over time.