Phase 3 Study Comparing Safety of a New Multivalent Pneumococcal Vaccine to Current Vaccine in Healthy Infants

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants about 2 months old. The study aims to see if the new vaccine is as safe as the existing one and whether it can provide additional protection against infections caused by the Streptococcus pneumoniae germ, including pneumonia, meningitis, and ear infections. This is a phase 3, randomized, double-blinded trial conducted by Pfizer focused on prevention of pneumococcal disease. About 2400 infants will be randomly assigned to receive either the PG4 vaccine or the 20vPnC vaccine. Vaccinations are given by injection into the left thigh muscle at 2, 4, 6, and between 12 to 15 months of age. The study consists of two groups receiving these vaccines according to this schedule. The treatment period spans these vaccination times, with a total participation duration of about 16 to 19 months. During the study, infants will have six clinic visits and one phone call for monitoring. Parents or legal guardians will report any side effects or adverse events their infant experiences after vaccinations. Researchers will evaluate local and systemic reactions within 7 days of each dose, adverse events from the first dose through one month after the third and fourth doses, and serious adverse events up to six months after the last dose. Safety and tolerability data will be collected throughout the study period.

A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants