Phase 2 Study to Evaluate the Safety and Immune Response of Sinovacs 24-valent Pneumococcal Vaccine in Children Aged 2 Months to 5 Years

What this Trial Is About

Researchers are evaluating the safety and immune response of a new 24-valent pneumococcal conjugate vaccine called PCV24 in children aged 2 months to 5 years. This phase 2 clinical trial is randomized, double-blind, and compares PCV24 to an existing vaccine, Prevenar13, to better understand its effects in young children. The study is sponsored by Sinovac Life Sciences Co., Ltd and aims to gather important data on this vaccines performance in the pediatric population. Participants will be randomly assigned to receive either the Sinovac PCV24 vaccine or the Prevenar vaccine. Both vaccines are given as 0.5 mL injections into the muscle, following age-appropriate immunization schedules. The trial includes different age groups within the 2 months to 5 years range, ensuring the vaccine is assessed across a broad pediatric population. During the study, children will be monitored for immune response by measuring pneumococcal serotype-specific antibodies 30 days after vaccination. Safety is also closely observed, tracking any adverse reactions within 30 days and serious events up to six months after the last dose. Guardians will be required to follow study procedures and maintain contact throughout the trial, which will continue until December 2027.

Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years