Phase 1b Study to Test the Safety and Immune Response of Sinovacs 24-Valent Pneumococcal Vaccine in Children Aged 2 Months to 23 Months

What this Trial Is About

Researchers are conducting a Phase 1b clinical trial to evaluate the safety and immune response of a 24-valent pneumococcal conjugate vaccine PCV24 developed by Sinovac Life Science Co., Ltd in children aged 2 months to 23 months. This randomized, double-blind, positive controlled study compares PCV24 with the active control vaccine Prevenar134 from Pfizer and aims to provide important information about the vaccines effects in young children. Participants aged 2 months to 23 months will be randomly assigned to receive either the Sinovac PCV24 or Prevnar134 vaccine. Both vaccines will be given by intramuscular injection following specific immunization schedules. For infants under 12 months, the injection will be administered in the anterolateral thigh, while for those older than 12 months, the injection will be given in the deltoid muscle of the upper arm. During the study, children will be monitored for adverse reactions for up to 30 days after vaccination, including serious adverse events for six months after the final dose. Researchers will measure immune responses through blood tests 30 days after the primary vaccination to assess antibody levels against pneumococcal serotypes. The study requires participants to follow study procedures and stay in contact throughout the trial, which is expected to continue until June 2026.

Clinical Trial of PCV24 in Infants Aged 2-23 Months