Heze

Researchers are conducting a Phase 1b clinical trial to study a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd. The trial involves Chinese children aged 2 months (minimum 42 days) to 23 months and aims to evaluate the safety and immune response of PCV24 compared to an existing vaccine, Prevenar13®. This randomized, double-blind, positive-controlled study includes at least 180 participants divided equally between the test and control groups. Participants will receive either Sinovac PCV24 or Prevenar® as a 0.5 mL intramuscular injection, following different immunization schedules according to their age group. The study monitors how the vaccines perform in stimulating immunity and ensuring safety. The trial design maintains blinding and control measures to fairly assess PCV24 against the active control vaccine. During the study, participants will be closely observed for any adverse reactions within 30 days after vaccination. Guardians will provide vaccination records and remain in contact throughout the trial. Safety and immune responses will be regularly checked, and participants' health status will be monitored to ensure well-being. The overall participation period covers the vaccination schedule and follow-up assessments to capture relevant data on vaccine effects and safety.