NCT07300644

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

A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 Months (Minimum 42 Days) to 5 Years

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 42 Days – 5 Years
• Healthy volunteers: Accepted

Summary

A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase 2 clinical trial.

Detailed description

A phase 2 clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in the Chinese pediatric population aged 2 months (minimum 42 days) to 5 years. The trial is a randomized, double-blind, positive-controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13®, manufactured by Pfizer. A total of at least 420 participants aged 2 months (minimum 42 days) to 5 years will be enrolled. Participants will be randomized in a 1:1 ratio to the test group and control group.

Conditions

• Pneumococcal Infectious Disease

Interventions

Type	Name	Description
BIOLOGICAL	Sinovac PCV24	Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.
BIOLOGICAL	Prevnar®	Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-09-01
• Completion: 2027-12-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

3 sites across 1 country: China