NCT06800261

Clinical Trial of PCV24 in Infants Aged 2-23 Months

A Randomized, Double-blind, Positive Controlled Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 (Minimum 42 Days)-23 Months

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 42 Days – 23 Months
• Healthy volunteers: Accepted

Summary

A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months. 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 Ib clinical trial.

Detailed description

A phase 1b 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 Chinese pediatric population aged 2 months (minimum 42 days)-23 months. 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 180 participants aged 2 months (minimum 42 days)-23 months will be enrolled. Participants will be randomized in 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: 2025-05-08
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-01-29
• Last updated: 2026-01-28

Locations

2 sites across 1 country: China