NCT06617715

Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine

A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,080 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 6 Weeks – 5 Years
• Healthy volunteers: Accepted

Summary

A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.

Detailed description

A phase Ⅲ clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese pediatric population aged 2 months (minimum 6 weeks)-5 years (before the 6th birthday). The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13®. A total of at least 3080 participants aged 6 weeks to 5 years will be enrolled. Participants will be randomized in 1:1 ratio to the test group or control group.

Conditions

• Pneumococcal Infectious Disease

Interventions

Type	Name	Description
BIOLOGICAL	Sinovac PCV13	One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.
BIOLOGICAL	Prevnar®	One dose of Prevnar® (0.5 mL) is administered intramuscularly.

Timeline

• Start date: 2024-10-23
• Primary completion: 2026-05-12
• Completion: 2026-07-30
• First posted: 2024-09-27
• Last updated: 2026-01-28

Locations

1 site across 1 country: China