NCT06550830

Clinical Trial of PCV24 in Children Aged 2-17 Years

A Randomized, Double-blind, Controlled Combined With Open-label Phase Ia Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2-17 Years.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

Summary

A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled combined with open-label phase Ia clinical trial.

Detailed description

A phase Ia clinical trial of the study of 24-valent Pneumococcal Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children aged 2-17 years. The trial is a randomized, double-blind, controlled combined with open-label 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 for participants aged 2-5 years is the Prevenar13® manufactured by Pfizer. A total of at least 114 participants will be enrolled, including 24 children aged 6-17 years and 90 children aged 2-5 years. Children aged 6-17 years will receive PCV24 formulation 1 and PCV24 formulation 2 in a 1:1 ratio. Children aged 2-5 years will receive PCV24 formulation 1, PCV24 formulation 2 and Prevenar13® in a 1:1:1 ratio.

Conditions

• Pneumococcal Infectious Disease

Interventions

Type	Name	Description
BIOLOGICAL	Sinovac PCV24 formulation 1	One dose of Sinovac PCV24 formulation 1(0.5mL)
BIOLOGICAL	Sinovac PCV24 formulation 2	One dose of Sinovac PCV24 formulation 2(0.5mL)
BIOLOGICAL	Prevenar13®	One dose of PCV13 manufactured by Pfizer

Timeline

• Start date: 2024-09-07
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2024-08-13
• Last updated: 2026-01-28

Locations

1 site across 1 country: China