NCT06474377

Clinical Trial of PCV24 in Adults

A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Adults 18 Years of Age and Older

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in adults aged 18 years and older. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled Phase I clinical trial.

Detailed description

A phase I 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 adults aged 18 years and older. The trial is a randomized, double-blind and active 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 the Pneumovax® manufactured by MSD. The placebo is 0.9%NaCl solution. A total of at least 168 participants will be enrolled, including 84 adults aged 18-59 years and 84 elderly people aged ≥60 years. Participants will be randomized in a 2:2:2:1 ratio to receive one dose of PCV24 formulation 1, PCV24 formulation 2, Pneumovax® or placebo.

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	Pneumovax®	One dose of Pneumovax® (0.5 mL) contains 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F saccharides.
BIOLOGICAL	Placebo	0.5 mL of 0.9%NaCl solution (normal saline)

Timeline

• Start date: 2024-06-21
• Primary completion: 2024-08-26
• Completion: 2025-02-26
• First posted: 2024-06-25
• Last updated: 2025-04-16

Locations

1 site across 1 country: China