Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine

Summary

This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.

Timeline

Start

2023-02-27

Primary completion

2023-05-05

Completion

2023-05-05

Publications

• Zhang Y, Shi G, Zhou S, Zhao W, Wang L, Li J, Zhao Z, Li G, Geng J, Chen Z, Zhao H, Li Y, Xu L, Wang B, Jiao P, Li G. Lot-to-lot consistency, immunogenicity, and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy adults aged 40-65 years: A randomized, double-blind, controlled, phase IV clinical trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579366. doi: 10.1080/21645515.2025.2579366. Epub 2025 Oct 30.

Drugs

Indications