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Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly

Pneumococcal Infections Clinical Trial

Official title:
Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.

Clinical Trial Description

This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02451969
Study type Interventional
Source Sinovac Biotech Co., Ltd
Contact
Status Completed
Phase Phase 3
Start date April 2015
Completion date February 2017
View Details
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