NCT02451969

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,760 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	investigational 23-valent PPV	The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.
BIOLOGICAL	control 23-valent PPV	The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-06-01
• Completion: 2017-02-01
• First posted: 2015-05-22
• Last updated: 2017-05-03

Locations

1 site across 1 country: China