NCT04989465

A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine

An Open Phase Ⅳ Clinical Trial to Evaluate the Immunity Persistence After Single Dose of 23-valent Pneumococcal Polysaccharide Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 2 Years – 110 Years
• Healthy volunteers: Accepted

Summary

This an open 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 immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.

Detailed description

This study is an open phase Ⅳ clinical trial to evaluate the immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd..A total of 600 subjects including 450 subjects in the experimental group and 150 subjects in the control group who participated in the second stage of phase Ⅲ clinical trial (PPS)will be enrolled .Based on the age at the time of enrollment in the phase Ⅲ study, there will be 150 participants in each age group (2-17 years old group, 18-60 years old group and ≥61 years old) in the experimental group and 50 participants in each age group in the control group .3.0-3.5ml of venous blood will be collected from all subjects after enrollment.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Investigational 23-valent PPV	The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection
BIOLOGICAL	Control 23-valent PPV	The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd. 25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of light disodium phenol phosphate, sodium hydrogen phosphate and sodium chloride per injection

Timeline

• Start date: 2021-09-10
• Primary completion: 2021-09-13
• Completion: 2021-09-13
• First posted: 2021-08-04
• Last updated: 2022-08-12

Locations

1 site across 1 country: China