NCT05731115

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

A Randomized, Double-blind Clinical Trial to Evaluate the Lot Consistency, Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Adults Aged 40-65 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a randomized, double-blind phase Ⅳ clinical trial in subjects aged 40-65 years to evaluate the lot-to-lot consistency,immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1800 subjects will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received one dose of vaccine on day 0.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Experimental 23-valent Pneumococcal	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 mixture per injection.

Timeline

• Start date: 2023-02-27
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2023-02-16
• Last updated: 2023-09-18

Locations

2 sites across 1 country: China