NCT06314867

Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23

A Single Center, Randomized, Double-blind, and Intergroup Control Clinical Study to Evaluation on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of 23 Valent Pneumococcal Polysaccharide Vaccine

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 990 (actual)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.

Detailed description

This study adopted a randomized, double-blind, equivalency design with different batches of experimental vaccine. 990 individuals aged 18-59 were included and divided into three groups at a ratio of 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, intramuscularly injected into the lateral deltoid muscle of the upper arm.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)	All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112011), intramuscularly injected into the lateral deltoid muscle of the upper arm.
BIOLOGICAL	23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)	All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112012), intramuscularly injected into the lateral deltoid muscle of the upper arm.
BIOLOGICAL	23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)	All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112013), intramuscularly injected into the lateral deltoid muscle of the upper arm.

Timeline

• Start date: 2023-01-30
• Primary completion: 2024-12-30
• Completion: 2028-06-30
• First posted: 2024-03-18
• Last updated: 2024-04-04

Locations

1 site across 1 country: China