Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06314867
PHASE3

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

Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

990

Start Date

2023-01-30

Completion Date

2028-06-30

Last Updated

2024-04-04

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, China