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ACTIVE NOT RECRUITING
NCT06678620
PHASE2

Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

Sponsor: Shanghai Reinovax Biologics Co.,LTD

View on ClinicalTrials.gov

Summary

A phase II clinical trial of a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial.

Official title: A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

992

Start Date

2024-04-20

Completion Date

2026-03

Last Updated

2025-12-17

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Reinovax PCV24 formulation 1

One dose of Reinovax PCV24 formulation 1(0.5mL)

BIOLOGICAL

Reinovax PCV24 formulation 2

One dose of Reinovax PCV24 formulation 1(0.5mL)

BIOLOGICAL

Reinovax PCV24 formulation 3

One dose of Reinovax PCV24 formulation 1(0.5mL)

BIOLOGICAL

PPSV23

One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides.

Locations (2)

Pizhou Center for Disease Control and Prevention

Pizhou, Jiangsu, China

Xuzhou Center for Disease Control and Prevention

Xuzhou, Jiangsu, China