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

NCT06678620 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 992

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Pneumococcal Infectious Disease

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.

Sponsors & Collaborators

  • Shanghai Reinovax Biologics Co.,LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2025-04-21
Completion
2026-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06678620 on ClinicalTrials.gov