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Clinical Trial of PCV24 in Adults

NCT06474377 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-04-16

No results posted yet for this study

Summary

A Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in adults aged 18 years and older. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled Phase I clinical trial.

Conditions

  • Pneumococcal Infectious Disease

Interventions

BIOLOGICAL

Sinovac PCV24 formulation 1

One dose of Sinovac PCV24 formulation 1（0.5mL）

BIOLOGICAL

Sinovac PCV24 formulation 2

One dose of Sinovac PCV24 formulation 2（0.5mL）

BIOLOGICAL

Pneumovax®

One dose of Pneumovax® (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 and 33F saccharides.

BIOLOGICAL

Placebo

0.5 mL of 0.9%NaCl solution (normal saline)

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kai Chu · Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2024-08-26
Completion
2025-02-26

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT06474377 on ClinicalTrials.gov