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A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT06183216 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-01-28

No results posted yet for this study

Summary

A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV13. The trial is a randomized, double blinded, positive controlled study.

Conditions

  • Pneumococcal Infectious Disease

Interventions

BIOLOGICAL

Sinovac PCV13

0.5 mL dose of Sinovac PCV13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

BIOLOGICAL

PREVNAR 13

0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

Sponsors & Collaborators

  • Sinovac Research and Development Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yan Zheng · Yunnan Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-04
Primary Completion
2025-03-26
Completion
2025-03-26

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 NCT06183216 on ClinicalTrials.gov