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Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine

NCT06617715 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3080

Last updated 2026-01-28

No results posted yet for this study

Summary

A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.

Conditions

  • Pneumococcal Infectious Disease

Interventions

BIOLOGICAL

Sinovac PCV13

One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.

BIOLOGICAL

Prevnar®

One dose of Prevnar® (0.5 mL) is administered intramuscularly.

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanxia Wang · Henan Provincial Center for Disease Control and Prevention

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
2024-10-23
Primary Completion
2026-05-12
Completion
2026-07-30

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 NCT06617715 on ClinicalTrials.gov