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Clinical Trial of PCV24 in Infants Aged 2-23 Months

NCT06800261 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-01-28

No results posted yet for this study

Summary

A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months.

The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase Ib clinical trial.

Conditions

  • Pneumococcal Infectious Disease

Interventions

BIOLOGICAL

Sinovac PCV24

Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.

BIOLOGICAL

Prevnar®

Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qing Xu · Shandong Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-08
Primary Completion
2026-06-30
Completion
2026-06-30

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 NCT06800261 on ClinicalTrials.gov