Clinical Trial of PCV24 in Children Aged 2-17 Years

NCT06550830 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2026-01-28

No results posted yet for this study

Summary

A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled combined with open-label phase Ia 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

Prevenar13®

One dose of PCV13 manufactured by Pfizer

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
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-07
Primary Completion
2025-06-25
Completion
2025-06-25

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 NCT06550830 on ClinicalTrials.gov