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RECRUITING
NCT07300644
PHASE2

Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years

Sponsor: Sinovac Life Sciences Co., Ltd.

View on ClinicalTrials.gov

Summary

A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 years. 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 2 clinical trial.

Official title: A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 Months (Minimum 42 Days) to 5 Years

Key Details

Gender

All

Age Range

42 Days - 5 Years

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2025-11-25

Completion Date

2027-12

Last Updated

2025-12-24

Healthy Volunteers

Yes

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.

Locations (3)

Qichun District Center for Disease Prevention and Control

Huanggang, Hubei, China

Xiangzhou District Center for Disease Prevention and Control

Xiangyang, Hubei, China

Xian'an District Center for Disease Prevention and Control

Xianning, Hubei, China