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RECRUITING
NCT06800261
PHASE1

Clinical Trial of PCV24 in Infants Aged 2-23 Months

Sponsor: Sinovac Life Sciences Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-blind, Positive Controlled Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 (Minimum 42 Days)-23 Months

Key Details

Gender

All

Age Range

42 Days - 23 Months

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-05-08

Completion Date

2026-06

Last Updated

2026-01-28

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 (2)

Shandong Provincial Center for Disease Control and Prevention

Jinan, Shandong, China

Shanxian Center for Disease Control and Prevention

Shancheng, Shandong, China