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NOT YET RECRUITING
NCT07832500
PHASE3

A Lot-to-Lot Consistency Clinical Trial of PCV13

Sponsor: Sinovac Life Sciences Co., Ltd.

View on ClinicalTrials.gov

Summary

A Phase IIIb clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 to 5 years. The objective of the study is to evaluate the the Lot-to-Lot consistency, immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind phase IIIb clinical trial.

Official title: A Randomized, Double-Blind Phase Ⅲb Clinical Trial to Evaluate the Lot-to-Lot Consistency, Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in Children Aged 2 to 5 Years

Key Details

Gender

All

Age Range

2 Years - 5 Years

Study Type

INTERVENTIONAL

Enrollment

1125

Start Date

2026-09

Completion Date

2027-03

Last Updated

2026-09-22

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Sinovac PCV13 lot 1

One dose of Sinovac PCV13 lot 1 (0.5ml) was administered

BIOLOGICAL

Sinovac PCV13 lot 2

One dose of Sinovac PCV13 lot 2 (0.5ml) was administered

BIOLOGICAL

Sinovac PCV13 lot 3

One dose of Sinovac PCV13 lot 3(0.5ml) was administered

Locations (1)

Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention (Xinjiang Uygur Autonomous Region Academy of Preventive Medicine, Xinjiang Uygur Autonomous Region Public Health Inspection and Testing Center)

Ürümqi, Xinjiang, China