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NOT YET RECRUITING
NCT07593924
PHASE3

Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)

Sponsor: Sinovac Life Sciences Co., Ltd.

View on ClinicalTrials.gov

Summary

A Phase III clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in infants aged approximately 2 months (42 to 89 days). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind, active controlled phase III clinical trial.

Official title: A Phase III, Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Administered as a Series of 2 Infant Doses and 1 Toddler Dose in Healthy Infants

Key Details

Gender

All

Age Range

42 Days - 89 Days

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-05

Completion Date

2027-07

Last Updated

2026-05-18

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Sinovac PCV13

One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.

BIOLOGICAL

Prevenar 13™

One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.

Locations (1)

Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences

Imus, Cavite, Philippines