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Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)
Sponsor: Sinovac Life Sciences Co., Ltd.
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
Conditions
Interventions
Sinovac PCV13
One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
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