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A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
Sponsor: CanSino Biologics Inc.
Summary
This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 months (at least 6 weeks) who will be randomly assigned in a 1:1 ratio to receive either the experimental or control vaccine, with 100 in each group (200 in total) randomized to subgroups and subject to additional immunogenicity assessments. All participants will be evaluated for solicited adverse events for 7 days and unsolicited adverse events for 30 days post each vaccination. Immunogenicity evaluation will be performed in all participants at baseline and post the booster dose, while the sub-cohort participants will be evaluated for post primary series immunogenicity additionally.
Official title: A Phase III, Observer-blind, Randomized Controlled Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
Key Details
Gender
All
Age Range
6 Weeks - 2 Months
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-11-14
Completion Date
2028-05-15
Last Updated
2026-02-27
Healthy Volunteers
Yes
Interventions
PCV13i
3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)
Prevnar 13
3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)
Locations (3)
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand