Actively Recruiting
A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
Led by CanSino Biologics Inc. · Updated on 2026-02-27
600
Participants Needed
3
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants aged 2 months (42-90 days) with stable clinical conditions at screening
- Infants must be at least 6 weeks old on the day of enrollment
- Parent or legal guardian able and willing to provide informed consent
- Participants and guardians able to comply with all trial procedures and available for full follow-up
- Parent or guardian must have a stable residence in the study area and reliable telephone access
You will not qualify if you...
- Infants born before 35 weeks of gestation
- Previous receipt of any pneumococcal vaccine
- Current or recent participation in another interventional clinical trial
- Axillary temperature of 37.86C or higher at enrollment (must wait until recovery)
- Congenital abnormalities, chronic medical conditions, genetic disorders, severe malnutrition, or inherited diseases affecting study outcomes
- History of anaphylactic shock or serious allergic reaction to prior vaccines or vaccine components
- History of epilepsy or convulsions
- Use of immunosuppressive, cytotoxic, or systemic steroid treatments longer than 2 weeks (exceptions apply)
- Receipt or planned receipt of blood/plasma products or immunoglobulins during study
- History of coagulation or blood disorders causing anemia or bleeding
- Known or suspected immunodeficiency
- Vaccination with other vaccines within 7 days before enrollment
- Any condition or therapy that could interfere with study results or participation
- Direct descendant of study staff or sponsor employees
- Any other condition judged by investigator to interfere with the study or pose risk to participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
Actively Recruiting
2
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Actively Recruiting
3
Phramongkutklao Hospital
Bangkok, Thailand
Actively Recruiting
Research Team
M
Meixu Yan
CONTACT
L
Lina Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here