A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
Recruiting
Phase 3
Interventional Study
Pneumococcal Infections
Streptococcal Infections
Bacterial Infections
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 6 Weeks – 2 Months
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 600 (estimated)
- Sponsor
- CanSino Biologics Inc. · Industry
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About This Trial
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 mont…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Healthy infants with stable clinical conditions aged 2 months (42-90 days) at the time of screening, based on medical history and clinical assessment by the investigator. Infants will be eligible starting from the day they turn 6 weeks of age.
* Infant's parent or legal guardi…
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