20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Purpose
This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
Condition
- Pneumococcal Disease
Eligibility
- Eligible Ages
- Between 42 Days and 98 Days
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1). - Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. - Major known congenital malformation or serious chronic disorder.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 20-valent pneumococcal conjugate vaccine |
Pneumococcal conjugate vaccine |
|
|
Active Comparator 13-valent pneumococcal conjugate vaccine |
Pneumococcal conjugate vaccine |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer