20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Purpose
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series 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 >36 weeks of gestation and 2 months of age at the time of consent. - Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) - Major known congenital malformation or serious chronic disorder - Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results - Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
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