Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
Purpose
This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age
Condition
- Pneumococcal Disease
Eligibility
- Eligible Ages
- Between 15 Months and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Male or female children ≥15 months to <18 years of age at the time of consent. - Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. - For children <5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered >2 months before enrolment into 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 vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation - Cohorts 3 and 4: Pregnant or breastfeeding female participants
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1: =>15 through 23 months of age |
20vPnC |
|
|
Experimental Cohort 2: 2 through 4 years of age |
20vPnC |
|
|
Experimental Cohort 3: 5 through 9 years of age |
20vPnC |
|
|
Experimental Cohort 4: 10 through 17 years of age |
20vPnC |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer