Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About How a New Pneumococcal Vaccine Works in Children
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
12-15 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 month...
Eligibility Criteria
Inclusion
- Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- Have received 3 infant doses of 20vPnC with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
Exclusion
- 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 and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2026
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06531538
Start Date
July 30 2024
End Date
February 16 2026
Last Update
July 3 2025
Active Locations (47)
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1
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States, 20009
2
Bio-Medical Research LLC
Miami, Florida, United States, 33144
3
Riveldi Biomedical Research and Associates - Miami Lakes
Miami Lakes, Florida, United States, 33014
4
Tekton Research, LLC.
Chamblee, Georgia, United States, 30341