Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
42-98 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs in infants when compared to the pneumococcal vacc...
Eligibility Criteria
Inclusion
- 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
- 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, or planned receipt through study participation.
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT06524414
Start Date
July 25 2024
End Date
May 1 2027
Last Update
September 8 2025
Active Locations (62)
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1
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States, 72703
2
The Children's Clinic
Jonesboro, Arkansas, United States, 72401
3
Los Ninos Children's Medical Clinic
La Puente, California, United States, 91744
4
Stanford University Medical Center
Palo Alto, California, United States, 94304