Status:
COMPLETED
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
42-98 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
Eligibility Criteria
Inclusion
- 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
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- Major known congenital malformation or serious chronic disorder.
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
1511 Patients enrolled
Trial Details
Trial ID
NCT04379713
Start Date
May 21 2020
End Date
August 31 2022
Last Update
June 13 2023
Active Locations (97)
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1
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
2
Good Samaritan Family Health Team
Fullerton, California, United States, 92831
3
FocilMed
Oxnard, California, United States, 93030
4
Superior Research, LLC
Sacramento, California, United States, 95831