Status:
COMPLETED
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
42-98 years
Phase:
PHASE3
Brief Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
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
- 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
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2022
Estimated Enrollment :
1997 Patients enrolled
Trial Details
Trial ID
NCT04382326
Start Date
May 20 2020
End Date
September 2 2022
Last Update
December 6 2023
Active Locations (110)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
UAB Pediatric Primary Care Clinic at Children's of Alabama
Birmingham, Alabama, United States, 35233
3
Southeastern Pediatric Associates
Dothan, Alabama, United States, 36305
4
MedPharmics, LLC
Phoenix, Arizona, United States, 85015