A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
Trial status:Study Complete
Study Identifier:
C4591007
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Study Complete
Trial details
Medical Condition
Study Drug
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Phase
Phase 2
Sex
Female & Male
Age
6 Months - 15 Years
Estimated Trial Date
Mar 2021 - Oct 2023
Protocol summary
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.
Trial locations
Location
Status
Location
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States, 35233
Status
Location
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Status
Location
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Status
Location
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Status
Location
Matrix Clinical Research
Los Angeles, California, United States, 90057
Status
Location
Madera Family Medical Group
Madera, California, United States, 93637
Status