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Safety of Pediatric COVID-19 Vaccination
Sponsor: Duke University
Summary
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to \< 16) will be followed post administration of mRNA COVID-19 vaccines. Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the 7 days following each vaccination using either identical web-based or paper diaries, depending on study participant preference. At Duke University, Cincinnati's Children Hospital, and Kaiser Permanente Northern California, serum samples will be collected for optional assessment of antibody titers to COVID-19. Each participant who opts in will have baseline (within 3 days of vaccination) serologies obtained and immunogenicity assessment at 28 (+7) days after each dose. All participants will be followed for 180 days after dose 2 for serious adverse events and adverse events of special interest.
Official title: A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Children and Adolescents
Key Details
Gender
All
Age Range
5 Years - 15 Years
Study Type
OBSERVATIONAL
Enrollment
299
Start Date
2022-04-06
Completion Date
2023-10-27
Last Updated
2026-07-01
Healthy Volunteers
Yes
Interventions
Observational
Observational
Locations (5)
Kaiser Permanente Northern California
Oakland, California, United States
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States