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NCT05157191

Safety of Pediatric COVID-19 Vaccination

Sponsor: Duke University

View on ClinicalTrials.gov

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

OTHER

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