Safety of Pediatric COVID-19 Vaccination

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Adverse Drug Event
COVID-19
Drug-Related Side Effects and Adverse Reactions
Injection Site Reaction
Pain

Clinical Trial Details

NCT number	NCT05157191
Study type	Observational
Source	Duke University
Contact
Status	Completed
Phase
Start date	April 6, 2022
Completion date	October 27, 2023

View Details

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