NCT05157191

Safety of Pediatric COVID-19 Vaccination

A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Children and Adolescents

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 299 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain
• Injection Site Reaction
• Adverse Drug Event

Interventions

Type	Name	Description
OTHER	Observational	Observational

Timeline

• Start date: 2022-04-06
• Primary completion: 2023-05-25
• Completion: 2023-10-27
• First posted: 2021-12-14
• Last updated: 2024-11-01

Locations

5 sites across 1 country: United States