Safety of Pediatric COVID-19 Vaccination

Duke University

Status: Completed

Conditions: Adverse Drug Event; Injection Site Reaction; Pain

Treatments: Other: Observational

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05157191

Pro00110056

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Children ≥ 5 years to < 16 years of age
2. Receiving first dose or a booster dose of a U.S authorized or approved and recommended COVID-19 vaccine per standard of care
3. Parent/legal authorized representative (LAR) willing to provide written informed consent per local IRB requirements
4. Participant willing to provide assent per local IRB requirements
5. Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls
6. English or Spanish literate.

Exclusion criteria

1. Current or planned participation in any clinical trial with an investigational product during the study period.*

   • Per protocol, co-enrollment in observational or behavioral intervention studies are permitted at any time. An investigational product or behavioral intervention permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period (e.g., COVID-19 illness)

2. Any condition, which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.

3. Anyone who is a relative of any research study personnel or is an employee supervised by study staff.

Trial design

299 participants in 1 patient group

mRNA COVID-19 vaccine

Description:

Children and adolescents (ages ≥ 5 to \< 16) who receive mRNA COVID-19 vaccine per standard of care

Treatment:

Other: Observational