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Safety of Pediatric COVID-19 Vaccination

CompletedN/A

Sponsor: Duke University

Conditions: Pain, Injection Site Reaction, Adverse Drug Event

Interventions: Observational

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 5 Years to 15 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (5)

Oakland, California, United States
Atlanta, Georgia, United States
New York, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States