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Safety of Pediatric COVID-19 Vaccination

NCT05157191 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 299

Last updated 2024-11-01

No results posted yet for this study

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

OTHER

Observational

Observational

Sponsors & Collaborators

Principal Investigators

  • Michael J Smith, MD · Duke University

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2023-05-25
Completion
2023-10-27

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05157191 on ClinicalTrials.gov