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OpenTrials
Completed

NCT Number: NCT05157191

Safety of Pediatric COVID-19 Vaccination

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.

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Key information

Conditions

Pain Adverse Drug Event Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Extravasation of Diagnostic and Therapeutic Materials Injection Site Reaction Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Northern California, Oakland, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. Number of participants with defined local or systemic reactogenicity events after each dose of COVID-19 vaccine

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe

  2. Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event

  3. Number of participants with at least one moderate-to-severe (Grade 2-3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event

  4. Number of participants with an unsolicited adverse events after each dose of COVID-19 vaccine

    Time frame: Up to 7 days post-vaccination

    The number and percent and descriptions of unsolicited adverse events observed

  5. Number of participants with an adverse event of special interest

    Time frame: Up to 29 days post-vaccination

    The number and percent of individuals with an adverse event of special interest after dose 2 of COVID-19 vaccine

  6. The number and percent of participants with at least one serious adverse event after dose 2 of COVID-19 vaccine

    Time frame: Up to 29 days post-vaccination

    The number and percent of serious adverse events observed and description of each event

Secondary outcomes

  1. Number of participants with defined local or systemic reactogenicity events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe

  2. Number of participants with defined local or systemic reactogenicity events after receiving each dose of COVID-19 vaccine without other vaccines

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe

  3. Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after other routinely recommended vaccines with each dose of COVID-19 vaccine

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each moderate to severe (Grade 2-3) solicited local and systemic reactogenicity event

  4. Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after receiving COVID-19 vaccine without receiving other vaccines

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event

  5. Number of participants with at least one moderate-to-severe (Grade 2-3) solicited local or systemic reactogenicity event after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event

  6. Number of participants with at least one moderate-to-severe (Grade 2-3) solicited local or systemic reactogenicity event after receiving COVID-19 vaccine without receiving other vaccines

    Time frame: Up to 7 days post-vaccination

    Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event

  7. Number of participants with an unsolicited adverse events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine

    Time frame: Up to 7 days post-vaccination

    The number and percent and descriptions of unsolicited adverse events observed

  8. Number of participants with an unsolicited adverse events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine without receiving other vaccines

    Time frame: Up to 7 days post-vaccination

    The number and percent and descriptions of unsolicited adverse events observed

  9. Number of participants with an adverse event of special interest who received other routinely recommended vaccines with each dose of COVID-19 vaccine

    Time frame: Up to 29 days post-vaccination

    The number and percent of individuals who had at least one adverse event of special interest

  10. Number of participants with an adverse event of special interest who received other routinely recommended vaccines with each dose of COVID-19 vaccine without receiving other vaccines

    Time frame: Up to 29 days post-vaccination

    The number and percent of individuals who had at least one adverse event of special interest

  11. The number and percent of participants with at least one serious adverse event who received other routinely recommended vaccines after dose 2 of COVID-19 vaccine

    Time frame: Up to 29 days post-vaccination

    The number and percent of serious adverse events observed and description of each event

  12. The number and percent of participants with at least one serious adverse event who received other routinely recommended vaccines after dose 2 of COVID-19 vaccine without receiving other vaccines

    Time frame: Up to 29 days post-vaccination

    The number and percent of serious adverse events observed and description of each event

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Children's Hospital Medical Center, Cincinnati
  • Columbia University
  • Kaiser Permanente

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2021
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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