Safety of Pediatric COVID-19 Vaccination

NCT05157191 | Completed

• 1 other identifier: Pro00110056
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

COVID-19 vaccine; fever following vaccination; pain following vaccination

Outcome Measures

Primary Outcomes (6)

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

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

  Up to 7 days post-vaccination

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

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

  Up to 7 days post-vaccination

• 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

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

  Up to 7 days post-vaccination

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

  The number and percent and descriptions of unsolicited adverse events observed

  Up to 7 days post-vaccination

• Number of participants with an adverse event of special interest

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

  Up to 29 days post-vaccination

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

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

  Up to 29 days post-vaccination

Secondary Outcomes (12)

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

  Up to 7 days post-vaccination

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

  Up to 7 days post-vaccination

• 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

  Up to 7 days post-vaccination

• 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

  Up to 7 days post-vaccination

• 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

  Up to 7 days post-vaccination

Study Arms (1)

mRNA COVID-19 vaccine

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

Other: Observational

Interventions

Observational OTHER

Observational

mRNA COVID-19 vaccine

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

320 healthy male or female ≥ 5 years to \< 16 years of age

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Pain; Injection Site Reaction; Drug-Related Side Effects and Adverse Reactions

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Michael J Smith, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 14, 2021
• Study Start: April 6, 2022
• Primary Completion: May 25, 2023
• Study Completion: October 27, 2023
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)