Safety of Pediatric COVID-19 Vaccination

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Adverse Drug Event; Injection Site Reaction
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Actual): 299

Contacts and Locations

• Study Contact: Name: Michael J Smith, MD; Phone Number: 919 684 6335; Email: michael.j.smith@duke.edu
• Study Contact Backup: Name: Emily A Randolph; Phone Number: 919 385-5785; Email: emily.randolph@duke.edu

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California
  • Georgia
    • Atlanta, Georgia, United States, 30333
      • Centers for Disease Control and Prevention
  • New York
    • New York, New York, United States, 10027
      • Columbia University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mRNA COVID-19 vaccine; Children and adolescents (ages ≥ 5 to < 16) who receive mRNA COVID-19 vaccine per standard of care	Other: Observational; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with defined local or systemic reactogenicity events after receiving other routinely recommended vaccines with 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 defined local or systemic reactogenicity events after receiving each dose of COVID-19 vaccine without other vaccines	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 other routinely recommended vaccines with 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 at least one severe (Grade 3) solicited local or systemic reactogenicity event after receiving COVID-19 vaccine without receiving other vaccines	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 receiving other routinely recommended vaccines with 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 at least one moderate-to-severe (Grade 2-3) solicited local or systemic reactogenicity event after receiving COVID-19 vaccine without receiving other vaccines	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 receiving other routinely recommended vaccines with 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 unsolicited adverse events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine without receiving other vaccines	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 who received other routinely recommended vaccines with each dose of COVID-19 vaccine	The number and percent of individuals who had at least one adverse event of special interest	Up to 29 days post-vaccination
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	The number and percent of individuals who had at least one adverse event of special interest	Up to 29 days post-vaccination
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	The number and percent of serious adverse events observed and description of each event	Up to 29 days post-vaccination
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	The number and percent of serious adverse events observed and description of each event	Up to 29 days post-vaccination

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Columbia University; Centers for Disease Control and Prevention; Children's Hospital Medical Center, Cincinnati; Kaiser Permanente
• Investigators: Principal Investigator: Michael J Smith, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19 vaccine; fever following vaccination; pain following vaccination
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Extravasation of Diagnostic and Therapeutic Materials; COVID-19; Drug-Related Side Effects and Adverse Reactions; Injection Site Reaction
• Other Study ID Numbers: Pro00110056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No