Safety of Pediatric COVID-19 Vaccination

Completed

• Conditions: Adverse Drug Event; Injection Site Reaction; Pain
• Interventions: Other: Observational

• Registration Number: NCT05157191
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-14
• Study Start: 2022-04-06
• Primary Completion: 2023-05-25
• Study Completion: 2023-10-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants with an unsolicited adverse events after each dose of COVID-19 vaccine	Up to 7 days post-vaccination	The number and percent and descriptions of unsolicited adverse events observed
Number of participants with an adverse event of special interest	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
The number and percent of participants with at least one serious adverse event after dose 2 of COVID-19 vaccine	Up to 29 days post-vaccination	The number and percent of serious adverse events observed and description of each event
Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine	Up to 7 days post-vaccination	Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event
Number of participants with defined local or systemic reactogenicity events after each dose of COVID-19 vaccine	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
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	Up to 7 days post-vaccination	Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event

Secondary Outcome Measures

Name	Time	Method
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	Tables summarizing each moderate to severe (Grade 2-3) solicited local and systemic reactogenicity event
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	Up to 29 days post-vaccination	The number and percent of serious adverse events observed and description of each event
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	Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
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	Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event
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	Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event
Number of participants with an unsolicited adverse events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine	Up to 7 days post-vaccination	The number and percent and descriptions of unsolicited adverse events observed
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	Up to 7 days post-vaccination	The number and percent and descriptions of unsolicited adverse events observed
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	Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
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	Up to 7 days post-vaccination	Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event
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	Up to 29 days post-vaccination	The number and percent of individuals who had at least one adverse event of special interest
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	Up to 29 days post-vaccination	The number and percent of serious adverse events observed and description of each event
Number of participants with an adverse event of special interest who received other routinely recommended vaccines with each dose of COVID-19 vaccine	Up to 29 days post-vaccination	The number and percent of individuals who had at least one adverse event of special interest

Trial Locations

Locations (5)

Kaiser Permanente Northern California; 🇺🇸 Oakland, California, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Columbia University; 🇺🇸 New York, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Centers for Disease Control and Prevention; 🇺🇸 Atlanta, Georgia, United States