Safety of Pediatric COVID-19 Vaccination

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05157191
• Other study ID #: Pro00110056
• Status: Completed
• Start date: April 6, 2022
• Est. completion date: October 27, 2023

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: October 27, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Drug Event
• COVID-19
• Drug-Related Side Effects and Adverse Reactions
• Injection Site Reaction
• Pain

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
United States	Centers for Disease Control and Prevention	Atlanta	Georgia
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke University	Durham	North Carolina
United States	Columbia University	New York	New York
United States	Kaiser Permanente Northern California	Oakland	California

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Centers for Disease Control and Prevention, Children's Hospital Medical Center, Cincinnati, Columbia University, Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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