Safety of Pediatric COVID-19 Vaccination

Study Overview
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Brief Summary
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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.

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

Conditions
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Adverse Drug Event, Pain, Injection Site Reaction

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mRNA COVID-19 vaccine<br>Children and adolescents (ages ≥ 5 to < 16) who receive mRNA COVID-19 vaccine per standard of care | Other: Observational<br>* Observational<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 vaccine, fever following vaccination, pain following vaccination