Clinical trial NCT05157191: Safety of Pediatric COVID-19 Vaccination
Official title: A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Injection Site Reaction
Adverse Drug Event
Keywords: COVID-19 vaccine
fever following vaccination
pain following vaccination
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Kaiser Permanente
name: Columbia University
name: Children's Hospital Medical Center, Cincinnati
First posted: 2021-12-14
Enrollment: 299
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 320 healthy male or female ≥ 5 years to \< 16 years of age

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with defined local or systemic reactogenicity events after each dose of COVID-19 vaccine
timeFrame: Up to 7 days post-vaccination
measure: Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine
timeFrame: Up to 7 days post-vaccination
measure: 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
timeFrame: Up to 7 days post-vaccination
measure: Number of participants with an unsolicited adverse events after each dose of COVID-19 vaccine
timeFrame: Up to 7 days post-vaccination
measure: Number of participants with an adverse event of special interest
timeFrame: Up to 29 days post-vaccination
measure: The number and percent of participants with at least one serious adverse event after dose 2 of COVID-19 vaccine
timeFrame: Up to 29 days post-vaccination
Secondary outcomes:
measure: Number of participants with defined local or systemic reactogenicity events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine
timeFrame: Up to 7 days post-vaccination
measure: Number of participants with defined local or systemic reactogenicity events after receiving each dose of COVID-19 vaccine without other vaccines
timeFrame: Up to 7 days post-vaccination
measure: 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
timeFrame: Up to 7 days post-vaccination
measure: 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
timeFrame: Up to 7 days post-vaccination
measure: 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
timeFrame: Up to 7 days post-vaccination
measure: 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
timeFrame: Up to 7 days post-vaccination
measure: Number of participants with an unsolicited adverse events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine
timeFrame: Up to 7 days post-vaccination
measure: 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
timeFrame: Up to 7 days post-vaccination
measure: Number of participants with an adverse event of special interest who received other routinely recommended vaccines with each dose of COVID-19 vaccine
timeFrame: Up to 29 days post-vaccination
measure: 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
timeFrame: Up to 29 days post-vaccination
measure: 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
timeFrame: Up to 29 days post-vaccination
measure: 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
timeFrame: Up to 29 days post-vaccination
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Atlanta
country: United States
facility: Centers for Disease Control and Prevention
state: Georgia
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Duke University
name: Michael J Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: