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Safety of Pediatric COVID-19 Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05157191
Recruitment Status : Recruiting
First Posted : December 14, 2021
Last Update Posted : December 5, 2022
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Kaiser Permanente
Columbia University
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Duke University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Pain Injection Site Reaction Adverse Drug Event Other: Observational

Study Design
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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Children and Adolescents
Actual Study Start Date : April 6, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with defined local or systemic reactogenicity events after each dose of COVID-19 vaccine [ Time Frame: 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

  2. Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine [ Time Frame: Up to 7 days post-vaccination ]
    Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event

  3. 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 [ Time Frame: Up to 7 days post-vaccination ]
    Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event

  4. Number of participants with an unsolicited adverse events after each dose of COVID-19 vaccine [ Time Frame: Up to 7 days post-vaccination ]
    The number and percent and descriptions of unsolicited adverse events observed

  5. Number of participants with an adverse event of special interest [ Time Frame: 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

  6. The number and percent of participants with at least one serious adverse event after dose 2 of COVID-19 vaccine [ Time Frame: Up to 29 days post-vaccination ]
    The number and percent of serious adverse events observed and description of each event


Secondary Outcome Measures :
  1. Number of participants with defined local or systemic reactogenicity events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine [ Time Frame: 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

  2. Number of participants with defined local or systemic reactogenicity events after receiving each dose of COVID-19 vaccine without other vaccines [ Time Frame: 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

  3. 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 [ Time Frame: Up to 7 days post-vaccination ]
    Tables summarizing each moderate to severe (Grade 2-3) solicited local and systemic reactogenicity event

  4. 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 [ Time Frame: Up to 7 days post-vaccination ]
    Tables summarizing each severe (Grade 3) solicited local and systemic reactogenicity event

  5. 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 [ Time Frame: Up to 7 days post-vaccination ]
    Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event

  6. 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 [ Time Frame: Up to 7 days post-vaccination ]
    Tables summarizing each moderate-to-severe (Grade 2-3) solicited local and systemic reactogenicity event

  7. Number of participants with an unsolicited adverse events after receiving other routinely recommended vaccines with each dose of COVID-19 vaccine [ Time Frame: Up to 7 days post-vaccination ]
    The number and percent and descriptions of unsolicited adverse events observed

  8. 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 [ Time Frame: Up to 7 days post-vaccination ]
    The number and percent and descriptions of unsolicited adverse events observed

  9. Number of participants with an adverse event of special interest who received other routinely recommended vaccines with each dose of COVID-19 vaccine [ Time Frame: Up to 29 days post-vaccination ]
    The number and percent of individuals who had at least one adverse event of special interest

  10. 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 [ Time Frame: Up to 29 days post-vaccination ]
    The number and percent of individuals who had at least one adverse event of special interest

  11. 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 [ Time Frame: Up to 29 days post-vaccination ]
    The number and percent of serious adverse events observed and description of each event

  12. 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 [ Time Frame: Up to 29 days post-vaccination ]
    The number and percent of serious adverse events observed and description of each event


Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
320 healthy male or female ≥ 5 years to < 16 years of age
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05157191


Contacts
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Contact: Michael J Smith, MD 919 684 6335 michael.j.smith@duke.edu
Contact: Emily A Randolph 919 385-5785 emily.randolph@duke.edu

Locations
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United States, California
Kaiser Permanente Northern California Recruiting
Oakland, California, United States, 94612
Contact: Nicola Klein, MD    510-267-7540    nicola.klein@kp.org   
Contact: Laurie Aukes, RN    510-432-5845    laurie.a.aukes@kp.org   
United States, Georgia
Centers for Disease Control and Prevention Active, not recruiting
Atlanta, Georgia, United States, 30333
United States, New York
Columbia University Recruiting
New York, New York, United States, 10027
Contact: Melissa Stockwell, MD    212-342-5732    mss2112@cumc.columbia.edu   
Contact: Philip LaRussa, MD    914-552-1305    psl1@cumc.columbia.edu   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Mike Smith, MD    919-684-6335    michael.j.smith@duke.edu   
Contact: Emily Randolph    919-385-5785    emily.randolph@duke.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Elizabeth Schlaudecker, MD    513-803-0747    elizabeth.schlaudecker@ccmc.org   
Contact: Mary Staat, MD    513-636-2877    mary.staat@cchmc.org   
Sponsors and Collaborators
Duke University
Centers for Disease Control and Prevention
Kaiser Permanente
Columbia University
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Michael J Smith, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol  [PDF] April 18, 2022

More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05157191    
Other Study ID Numbers: Pro00110056
First Posted: December 14, 2021    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
COVID-19 vaccine
fever following vaccination
pain following vaccination
Additional relevant MeSH terms:
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COVID-19
Injection Site Reaction
Drug-Related Side Effects and Adverse Reactions
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Chemically-Induced Disorders
Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes