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Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children

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: NCT06038617
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : November 2, 2023
Sponsor:
Collaborators:
Kaiser Permanente
Columbia University
Children's Hospital Medical Center, Cincinnati
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2).

Condition or disease Intervention/treatment Phase
Fever After Vaccination Fever Seizures Fever Biological: mRNA COVID-19 Vaccine Biological: Routine Childhood Vaccinations Phase 4

Detailed Description:
Parent(s) or legal authorized representative(s) (LAR) will assess fever and other solicited systemic adverse events on the day of vaccination (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period. Parental/LAR perceptions about their child's vaccine schedule will be assessed on Day 7 following Visit 2.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Open-label Clinical Trial to Assess the Safety of Simultaneous Vaccination With mRNA COVID-19 Vaccine and Other Vaccines in Young Children Aged 6 Months to <5 Years.
Actual Study Start Date : October 30, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Simultaneous vaccination arm
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
 Biological: mRNA COVID-19 Vaccine
ACIP Recommended Vaccine
Other Name: Pfizer COVID-19 Vaccine, Moderna COVID-19 Vaccine

Biological: Routine Childhood Vaccinations
ACIP Recommended Vaccines
Other Name: Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines
Experimental: Sequential vaccination arm
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
 Biological: mRNA COVID-19 Vaccine
ACIP Recommended Vaccine
Other Name: Pfizer COVID-19 Vaccine, Moderna COVID-19 Vaccine

Biological: Routine Childhood Vaccinations
ACIP Recommended Vaccines
Other Name: Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Fever Following Vaccination [ Time Frame: 2 Days Post-Administration ]
    Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.


Secondary Outcome Measures :
  1. Number of Participants with Fever Following Visit 1 [ Time Frame: 2 Days Post Administration ]
    Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1

  2. Number of Participants with Fever Following Visit 2 [ Time Frame: 2 Days Post Administration ]
    Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2

  3. Number of Participants with Grade 2 and/or 3 Fever Following Visit 1 [ Time Frame: 2 Days Post Administration ]
    Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)

  4. Number of Participants with Grade 2 and/or 3 Fever Following Visit 2 [ Time Frame: 2 Days Post Administration ]
    Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)

  5. Number of Participants with Grade 2 and/or 3 Fever Following Visit 1 and Visit 2 Combined [ Time Frame: 2 Days Post Administration ]
    Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)

  6. Number of Participants with Medical Care Utilization - Visit 1 [ Time Frame: 2 Days Post Administration ]
    Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 1.

  7. Number of Participants with Medical Care Utilization - Visit 2 [ Time Frame: 2 Days Post Administration ]
    Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 2.

  8. Number of Participants with Medical Care Utilization - Visit 1 and Visit 2 Combined [ Time Frame: 2 Days Post Administration ]
    Number of children with medical care utilization (medical advice (telephone, patient portal), urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and /or day 2 following Visit 1 and Visit 2 combined.

  9. Number of Participants who Received Antipyretics - Visit 1 [ Time Frame: 2 Days Post Administration ]
    Number of children who received antipyretics on day 1 and/or day 2 following Visit 1.

  10. Number of Participants who Received Antipyretics - Visit 2 [ Time Frame: 2 Days Post Administration ]
    Number of children who received antipyretics on day 1 and/or day 2 following Visit 2.

  11. Number of Participants who Received Antipyretics - Visit 1 and Visit 2 Combined [ Time Frame: 2 Days Post Administration ]
    Number of children who received antipyretics on day 1 and/or day 2 following Visit 1 and Visit 2 combined.

  12. Number of Participants with Defined Systemic Reactogenicity Events [ Time Frame: Up to 7 Days Post Administration ]
    Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe

  13. The Number and Percent of Individuals with At Least One Serious Adverse Event [ Time Frame: Up to 105 Days Post Administration ]
    The number and percent of serious adverse events observed and description of each event


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child 6 months through <5 years of age at time of enrollment.
  • Child is due to receive mRNA COVID-19 vaccine and at least one other routinely recommended non-live vaccine per CDC or ACIP recommendations.
  • Parental/LAR intention of child receiving mRNA COVID-19 vaccine and at least one recommended non-live vaccine.
  • The parent/LAR must be willing and capable of providing permission for their child to participate through the written informed consent process.
  • The parent/LAR must be available for follow-up and must at minimum have telephone access.
  • The parent/LAR must agree to sign a medical release for the child so that study personnel may obtain medical information about the child's health (if needed).
  • The parent/LAR must be willing to delay COVID-19 vaccination for their child for up to 3 weeks.
  • The parent/LAR must be able to read English or Spanish.

Exclusion Criteria:

  • History of any seizure (including febrile seizure) or first degree relative (biologic parent or biologic sibling including half-sibling) with a history of febrile seizure.
  • Contraindication to mRNA COVID-19 vaccine: A history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine or a known diagnosed allergy to a component of COVID-19 vaccine.
  • A history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of a vaccine administered on the day of study enrollment.
  • For children receiving DTaP vaccine (alone or combination vaccine): Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTP or DTaP.
  • Received any other non-live vaccines within 14 days prior to enrollment or any other live vaccines within 28 days prior to enrollment.
  • Intention to receive non-COVID-19 non-live or live vaccines during the 4 weeks after Visit 1; vaccines may be administered after enrollment if deemed a personal or public health priority by the health care provider caring for this patient or the study team.
  • Received prior COVID-19 vaccine as part of a clinical trial.
  • Received any experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to enrollment in this study or expects to receive an experimental/investigational agent during the study.
  • A moderate to severe acute illness and/or a reported temperature ≥ 100.4°F (≥38.0°C) within 48 hours prior to enrollment or a temperature (measured by temporal artery thermometer) ≥100.4°F (≥38.0°C) at the time of enrollment. (This may result in a temporary delay of vaccination).
  • Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours prior to enrollment (this may result in a temporary delay of vaccination) or planned receipt of a prophylactic antipyretic medication on the day of and/or days following vaccination prior to any measured increase in temperature in anticipation of a fever (this exclusion does not apply if the Parent/LAR indicates they might administer antipyretics or analgesics after vaccination to reduce a fever or pain).
  • Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy since birth.
  • Long term (at least 14 days of prednisone 2 mg/kg/day or equivalent other glucocorticoid) use of any parenteral steroids or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the 6 months prior to enrollment (topical and nasal steroids are allowed).
  • Has an active case of COVID-19 infection.
  • History of multisystem inflammatory syndrome (MIS-C).
  • History of myocarditis or pericarditis.
  • Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
  • Any child or grandchild of a study investigator or study team member.
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): NCT06038617


Contacts
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Contact: Michael J Smith, MD 919-684-6335 michael.j.smith@duke.edu
Contact: Emily A Randolph, MBA 919-353-5785 emily.randolph@duke.edu

Locations
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United States, California
Kaiser Permanente Northern California Not yet recruiting
Oakland, California, United States, 94612
Contact: Nicola Klein, MD    510-267-7540    nicola.klein@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 Not yet recruiting
New York, New York, United States, 10027
Contact: Melissa Stockwell, MD    212-342-5732    mss2112@cumc.columbia.edu   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael J Smith, MD    919-684-6335    michael.j.smith@duke.edu   
Contact: Emily A Randolph, MBA    919-385-5785    emily.randolph@duke.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Not yet 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
Kaiser Permanente
Columbia University
Children's Hospital Medical Center, Cincinnati
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Michael J Smith, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT06038617    
Other Study ID Numbers: Pro00113014
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: November 2, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Duke University:
COVID vaccine
Fever following vaccination
Additional relevant MeSH terms:
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Seizures
Fever
Hyperthermia
Neurologic Manifestations
Nervous System Diseases
Body Temperature Changes
 Heat Stress Disorders
Wounds and Injuries
Vaccines
Immunologic Factors
Physiological Effects of Drugs