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Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children | Clinical Trials | Clareo Health

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

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.

NCT06038617•Duke University

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

0 - 4 years

Sex

ALL

Healthy Volunteers

Yes

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).
+7 more criteria

Locations (5)

Kaiser Permanente Northern California

Oakland, California, United States

Centers for Disease Control and Prevention

Atlanta, Georgia, United States

Columbia University

New York, New York, United States

Duke University

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

October 30, 2023

Primary Completion Date

April 24, 2025

Completion Date

July 25, 2025

Last Updated

September 9, 2025

Enrollment

344

ACTUAL participants

Conditions

Fever After VaccinationFeverSeizures Fever

Interventions

mRNA COVID-19 Vaccine

BIOLOGICAL

Routine Childhood Vaccinations

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population

VAC-SIP-YF (Vaccination- Safety & Immunogenicity During Pregnancy- Yellow Fever)

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

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