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

NCT06038617 | Completed Phase 4 FDA Drug

• 1 other identifier: Pro00113014
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 5

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).

Conditions

Fever After Vaccination; Fever; Seizures Fever

Keywords

COVID vaccine; Fever following vaccination

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Fever Following Vaccination

  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.

  2 Days Post-Administration

Secondary Outcomes (13)

• Number of Participants with Fever Following Visit 1

  2 Days Post Administration

• Number of Participants with Fever Following Visit 2

  2 Days Post Administration

• Number of Participants with Grade 2 and/or 3 Fever Following Visit 1

  2 Days Post Administration

• Number of Participants with Grade 2 and/or 3 Fever Following Visit 2

  2 Days Post Administration

• Number of Participants with Grade 2 and/or 3 Fever Following Visit 1 and Visit 2 Combined

  2 Days Post Administration

Study Arms (2)

Simultaneous vaccination arm

EXPERIMENTAL

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; Biological: Routine Childhood Vaccinations

Sequential vaccination arm

EXPERIMENTAL

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; Biological: Routine Childhood Vaccinations

Interventions

mRNA COVID-19 Vaccine BIOLOGICAL

ACIP Recommended Vaccine

Also known as: Pfizer COVID-19 Vaccine, Moderna COVID-19 Vaccine

Sequential vaccination arm; Simultaneous vaccination arm

Routine Childhood Vaccinations BIOLOGICAL

ACIP Recommended Vaccines

Also known as: Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines

Sequential vaccination arm; Simultaneous vaccination arm

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Duke University: lead
• Kaiser Permanente: collaborator
• Columbia University: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (5)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Fever; Seizures, Febrile

Interventions

CVnCoV COVID-19 vaccine; BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273; measles, mumps, rubella, varicella vaccine; Hepatitis A Vaccines; Hepatitis B Vaccines; Influenza Vaccines

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Seizures; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; Viral Hepatitis Vaccines

Study Officials

• Michael J Smith, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: October 30, 2023
• Primary Completion: April 24, 2025
• Study Completion: July 25, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)