Evaluating the safety of simultaneous COVID-19 and childhood vaccinations 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.

This study is testing if giving the COVID-19 vaccine at the same time as other routine childhood vaccines is safe for kids aged 6 months to under 5 years.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 6 Months to 4 Years
• Sex: All
• Sponsor: Duke University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 5 sites (Oakland, California and 4 other locations)
• Trial ID: NCT06038617 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety of administering the mRNA COVID-19 vaccine alongside other routine childhood vaccinations in children aged 6 months to under 5 years. Participants will be randomly assigned to receive both vaccines simultaneously or sequentially at separate visits. Parents or legal representatives will monitor and report any fever or adverse events for a week following vaccination. The study aims to gather data on the safety profile of simultaneous vaccinations compared to the traditional approach.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 months to under 5 years who are due for the mRNA COVID-19 vaccine and at least one other recommended non-live vaccine.

Not a fit: Patients with a history of seizures or febrile seizures, or those with a first-degree relative who has experienced seizures, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence supporting the safe co-administration of COVID-19 and routine childhood vaccines, potentially improving vaccination rates.

How similar studies have performed: Other studies have explored the safety of simultaneous vaccinations, but this specific approach to combining COVID-19 and routine childhood vaccines is relatively novel.

Eligibility 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.

Where this trial is running

Oakland, California and 4 other locations

• Kaiser Permanente Northern California — Oakland, California, United States (Recruiting)
• Centers for Disease Control and Prevention — Atlanta, Georgia, United States (Active_not_recruiting)
• Columbia University — New York, New York, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Michael J Smith, MD — Duke University
• Study coordinator: Michael J Smith, MD

Conditions Fever After Vaccination; Fever; Seizures Fever; COVID vaccine; Fever following vaccination