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Virus Therapy

mRNA COVID-19 Vaccine Safety With Childhood Vaccines

Phase 4

Recruiting

Led By Michael J Smith, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parental/LAR intention of child receiving mRNA COVID-19 vaccine and at least one recommended non-live vaccine

Child 6 months through <5 years of age at time of enrollment

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 105 days post administration

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study if it's safe to give children COVID-19 vaccine and other routine childhood vaccines on the same day or at separate times.

Who is the study for?

This trial is for children aged 6 months to under 5 years who are due for their mRNA COVID-19 vaccine and at least one other non-live routine vaccine. Parents must be willing to delay the COVID-19 shot up to 3 weeks, consent to medical information release, and ensure follow-up. Children with active COVID-19, history of MIS-C, recent or planned experimental treatments, immunosuppression, certain severe allergies or reactions to vaccines are excluded.

What is being tested?

The study tests the safety of giving young children the mRNA COVID-19 vaccine simultaneously with other childhood vaccines compared to spacing them out over separate visits. It's a prospective (looking forward in time), randomized (participants randomly assigned), open-label (no placebo control) trial.

What are the potential side effects?

Potential side effects may include fever, seizures related to high body temperature (febrile seizures), and typical responses seen after vaccinations such as soreness at injection site or mild illness symptoms. The study specifically looks at whether these side effects increase when vaccines are given together.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I intend for my child to receive the mRNA COVID-19 vaccine and another recommended vaccine.

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My child is between 6 months and 5 years old.

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My child is scheduled to receive the mRNA COVID-19 vaccine and another recommended vaccine.

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I, or my legal representative, can read English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I or my close family member had a seizure.

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I am allergic to the COVID-19 vaccine or its components.

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I haven't taken any experimental treatments in the last 28 days.

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I have a weakened immune system due to illness, treatment, or cancer therapy.

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I haven't used high-dose steroids or inhaled steroids above the limit in the last 6 months.

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I currently have COVID-19.

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I have had multisystem inflammatory syndrome.

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My child had a severe brain reaction not caused by something else within 7 days after getting a DTaP shot.

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I have had myocarditis or pericarditis in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 105 days post administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 105 days post administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 105 days post administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Fever Following Vaccination

Secondary study objectives

Number of Participants who Received Antipyretics - Visit 1

Number of Participants who Received Antipyretics - Visit 1 and Visit 2 Combined

Number of Participants who Received Antipyretics - Visit 2

+10 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Simultaneous vaccination armExperimental Treatment2 Interventions

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.

Group II: Sequential vaccination armExperimental Treatment2 Interventions

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.

0 / 13Eligibility criteria met