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New study tracks COVID-19 vaccine side effects in kids ages 5 to 16

NCT ID NCT05157191

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study follows children and adolescents aged 5 to 16 who receive an mRNA COVID-19 vaccine to monitor for side effects like injection site pain, fever, and other reactions. Participants report symptoms for a week after each dose, and some provide blood samples to measure antibody levels. The goal is to better understand the safety and immune response of COVID-19 vaccines in younger populations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA COVID-19 vaccine
What this could lead to
If successful, this study could provide clear safety data on COVID-19 vaccines in children, helping guide vaccination recommendations.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all children or vaccine types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

299 people

The number who actually took part.

Started

Apr 2022

Finished

Oct 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

320 healthy male or female ≥ 5 years to \< 16 years of age

Ages

5 to 15 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Children ≥ 5 years to \< 16 years of age 2. Receiving first dose or a booster dose of a U.S authorized or approved and recommended COVID-19 vaccine per standard of care 3. Parent/legal authorized representative (LAR) willing to provide written informed consent per local IRB requirements 4. Participant willing to provide assent per local IRB requirements 5. Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls 6. English or Spanish literate. Exclusion Criteria: 1. Current or planned participation in any clinical trial with an investigational product during the study period.\* * Per protocol, co-enrollment in observational or behavioral intervention studies are permitted at any time. An investigational product or behavioral intervention permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period (e.g., COVID-19 illness) 2. Any condition, which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives. 3. Anyone who is a relative of any research study personnel or is an employee supervised by study staff.

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Conditions

The condition(s) this trial relates to.

Drug-Related Side Effects and Adverse Reactions Injection Site Reaction Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adverse drug event Injection site reaction Pain

Contacts and locations

Locations

  • Centers for Disease Control and Prevention

    Atlanta, Georgia, 30333, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Columbia University

    New York, New York, 10027, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Kaiser Permanente Northern California

    Oakland, California, 94612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.