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Mayo clinic study aims to define normal vaccine reactions in kids

NCT ID NCT04112355

Knowledge-focused Sponsor: Mayo Clinic 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study from Mayo Clinic measures how healthy children's immune systems respond to routine vaccines. Researchers will take blood samples before and after vaccination to track levels of various immune markers. The goal is to establish a range of normal responses, which could help identify when a child's immune system is not working properly. The study will also look at whether certain genetic differences affect these responses.

What this could mean

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

What this could lead to
This study could help doctors better understand what a normal immune response to vaccines looks like in healthy children, which may improve care for kids with unusual reactions to infections.
What could go wrong
This is an observational study, not a treatment trial. It only measures responses in healthy children, so results may not apply to sick children or lead to direct medical changes.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Dec 2028

An estimate. End dates often move.

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

Children scheduled for vaccinations at Mayo Clinic in Rochester, MN

Ages

4 months to 21 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: * Children 5-7 months of age receiving the 3rd scheduled dose of the diphtheria, tetanus, pertussis, inactivated polio, Haemophilus influenzae type b, and pneumococcal conjugate vaccine (DTap-IPV/Hib+PCV13). * Children 10-18 months of age receiving the 1st scheduled dose of the measles, mumps, rubella, and varicella vaccine (MMR+VZV). * Children 4-6 years of age receiving the 2nd scheduled MMR+VZV dose. * Children and young adults receiving the annual flu vaccine or COVID vaccine Exclusion Criteria: * History of autoinflammatory or autoimmune disease. * History of genetic or metabolic disorder. * History of hematological disorder. * History of malignancy or active malignancy undergoing suppressive treatment. * Blood donation or collection within 8 weeks of the study. * Signs or symptoms consistent with severe infection at the time of first visit. * Weight less than 6 kg in group 1, less than 7.5 kg for group 2, less than 12 kg for group 3.

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As listed by the trial registrant

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

Healthy controls

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

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