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Could an extra flu shot shield vulnerable kids?

NCT ID NCT03277703

Prevention Sponsor: Stony Brook 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether giving children with autoimmune diseases (like inflammatory bowel disease or rheumatologic conditions) an extra booster dose of the flu vaccine improves their immune response compared to a single dose. These children take immunosuppressive medications that may weaken vaccine effectiveness. The study will compare flu antibody levels and flu illness rates between children receiving one or two doses, with all participants receiving two doses in the second year.

What this could mean

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

Active substance
Influenza vaccine (booster dose strategy)
What this could lead to
If effective, a booster flu shot could offer stronger protection against flu for children with autoimmune conditions who are on immunosuppressive therapies.
What could go wrong
The trial is small and early, and the immune response may still be weaker than in healthy children. There is also a risk of side effects from the extra vaccine dose.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Nov 2017

Finished

Dec 2019

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.

Ages

3 to 22 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 ages 3-22 years * Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows: * TNF inhibitors \[etanercept (Enbrel), adalimumab (Humira®), infliximab (Remicade®)\] * anti IL -1 \[anakinra (Kineret®) or canakinumab (Ilaris®)\] * IL-6 tocilizumab (Actemra®) * anti IL-12/23 ustekinumab (Stelara®) * anti CTLA-4 \[abatacept (Orencia®)\] * vedolizumab (Entyvio®) * azathioprine (Imuran®) * 6 mercaptopurine (Purinethol®) * Cyclosporine * Leflunomide * Mycophenolate * methotrexate (Otrexup® or Rasuvo®) Exclusion Criteria: * Prior allergic reaction to any vaccine components * Other contraindication to influenza vaccination * Severe egg allergy * Pregnancy * Prior Guillain-Barre syndrome * Therapy with oral corticosteroids ≥2 mg/mg/day within 4 weeks of study entry * Prior rituximab * Prior cyclophosphamide * Prior IVIG within 8 weeks * Acute febrile illness at time of study evaluation * No prior history of two doses of influenza in the past for ages 3-8 years

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Conditions

The condition(s) this trial relates to.

Collagen Diseases Crohn disease inflammatory bowel disease rheumatic disorder type III hypersensitivity disease ulcerative colitis influenza prevention target

As listed by the trial registrant

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

Immune complex diseases Inflammatory bowel diseases Rheumatologic disorder

Contacts and locations

Locations

  • Clinical Research Center

    East Setauket, New York, 11733, United States

More trials for these conditions

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