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Your flu shot could help design next Year's vaccine

NCT ID NCT04109222

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study collected blood samples from 90 children (6 months to under 9 years) and adults 65 and older after they received the 2019-2020 flu vaccine. The samples were sent to health agencies like the WHO and CDC to help them decide which flu strains to include in future vaccines. The study did not test a new treatment or cure, but aimed to improve vaccine recommendations.

What this could mean

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

Active substance
Fluzone Quadrivalent and Fluzone High-Dose influenza vaccines
What this could lead to
If successful, this study could help health experts choose the right flu vaccine formula for future seasons, potentially making flu shots more effective.
What could go wrong
This is a small, completed sample-collection study, not a test of vaccine effectiveness. The results may not directly improve vaccines or protect against flu.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

90 people

The number who actually took part.

Started

Sep 2019

Finished

Dec 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

6 months to 83 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 : An individual who fulfilled all of the following criteria were eligible for study enrollment: * Aged 6 months to \< 9 years or \>= 65 years of age on the day of first study vaccination (study product administration). * For participants 6 to \< 12 months of age, born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 5.5 pounds (2.5 kilograms). * Informed consent form (ICF) had been signed and dated by participants \>= 65 years of age. * Assent form had been signed and dated by participants 7 to \< 9 years of age, and ICF had been signed and dated by parent(s) or guardian(s) for participants 6 months to \< 9 years of age. * Participant and parent/guardian (of participants 6 months to \< 9 years of age) were able to attend all scheduled visits and complied with all study procedures. Exclusion criteria: An individual who fulfilled any of the following criteria were excluded from study enrollment: * Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine. * Previous vaccination against influenza (in the 2019-2020 influenza season) with either study vaccine or another vaccine. * Receipt of immune globulins, blood, or blood-derived products in the 3 months preceding planned inclusion. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the 6 months preceding planned inclusion; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the 3 months preceding planned inclusion). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to study vaccine or to a vaccine containing any of the same substances. * Thrombocytopenia, which might be a contraindication for intramuscular vaccination, at the discretion of the Investigator. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of planned vaccination or febrile illness (temperature \>= 100.4 degree (°) Fahrenheit \[38.0 °Celsius\]). A prospective participant were not included in the study until the condition had resolved or the febrile event had subsided. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) or in-laws of the Investigator or employee with direct involvement in the proposed study. * History of serious adverse reaction to any influenza vaccine. * Personal history of Guillain-Barré syndrome. * Any condition that in the opinion of the Investigator would pose a health risk to the participants if enrolled or could interfere with the evaluation of the vaccine. * Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder. * Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Investigational Site Number 8400001

    Salt Lake City, Utah, 84121, United States

  • Investigational Site Number 8400002

    Bardstown, Kentucky, 40004, United States

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