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Super flu shot for middle-aged adults? new study shows promise

NCT ID NCT06641180

Prevention Sponsor: Sanofi Pasteur, a Sanofi Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a high-dose flu vaccine works better than the standard dose in adults aged 50 to 64. About 1,180 participants received either the high-dose or standard-dose shot, and researchers measured their immune response 28 days later. The goal is to see if the stronger dose provides better protection against the flu for this age group.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,180 people

The number who actually took part.

Started

Nov 2024

Finished

Jun 2025

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

50 to 64 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: * Aged 50 to 64 years on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile. OR * Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration. * A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) at enrollment before the first dose of study intervention. * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all study procedures. Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Personal or family history of Guillain-Barré Syndrome (GBS). * Known systemic hypersensitivity to any of the study intervention components (Section 1.1, Section 6.1), or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances. * Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment. * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion. * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. * Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine prior to the second blood drawing (ie. approximately 4 weeks after the study intervention administration). * Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine. * Receipt of immune globulins, blood, or blood-derived products in the past 3 months. * Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily. * 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 (ie. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

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

Influenza

Contacts and locations

Locations

  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400019

    Fort Myers, Florida, 33912, United States

  • Alliance for Multispeciality Research - Lexington- Site Number : 8400002

    Lexington, Kentucky, 40509, United States

  • Alliance for Multispeciality Research - Newton- Site Number : 8400003

    Newton, Kansas, 67114, United States

  • Alliance for Multispecialty Research - Volunteer Research Group- Site Number : 8400001

    Knoxville, Tennessee, 37920, United States

  • Aventiv Research Columbus- Site Number : 8400016

    Columbus, Ohio, 43213, United States

  • CBH Health - Gaithersburg- Site Number : 8400004

    Gaithersburg, Maryland, 20877, United States

  • CenExel CNS- Site Number : 8400005

    Los Alamitos, California, 90720, United States

  • Cenexel IRA - iResearch Atlanta- Site Number : 8400007

    Decatur, Georgia, 30030, United States

  • Cenexel IRS - iResearch Savannah- Site Number : 8400008

    Savannah, Georgia, 31405, United States

  • Centricity Morehead- Site Number : 8400014

    Morehead City, North Carolina, 28557, United States

  • Centricity New Bern- Site Number : 8400015

    New Bern, North Carolina, 28562, United States

  • Centricity Research - Rincon- Site Number : 8400012

    Rincon, Georgia, 31406, United States

  • Centricity Research - Suffolk Primary Care - Centricity - PPDS- Site Number : 8400013

    Suffolk, Virginia, 23435-3763, United States

  • Hassman Research Institute - Berlin- Site Number : 8400006

    Berlin, New Jersey, 08009, United States

  • IACT Health - Columbus - Talbotton Road- Site Number : 8400011

    Columbus, Georgia, 31904, United States

  • JBR Clinical Research- Site Number : 8400009

    Salt Lake City, Utah, 84107, United States

  • Kaiser Permanente Center for Health Research- Site Number : 8400018

    Portland, Oregon, 97227, United States

  • Kaiser Permanente Washington- Site Number : 8400024

    Seattle, Washington, 98101, United States

  • Research Centers of America - Hollywood- Site Number : 8400010

    Hollywood, Florida, 33024, United States

  • The Hope Clinic of Emory Vaccine Center- Site Number : 8400017

    Decatur, Georgia, 30030, United States

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