Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Supercharged flu vaccine shows promise for seniors

NCT ID NCT04024228

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether a high-dose flu vaccine (QIV-HD) works better than the standard-dose vaccine in adults aged 60 and older. Over 1,500 healthy volunteers received either the high-dose or standard shot. Researchers measured immune responses 28 days later to see if the high-dose version triggers stronger protection against four flu strains.

What this could mean

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

Active substance
High-dose quadrivalent influenza vaccine (QIV-HD)
What this could lead to
If successful, this could provide better flu protection for older adults, who are at higher risk of severe illness.
What could go wrong
This is a completed phase 3 trial, but results may show only modest improvement over standard vaccine, and individual responses vary.

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

1,539 people

The number who actually took part.

Started

Oct 2019

Finished

Jun 2020

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

60 years and older

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 : * Sixty years of age and older on the day of inclusion. * Able to attend all scheduled visits and complied with all trial procedures. Exclusion criteria: * Participant was pregnant, or lactating, or of childbearing potential and did not used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. * Participation at the time of study enrollment (or in the 4 weeks \[28 days\] preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 02. * Previous vaccination against influenza (in the previous 6 months) with either the trial vaccine or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * 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). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgement. * Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the trial conduct or completion. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion * Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature greater than or equal to (\>=) 38.0 degree Celsius) on the day of vaccination. A prospective participant should not be 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. * Personal or family history of Guillain Barré syndrome. * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease free for \>= 5 years) The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Healthy volunteers Influenza immunization

Contacts and locations

Locations

  • Investigational Site Number 0560001

    Ghent, BE-9000, Belgium

  • Investigational Site Number 0560002

    Wilrijk, 2610, Belgium

  • Investigational Site Number 2500001

    Gières, 38610, France

  • Investigational Site Number 2500003

    Pierre-Bénite, 69495, France

  • Investigational Site Number 2500004

    Paris, 75014, France

  • Investigational Site Number 2760001

    Essen, 45136, Germany

  • Investigational Site Number 2760002

    Oldenburg in Holstein, 23758, Germany

  • Investigational Site Number 2760003

    Berlin, 10629, Germany

  • Investigational Site Number 2760004

    Berlin, 13347, Germany

  • Investigational Site Number 2760005

    Berlin, 10787, Germany

  • Investigational Site Number 3800001

    Genova, IT-16132, Italy

  • Investigational Site Number 3800003

    Palermo, 90127, Italy

  • Investigational Site Number 5280001

    Utrecht, 3584 CX, Netherlands

  • Investigational Site Number 6160001

    Dębica, 39-200, Poland

  • Investigational Site Number 6160002

    Wola, 43-225, Poland

  • Investigational Site Number 6160003

    Siemianowice Śląskie, 41-103, Poland

  • Investigational Site Number 6160004

    Wroclaw, 50-452, Poland

More trials for these conditions

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