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Super-Sized flu shot aims to better shield seniors

NCT ID NCT04498832

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a high-dose flu vaccine against a standard-dose one in 2,100 adults aged 60 and older in Japan. The goal was to see if the high-dose version triggers a stronger immune response. Participants received one shot and were followed for 28 days to measure antibody levels and safety.

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 protection against flu for older adults, who are at higher risk of severe illness.
What could go wrong
This trial is complete, but results may not apply to other populations or flu seasons. A stronger immune response doesn't always mean fewer infections.

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

2,100 people

The number who actually took part.

Started

Oct 2020

Finished

Jan 2021

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 : * Aged greater than or equal to (\>=) 60 years on the day of inclusion. * Able to attend all scheduled visits and complied with all study procedures. Exclusion criteria: * Participation at the time of study enrollment (or in the 4 weeks preceding the 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 vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to Visit 02. * Previous vaccination against influenza (in the preceding 6 months) with either the study 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 eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgment. * Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the study conduct or completion. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. * 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) 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 is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for \>=5 years). * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>=37.5 degree Celsius). A prospective participant was not be included in the study until the condition had resolved or the febrile event had subsided. * History of convulsions. * Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine. 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 3920001

    Osaka, Japan

  • Investigational Site Number 3920002

    Suita-Shi, Japan

  • Investigational Site Number 3920003

    Shinjuku-Ku, Japan

  • Investigational Site Number 3920004

    Koganeishi, Japan

  • Investigational Site Number 3920005

    Fukuoka, Japan

  • Investigational Site Number 3920006

    Kumamoto, Japan

  • Investigational Site Number 3920007

    Toshima-Ku, Japan

  • Investigational Site Number 3920008

    Shinjuku-Ku, Japan

  • Investigational Site Number 3920009

    Shinjuku-Ku, Japan

  • Investigational Site Number 3920010

    Yokohama, Japan

More trials for these conditions

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