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New flu vaccine shows promise in south korean trial

NCT ID NCT05144945

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tested a new recombinant flu vaccine (RIV4) against a standard inactivated flu vaccine (IIV4) in 301 healthy adults aged 18 and older in South Korea. The study measured antibody levels and safety over 29 days. The goal was to see if the new vaccine triggers a stronger immune response with similar safety.

What this could mean

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

Active substance
Quadrivalent Recombinant Influenza Vaccine (RIV4)
What this could lead to
If successful, this could offer a more effective or equally protective flu vaccine option for adults, especially those 50 and older.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all populations or flu seasons. The new vaccine may not prove superior to the existing one.

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

301 people

The number who actually took part.

Started

Dec 2021

Finished

Sep 2022

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

18 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 \>=18 years on the day of inclusion. * Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination. * Able to attend all scheduled visits and complied with all study procedures. * Informed consent form was signed and dated. * A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: Was 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 Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study intervention administration until at least 4 weeks after study intervention administration. A female participant of childbearing potential must had a negative highly sensitive pregnancy test (urine) before the first dose of study intervention. Exclusion Criteria: Participants were excluded from the study if any of the following criteria applied: * Participation at the time of study enrollment, or in the 6 months preceding the study vaccination, or planned participation during the present study period in another clinical study investigating involving an Investigational Medical Product (IMP) (vaccine, drug), medical device, or medical procedure or in any other type of medical research. * Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2. * 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 abnormal immune function: immunosuppression, suspected congenital or acquired immunodeficiency based on medical history and physical examination, 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 study or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on the Investigator's judgment. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction 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 trial conduct or completion (Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection). * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>=38.0°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * 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). * 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) of the Investigator or employee with direct involvement in the proposed study. The above information was not intended to contain all considerations relevant to a 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 :4100001

    Seoul, Seoul-teukbyeolsi, 152-703, South Korea

  • Investigational Site Number :4100002

    Seoul, 07441, South Korea

  • Investigational Site Number :4100003

    Ansan-si, Gyeonggi-do, 15355, South Korea

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