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One-Stop shot? study combines flu and COVID boosters for seniors

NCT ID NCT04969276

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study looked at whether it's safe and effective to give a high-dose flu vaccine and a Moderna COVID-19 booster at the same time to adults 65 and older. 306 volunteers who had already received two Moderna shots took part. Researchers measured side effects and antibody levels to see if getting both vaccines together worked as well as getting them separately.

What this could mean

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

Active substance
Fluzone High-Dose Quadrivalent influenza vaccine and Moderna COVID-19 vaccine (mRNA-1273)
What this could lead to
If successful, this could show that getting a flu shot and a COVID-19 booster at the same time is safe and effective for older adults, simplifying vaccination schedules.
What could go wrong
This is a phase 2 study with only 306 participants, so results may not apply to everyone. The study is completed, but it primarily measured immune response and short-term side effects, not long-term protection.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

306 people

The number who actually took part.

Started

Jul 2021

Finished

Feb 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

65 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 \>= 65 years of age on the day of inclusion. * In good health or with underlying medical condition(s) that were judged to be stable by the Investigator. A stable medical condition was defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. * Participants who previously received 2 injections of Moderna COVID-19 Vaccine with the second dose received at least 5 months before Visit 1. * Abled to attend all scheduled visits and to complied 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 3 months preceding planned inclusion). * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances. * Previous dermal filler injection (either lips or face fillers). * Thrombocytopenia, contraindicated IM injection. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicated IM vaccination. * 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 study intervention administration or febrile illness (temperature \>= 100.4°Fahrenheit \[F\] \[38.0° Celsius {C}\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * History of serious adverse reaction to any influenza or COVID-19 vaccines. * Personal history of Guillain-Barré syndrome (GBS). * 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. * Any condition that in the opinion of the Investigator posed a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine. * Receipt of any vaccine in the 4 weeks preceding the study intervention(s) administration or planned receipt of any vaccine in the period between Visit 01 and 4 weeks following the study intervention(s) administration. Note: Vaccination of Group 3 participants with Fluzone High-Dose Quadrivalent vaccine at the end of the study was not considered by the Sponsor as meeting this exclusion criterion. * Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months. * 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 vaccine, drug, medical device, or medical procedure. * Deprived of freedom by an administrative or court order, or 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 (i.e., parent, spouse, natural or adopted child) 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 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

    Peoria, Illinois, 61614, United States

  • Investigational Site Number :8400002

    Austin, Texas, 78705, United States

  • Investigational Site Number :8400003

    Glendale, Arizona, 85306, United States

  • Investigational Site Number :8400004

    Vista, California, 92083, United States

  • Investigational Site Number :8400005

    Centennial, Colorado, 80112, United States

  • Investigational Site Number :8400006

    San Diego, California, 92108, United States

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