One-Stop shot? study combines flu and COVID boosters for seniors
NCT ID NCT04969276
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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306 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Feb 2022
- Lead sponsor
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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
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Investigational Site Number :8400001
Peoria, Illinois, 61614, United States
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Investigational Site Number :8400002
Austin, Texas, 78705, United States
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Investigational Site Number :8400003
Glendale, Arizona, 85306, United States
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Investigational Site Number :8400004
Vista, California, 92083, United States
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Investigational Site Number :8400005
Centennial, Colorado, 80112, United States
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Investigational Site Number :8400006
San Diego, California, 92108, United States
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