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A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age

NCT06602024•ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
•Participants who are assigned female at birth or can become pregnant are eligible to participate if:
•* The participant is a person of nonchildbearing potential (PONCBP) or
•* The participant is a person of childbearing potential (POCBP) who:
•Is not breast/chest feeding.
•Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline).
•Has a negative highly sensitive pregnancy test (urine or serum as required by local regulation or institutional review board \[IRB\]/independent ethics committee \[IEC\]) at the Screening Visit and before study intervention (if the Day 1 \[Baseline\] Visit is not on the same day as the Screening Visit).

Exclusion Criteria

•Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4° Fahrenheit \[F\]\]) within 72 hours prior to Day 1 (Baseline).
•Close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®/oseltamivir) within 5 days prior to Day 1 (Baseline).
•History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
•Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
•Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline).
•History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
•Malignancy within 2 years prior to Day 1 (Baseline) (adequately treated basal cell carcinoma and squamous cell carcinoma are allowed).
•Received corticosteroids at ≥10 milligram (mg)/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
•Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
•Treated with antiviral therapies for influenza (for example, Tamiflu) within 180 days prior to Day 1 (Baseline).
+4 more criteria

Locations (301)

Pinnacle Research Group, Llc

Anniston, Alabama, United States

North Alabama Research Center, LLC

Athens, Alabama, United States

Flourish Research

Birmingham, Alabama, United States

EmVenio Research Brimingham, AL

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Optimal Research

Huntsville, Alabama, United States

Velocity Clinical Research

Mobile, Alabama, United States

Lenzmeier Family Medicine

Glendale, Arizona, United States

DM Clinical Research

Phoenix, Arizona, United States

Helios Clinical Research

Phoenix, Arizona, United States

Key Dates

Start Date

September 16, 2024

Primary Completion Date

August 21, 2025

Completion Date

August 21, 2025

Last Updated

September 10, 2025

Enrollment

40,817

ACTUAL participants

Conditions

Seasonal Influenza

Interventions

mRNA-1010

BIOLOGICAL

Fluarix®

BIOLOGICAL

Influsplit® Tetra

BIOLOGICAL

Fluarix Tetra

BIOLOGICAL

Alpharix® Tetra

BIOLOGICAL

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

NCT05827978

Seasonal Influenza

View study

COMPLETEDPHASE1/PHASE2

A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

NCT05827068

Seasonal Influenza

View study

COMPLETEDPHASE1/PHASE2

A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

NCT05333289

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

Inclusion Criteria

Exclusion Criteria

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010

Yearly Strain Variation Study, 2009/2010