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Study of mRNA-1010 Seasonal Influenza Vaccine in Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older

NCT05827978•ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures.
•For assigned females at birth and of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.
•Part A:
•At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
•Part B:
•At least 18 and \<65 years of age, at the time of signing the ICF.
•Part C:
•At least 65 years of age or older, at the time of signing the ICF.

Exclusion Criteria

•Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
•Participant is acutely ill or febrile (temperature ≥38.0℃elcius \[100.4°Fahrenheit\]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window.
•Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
•Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
•Participant has tested positive for influenza by local health authority-approved testing methods within 150 days (for Part A) or 180 days (for Parts B and C) prior to Day 1.
•Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.
•Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal and topical steroids are allowed. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.
•Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.
•Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) (for part A) or within 6 months (180 days) (for Parts B and C) prior to Day 1.
•Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.
+2 more criteria

Locations (103)

Pinnacle Research Group

Anniston, Alabama, United States

North Alabama Research Center LLC

Athens, Alabama, United States

Cullman Research Center

Cullman, Alabama, United States

Medical Affiliated Research Center Inc

Huntsville, Alabama, United States

Desert Clinical Research - CCT

Mesa, Arizona, United States

Foothills Research Center - CCT

Phoenix, Arizona, United States

Fiel Family & Sports Medicine - PC - CCT

Tempe, Arizona, United States

Noble Clinical Research

Tucson, Arizona, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Velocity Clinical Research, Banning

Banning, California, United States

Key Dates

Start Date

April 17, 2023

Primary Completion Date

June 24, 2024

Completion Date

June 24, 2024

Last Updated

July 10, 2025

Enrollment

8,411

ACTUAL participants

Conditions

Seasonal Influenza

Interventions

mRNA-1010

BIOLOGICAL

Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

BIOLOGICAL

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

NCT06602024

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: July 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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Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

Inclusion Criteria

Exclusion Criteria

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

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