A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
NCT ID: NCT05827068
Last Updated: 2025-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
698 participants
INTERVENTIONAL
2023-03-27
2023-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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mRNA-1011.1
Participants will receive mRNA-1011.1 by intramuscular (IM) injection on Day 1.
mRNA-1011.1
Sterile liquid for injection
mRNA-1011.2
Participants will receive mRNA-1011.2 by IM injection on Day 1.
mRNA-1011.2
Sterile liquid for injection
mRNA-1012.1 Dose Level A
Participants will receive mRNA-1012.1 at dose level A by IM injection on Day 1.
mRNA-1012.1
Sterile liquid for injection
mRNA-1012.1 Dose Level B
Participants will receive mRNA-1012.1 at dose level B by IM injection on Day 1.
mRNA-1012.1
Sterile liquid for injection
mRNA-1010
Participants will receive mRNA-1010 by IM injection on Day 1.
mRNA-1010
Sterile liquid for injection
mRNA-1010.2
Participants will receive mRNA-1010.2 by IM injection on Day 1.
mRNA-1010.2
Sterile liquid for injection
mRNA-1010.3
Participants will receive mRNA-1010.3 by IM injection on Day 1.
mRNA-1010.3
Sterile liquid for injection
Interventions
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mRNA-1011.1
Sterile liquid for injection
mRNA-1011.2
Sterile liquid for injection
mRNA-1012.1
Sterile liquid for injection
mRNA-1010
Sterile liquid for injection
mRNA-1010.2
Sterile liquid for injection
mRNA-1010.3
Sterile liquid for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For female participants 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, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.
Exclusion Criteria
* Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to the Randomization Visit (for glucocorticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
* Participant has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection.
* Participant has received a seasonal influenza vaccine or any other influenza vaccine within 180 days prior to the Randomization Visit.
* Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Randomization Visit.
* Participant has had close contact to someone with or been diagnosed themselves with respiratory syncytial virus or SARS-CoV-2 infection as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to the Randomization Visit.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study.
50 Years
75 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Long Beach Research Institute
Lakewood, California, United States
Long Beach Clinical Trials
Long Beach, California, United States
Tekton Research
Fort Collins, Colorado, United States
Critical Care, Pulmonary and Sleep Associates / CCT Research
Lakewood, Colorado, United States
CenExel RCA
Hollywood, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
CenExel FCR
Tampa, Florida, United States
Georgia Clinic / CCT Research
Norcross, Georgia, United States
CenExel CBH
Gaithersburg, Maryland, United States
DelRicht Research
Rockville, Maryland, United States
DelRicht Research
Springfield, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
DelRicht Research
Town and Country, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Healor Primary Care
Las Vegas, Nevada, United States
Meridian Clinical Research, LLC
Vestal, New York, United States
Tekton Research
Edmond, Oklahoma, United States
Tekton Research
Moore, Oklahoma, United States
The Corvallis Clinic, PC
Corvallis, Oregon, United States
Hatboro Medical Associates / CCT Research
Hatboro, Pennsylvania, United States
Trial Management Associates, LLC
Myrtle Beach, South Carolina, United States
Springville Dermatology / CCT Research
Springville, Utah, United States
Countries
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References
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Hsu D, Jayaraman A, Pucci A, Joshi R, Mancini K, Chen HL, Koslovsky K, Mao X, Choi A, Henry C, Vakil J, Stadlbauer D, Jorquera P, Arunkumar GA, Sanchez-Crespo NE, Wadsworth LT, Bhupathy V, Du E, Avanesov A, Ananworanich J, Nachbagauer R. Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/Yamagata strain in US adults aged 50-75 years: a phase 1/2, open-label, randomised trial. Lancet Infect Dis. 2025 Jan;25(1):25-35. doi: 10.1016/S1473-3099(24)00493-6. Epub 2024 Sep 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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mRNA-1011-P101
Identifier Type: -
Identifier Source: org_study_id
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