A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
NCT ID: NCT05333289
Last Updated: 2024-02-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
572 participants
INTERVENTIONAL
2022-04-06
2022-11-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
NCT05868382
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
NCT05827068
Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
NCT05827978
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
NCT05375838
A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults
NCT04956575
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
mRNA-1030 Dose Level A
Participants will receive mRNA-1030 at Dose Level A by intramuscular (IM) injection on Day 1.
mRNA-1030
Sterile liquid for injection
mRNA-1020 Dose Level A
Participants will receive mRNA-1020 at Dose Level A by IM injection on Day 1.
mRNA-1020
Sterile liquid for injection
mRNA-1030 Dose Level B
Participants will receive mRNA-1030 at Dose Level B by IM injection on Day 1.
mRNA-1030
Sterile liquid for injection
mRNA-1020 Dose Level B
Participants will receive mRNA-1020 at Dose Level B by IM injection on Day 1.
mRNA-1020
Sterile liquid for injection
mRNA-1030 Dose Level C
Participants will receive mRNA-1030 at Dose Level C by IM injection on Day 1.
mRNA-1030
Sterile liquid for injection
mRNA-1020 Dose Level C
Participants will receive mRNA-1020 at Dose Level C by IM injection on Day 1.
mRNA-1020
Sterile liquid for injection
mRNA-1010
Participants will receive mRNA-1010 by IM injection on Day 1.
mRNA-1010
Sterile liquid for injection
Active Comparator
Participants will receive an active comparator by IM injection on Day 1.
Active Comparator
Sterile liquid for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mRNA-1030
Sterile liquid for injection
mRNA-1020
Sterile liquid for injection
mRNA-1010
Sterile liquid for injection
Active Comparator
Sterile liquid for injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 90 days following vaccine administration, and not currently breastfeeding.
Exclusion Criteria
* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* 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 or immune-modifying drugs for \>14 days in total within 180 days prior to screening (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* 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 Northern Hemisphere (NH) 2021-2022 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to Day 1.
* Participant tested positive for influenza by CDC-recommended testing methods within 180 days prior to Day 1.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ModernaTX, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Foothills Research Center
Phoenix, Arizona, United States
Alliance for MultiSpecialty Research
Coral Gables, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
IACT Health
Columbus, Georgia, United States
Meridian Clinical Research
Sioux City, Iowa, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Meridian Clinical Research
Endwell, New York, United States
Lucas Research
Morehead City, North Carolina, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Meridian Clinical Research
Cincinnati, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
LinQ Research, LLC
Pearland, Texas, United States
Olympus Family Medicine
Salt Lake City, Utah, United States
South Ogden Family Medicine
South Ogden, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
mRNA-1020-P101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.