Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
NCT ID: NCT05868382
Last Updated: 2024-12-20
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
PHASE2
270 participants
INTERVENTIONAL
2023-05-15
2023-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
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-1010 Dose C
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
mRNA-1010
Sterile liquid for injection
mRNA-1010.4 Dose B
Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.
mRNA-1010.4
Sterile liquid for injection
mRNA-1010.4 Dose C
Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.
mRNA-1010.4
Sterile liquid for injection
mRNA-1010.6 Dose A
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
mRNA-1010.6
Sterile liquid for injection
mRNA-1010.6 Dose B
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
mRNA-1010.6
Sterile liquid for injection
mRNA-1010.6 Dose C
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
mRNA-1010.6
Sterile liquid for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mRNA-1010
Sterile liquid for injection
mRNA-1010.4
Sterile liquid for injection
mRNA-1010.6
Sterile liquid for injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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 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) prior to Day 1.
* Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.
* Participant is not aware whether they have received an influenza vaccine in the prior 12 months.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.
18 Years
49 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.
CenExel RCA
Hollywood, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Rockville Internal Medicine
Rockville, Maryland, United States
DM Clinical Research
Southfield, Michigan, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Meridian Clinical Research
Lincoln, Nebraska, United States
United Medical Associates
Binghamton, New York, United States
DM Clinical Research
Sugar Land, Texas, United States
Texas Center for Drug Development
Tomball, Texas, 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-CRID-004
Identifier Type: -
Identifier Source: org_study_id