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Virus Therapy
mRNA Vaccine for COVID-19 and Flu
Phase 2
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who could become pregnant: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy
Be between 18 and 65 years old
Must not have
Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (e.g., infliximab), within 180 days prior to Day 1 or plans to do so during the study
Received a licensed/authorized SARS-CoV-2 vaccine within 90 days prior to Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety, side effects, and immune response of the mRNA-1083 vaccine when given as a single shot in adults between 50 and 65 years old.
Who is the study for?
This clinical trial is for adults aged between 50 and 65 who are in good health. The study aims to test a new vaccine targeting COVID-19 and the flu.
What is being tested?
The trial is testing mRNA-1083, a combined vaccine for SARS-CoV-2 (the virus that causes COVID-19) and influenza. Participants will receive one intramuscular injection of the vaccine.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, general feelings of being unwell such as fever or fatigue, muscle pain, headache, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and am using or willing to use effective birth control or abstain from activities that could lead to pregnancy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken immune-weakening drugs in the last 6 months.
Select...
I have been vaccinated against COVID-19 within the last 90 days.
Select...
I have a history of immune system problems or frequent severe infections.
Select...
I have taken high-dose steroids recently or might need them during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Group 4: mRNA-1083 Lot DExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot D as a single injection on Day 1.
Group II: Group 3: mRNA-1083 Lot CExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot C as a single injection on Day 1.
Group III: Group 2: mRNA-1083 Lot BExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot B as a single injection on Day 1.
Group IV: Group 1: mRNA-1083 Lot AExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot A as a single injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1083
2023
Completed Phase 3
~8080
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
121 Previous Clinical Trials
66,784,455 Total Patients Enrolled
41 Trials studying COVID-19
66,580,371 Patients Enrolled for COVID-19