mRNA Vaccine for COVID-19 and Flu
Recruiting at 15 trial locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: ModernaTX, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.
Eligibility Criteria
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.Inclusion Criteria
I am not able to become pregnant.
I understand and can follow the study's requirements.
I can sign the consent form and follow the study's requirements.
See 2 more
Exclusion Criteria
I haven't taken immune-weakening drugs in the last 6 months.
I have been vaccinated against COVID-19 within the last 90 days.
I have a condition that increases my risk for severe flu complications.
See 6 more
Treatment Details
Interventions
- mRNA-1083 (Virus Therapy)
Trial OverviewThe 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.
Participant Groups
6Treatment groups
Experimental Treatment
Group I: Part 2 Group 6: mRNA-1083 Lot EExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot E as a single injection on Day 1 in Part 2.
Group II: Part 2 Group 5: mRNA-1083 Lot AExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 2.
Group III: Part 1 Group 4: mRNA-1083 Lot DExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot D as a single injection on Day 1 in Part 1.
Group IV: Part 1 Group 3: mRNA-1083 Lot CExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot C as a single injection on Day 1 in Part 1.
Group V: Part 1 Group 2: mRNA-1083 Lot BExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot B as a single injection on Day 1 in Part 1.
Group VI: Part 1 Group 1: mRNA-1083 Lot AExperimental Treatment1 Intervention
Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ModernaTX, Inc.
Lead Sponsor
Trials
127
Recruited
66,790,000+
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris