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Virus Therapy
mRNA-1011.1 + mRNA-1011.2 + mRNA-1012.1 for Flu
Phase 1 & 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) to day 29
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing three new flu vaccines in healthy adults to see how safe they are and how well they help the body fight the flu using mRNA technology.
Eligible Conditions
- Flu
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) to day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) to day 29
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Percentage of Participants With Seroconversion, as Measured by HAI Assay
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Active Control
Group I: mRNA-1012.1 Dose Level BExperimental Treatment1 Intervention
Participants will receive mRNA-1012.1 at dose level B by IM injection on Day 1.
Group II: mRNA-1012.1 Dose Level AExperimental Treatment1 Intervention
Participants will receive mRNA-1012.1 at dose level A by IM injection on Day 1.
Group III: mRNA-1011.2Experimental Treatment1 Intervention
Participants will receive mRNA-1011.2 by IM injection on Day 1.
Group IV: mRNA-1011.1Experimental Treatment1 Intervention
Participants will receive mRNA-1011.1 by intramuscular (IM) injection on Day 1.
Group V: mRNA-1010.3Active Control1 Intervention
Participants will receive mRNA-1010.3 by IM injection on Day 1.
Group VI: mRNA-1010Active Control1 Intervention
Participants will receive mRNA-1010 by IM injection on Day 1.
Group VII: mRNA-1010.2Active Control1 Intervention
Participants will receive mRNA-1010.2 by IM injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1012.1
2023
Completed Phase 2
~700
mRNA-1011.1
2023
Completed Phase 2
~700
mRNA-1011.2
2023
Completed Phase 2
~700
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
118 Previous Clinical Trials
61,584,539 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been in close contact with someone who has had a respiratory syncytial virus or COVID-19 infection in the past 10 days before the study visit.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1011.2
- Group 2: mRNA-1012.1 Dose Level A
- Group 3: mRNA-1012.1 Dose Level B
- Group 4: mRNA-1010.3
- Group 5: mRNA-1010
- Group 6: mRNA-1010.2
- Group 7: mRNA-1011.1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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