← Back to Search

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 up to day 7 (7 days after vaccination)
Awards & highlights

Study Summary

This trial studies the safety and effectiveness of 3 new flu vaccines compared to an existing one.

Eligible Conditions
  • Flu

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 7 (7 days after vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 7 (7 days after vaccination) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants With Unsolicited Adverse Events (AEs)
Secondary outcome measures
Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
Change From Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Percentage of Participants With Seroconversion, as Measured by HAI Assay

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,425 Total Patients Enrolled

Media Library

mRNA-1011.1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05827068 — Phase 1 & 2
Flu Research Study Groups: mRNA-1011.2, mRNA-1012.1 Dose Level A, mRNA-1012.1 Dose Level B, mRNA-1010.3, mRNA-1010, mRNA-1010.2, mRNA-1011.1
Flu Clinical Trial 2023: mRNA-1011.1 Highlights & Side Effects. Trial Name: NCT05827068 — Phase 1 & 2
mRNA-1011.1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05827068 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experimental research accept participants who are 45 years or older?

"The target population for this research includes individuals between the ages of 50 and 75."

Answered by AI

Can I be enrolled in this trial?

"To qualify for this study, applicants must be aged between 50 and 75 years old and have an active case of influenza. Up to 700 people are eligible to enroll in the trial."

Answered by AI

Are there any vacancies remaining for those wishing to participate in this trial?

"As shown on clinicaltrials.gov, this medical research study is still seeking participants; it was first posted on the 27th of March in 2023 and has been revised most recently as of April 12th that same year."

Answered by AI

In how many distinct areas is this research experiment being managed?

"At the present moment, 22 different medical centres are accepting patient enrolment for this trial. Locations range from Long Beach to Fort Collins and Hollywood as well as numerous other cities. Individuals should consider selecting a nearby location in order to minimize travel needs if they choose to participate."

Answered by AI

How many individuals have been recruited for the clinical trial thus far?

"Indeed, clinicaltrials.gov confirms that the trial is actively recruiting participants. First posted on March 27th 2023 and last updated on April 12th 2023, this study seeks to include 700 individuals from 22 different medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
What site did they apply to?
Healor Primary Care
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
2023. "A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05827068.
All > Montreal
~350 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top