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Vaccine

mRNA-1010 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 6 months (end of study)
Awards & highlights

Study Summary

This study is evaluating whether a vaccine can be safely given to people.

Eligible Conditions
  • Flu

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months (end of study) 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 SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs)
Number of Participants With Solicited Local and Systemic ARs
Number of Participants With Unsolicited AEs
+7 more
Secondary outcome measures
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
+2 more

Side effects data

From 2022 Phase 1 & 2 trial • 885 Patients • NCT04956575
74%
Injection site pain
46%
Fatigue
42%
Headache
32%
Myalgia
26%
Injection site lymphadenopathy
24%
Arthralgia
18%
Chills
10%
COVID-19
8%
Vomiting
6%
Upper respiratory tract infection
6%
Sinusitis
6%
Urinary tract infection
4%
Rhinovirus infection
2%
Road traffic accident
2%
Musculoskeletal chest pain
2%
Gastroenteritis
2%
Muscle strain
2%
Hypertension
2%
Injection site erythema
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 Extension: mRNA-1010 6.25 ug
Phase 2 NH: mRNA-1010 25 ug
Phase 2 Extension: mRNA-1010 25 ug
Phase 2 Extension: mRNA-1010 12.5 ug
Phase 2 NH: mRNA-1010 100 ug
Phase 1/2: mRNA-1010 200 ug
Phase 2 NH: mRNA-1010 50 ug
Phase 1/2: mRNA-1010 50 ug
Phase 1/2: mRNA-1010 100 ug
Phase 2 NH: Afluria Quadrivalent 60 ug
Phase 2 Extension: Afluria Quadrivalent 60 ug
Phase 1/2: Placebo

Trial Design

12Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 NH: mRNA-1010 Dose Level DExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level D by IM injection on Day 1.
Group II: Phase 2 NH: mRNA-1010 Dose Level BExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level B by IM injection on Day 1.
Group III: Phase 2 NH: mRNA-1010 Dose Level AExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level A by IM injection on Day 1.
Group IV: Phase 2 Extension: mRNA-1010 Dose Level FExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level F by IM injection on Day 1.
Group V: Phase 2 Extension: mRNA-1010 Dose Level EExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level E by IM injection on Day 1.
Group VI: Phase 2 Extension: mRNA-1010 Dose Level DExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level D by IM injection on Day 1.
Group VII: Phase 1/2: mRNA-1010 Dose Level CExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level C by IM injection on Day 1.
Group VIII: Phase 1/2: mRNA-1010 Dose Level BExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level B by IM injection on Day 1.
Group IX: Phase 1/2: mRNA-1010 Dose Level AExperimental Treatment1 Intervention
Participants will receive mRNA-1010 at dose level A by intramuscular (IM) injection on Day 1.
Group X: Phase 1/2: PlaceboExperimental Treatment1 Intervention
Participants will receive placebo matching to mRNA-1010 by IM injection on Day 1.
Group XI: Phase 2 NH: Active Comparator Dose Level AActive Control1 Intervention
Participants will receive active comparator at dose level A by IM injection on Day 1.
Group XII: Phase 2 Extension: Active Comparator Dose Level AActive Control1 Intervention
Participants will receive active comparator at dose level A by IM injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1010
2022
Completed Phase 3
~31590
Placebo
1995
Completed Phase 3
~2670

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
108 Previous Clinical Trials
61,378,432 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Nebraska
How old are they?
18 - 65
What site did they apply to?
Meridian Clinical Research, LLC (Lincoln Nebraska)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults
2021. "A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04956575.
~236 spots leftby Apr 2025
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