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Vaccine

mRNA-1010 Vaccine for Flu

Phase 3
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 14 days post-vaccination through day 181 or end of influenza season, whichever ends later
Awards & highlights

Study Summary

This trial will test if a new vaccine can prevent seasonal influenza in adults aged 50 and over.

Who is the study for?
Adults aged 50 and older who can follow the study's procedures are eligible for this flu vaccine trial. Women of childbearing age must have a negative pregnancy test, use contraception, or abstain from sex to prevent pregnancy during the study. People with recent flu infections, blood donations, immunodeficiencies, severe allergies to vaccines or their components, recent exposure to influenza or COVID-19, or those on certain immunosuppressants cannot participate.Check my eligibility
What is being tested?
The trial is testing mRNA-1010 Seasonal Influenza Vaccine against an approved quadrivalent inactivated seasonal influenza vaccine in adults over 50. The goal is to see if mRNA-1010 is safe and effective at preventing the flu compared to the standard vaccine.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with vaccines such as soreness at injection site, fatigue, headache, muscle pain, feverish feelings which are usually mild and resolve within a few days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days post-vaccination through day 181 or end of influenza season, whichever ends later
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days post-vaccination through day 181 or end of influenza season, whichever ends later 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 Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
+1 more
Secondary outcome measures
Change from Baseline in Geometric Mean Fold Rise (GMFR) at Day 29 as Measured by HAI Assay
Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay
Number of Participants Reaching Seroconversion as measured by HAI Assay
+7 more

Side effects data

From 2022 Phase 1 & 2 trial • 885 Patients • NCT04956575
64%
Injection site pain
40%
Fatigue
36%
Headache
32%
Myalgia
28%
Injection site lymphadenopathy
26%
Arthralgia
12%
Vomiting
10%
Chills
8%
Injection site induration
6%
COVID-19
6%
Injection site erythema
6%
Hypertension
6%
Rhinorrhoea
4%
Pyrexia
4%
Upper respiratory tract infection
4%
Nasal congestion
4%
Rash
2%
Anxiety
2%
Muscle strain
2%
Influenza
2%
Cough
2%
Arthropod bite
2%
Urinary tract infection
2%
Rhinovirus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 Extension: mRNA-1010 12.5 ug
Phase 2 NH: mRNA-1010 100 ug
Phase 2 NH: mRNA-1010 25 ug
Phase 2 Extension: mRNA-1010 25 ug
Phase 2 NH: Afluria Quadrivalent 60 ug
Phase 2 Extension: mRNA-1010 6.25 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 Extension: Afluria Quadrivalent 60 ug
Phase 1/2: Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: mRNA-1010Experimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Group II: Licensed Quadrivalent Inactivated Seasonal Influenza VaccineActive Control1 Intervention
Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine 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
~31660

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
105 Previous Clinical Trials
61,345,054 Total Patients Enrolled

Media Library

mRNA-1010 Seasonal Influenza Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05566639 — Phase 3
Flu Research Study Groups: mRNA-1010, Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Flu Clinical Trial 2023: mRNA-1010 Seasonal Influenza Vaccine Highlights & Side Effects. Trial Name: NCT05566639 — Phase 3
mRNA-1010 Seasonal Influenza Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05566639 — Phase 3
Flu Patient Testimony for trial: Trial Name: NCT05566639 — Phase 3

Frequently Asked Questions

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

Are we presently enrolling people in this study?

"Yes, this information is available on the government-run website clinicaltrials.gov. The study was created on 9/14/2022 and updated as recently as 9/30/2022."

Answered by AI

Is this research being conducted at more than one facility in the city?

"One hundred different medical centres are running this study. If you wish to enroll, try and choose a location near you from the list of one hundred clinics, which can be found in Riverside, Omaha, Suffolk and other cities."

Answered by AI

How many people are part of this clinical study?

"To complete this trial, 23000 individuals who meet the pre-determined requirements must participate. Trial sites include Benchmark Research-Texas in Riverside, California and Papillon Research Centre in Omaha, Nebraska."

Answered by AI

When will mRNA-1010 be available for public consumption?

"There is ample evidence to support the safety of mRNA-1010, as this medication has progressed to a Phase 3 trial."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Alabama
Texas
Other
How old are they?
18 - 65
What site did they apply to?
North Alabama Research Center, LLC
ARS - Meridien Research
South Florida Research Center, Inc.
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0

Why did patients apply to this trial?

Afraid of contracting Flu during winter. I thought it'd be fun to play a part in research.
PatientReceived 1 prior treatment
I’m trying this study because I want to learn more. I have had a fever for as long as I can remember and most of the over-the-counter medicines don't have much. I would love to find something that actually worked.
PatientReceived 1 prior treatment
Power sent me a few trials that would be ideal, and this was one of the close(r) ones which was Akron - it's about 90 miles away and wouldn't be far to drive when needing an injection.
PatientReceived 2+ prior treatments
~9004 spots leftby Mar 2025