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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
Summary
This trial is testing a new flu vaccine called mRNA-1010 in people aged 50 and older. The vaccine uses mRNA to help the body build immunity against the flu. The goal is to see if it is safe and effective in preventing the flu in this age group.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days post-vaccination through day 181 or end of influenza season, whichever ends later
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days post-vaccination through day 181 or end of influenza season, whichever ends later
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of Participants Reaching Seroconversion as measured by HAI Assay
Time to First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Influenza A or B
Time to First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Influenza A or B
+3 moreSide effects data
From 2023 Phase 3 trial • 6102 Patients • NCT0541546214%
COVID-19
7%
Upper respiratory tract infection
6%
Influenza like illness
5%
Rhinovirus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluarix Quadrivalent 60 ug
mRNA-1010 50 ug
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
~40020
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for influenza include antiviral medications and vaccines. Antiviral medications, such as oseltamivir, work by inhibiting the neuraminidase enzyme, preventing the virus from spreading within the body.
Vaccines, particularly mRNA-based vaccines like mRNA-1010, function by encoding viral proteins that stimulate the body's immune system to recognize and fight the influenza virus. This is crucial for flu patients as it helps in building immunity, reducing the severity of the disease, and preventing complications.
The mRNA vaccines are particularly significant because they can be rapidly developed and updated to match circulating viral strains, offering a robust and adaptable defense against seasonal influenza.
A candidate H1N1 pandemic influenza vaccine elicits protective immunity in mice.
A candidate H1N1 pandemic influenza vaccine elicits protective immunity in mice.
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Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
113 Previous Clinical Trials
61,439,454 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for the flu in the past 6 months.You don't know if you got a flu shot last year.You had a serious allergic reaction to mRNA or influenza vaccines in the past.You had a flu shot or a different experimental flu shot within the last 180 days.You have been in close contact with someone who has been diagnosed with the flu or who has taken antiviral medicine for the flu in the past 5 days before the screening visit.You have taken strong immune-suppressing drugs for more than 14 days in the past 6 months, or you expect to need these drugs while in the study. Using inhaled, nasal, or topical steroids is okay.You have been in close contact with someone who has had COVID-19 or tested positive for the virus in the last 10 days.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1010
- Group 2: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Flu Patient Testimony for trial: Trial Name: NCT05566639 — Phase 3
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