What side effects are associated with this type of intervention?

The most common treatments for the flu include antiviral medications like oseltamivir and baloxavir, as well as various types of vaccines. For mRNA-based vaccines, such as the mRNA-1010 being studied, side effects are generally mild and can include pain at the injection site, fatigue, headache, muscle pain, chills, fever, and nausea. These side effects are typically short-lived and resolve on their own. Serious side effects are rare but can include severe allergic reactions.

What prior FDA approvals exist?

Currently, there are no FDA-approved mRNA-based vaccines specifically for the treatment of influenza. Traditional flu vaccines, such as inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIV), have been widely used. These vaccines typically contain inactivated virus or live but weakened virus to stimulate an immune response. The mRNA-1010 vaccine, which is being studied, represents a novel approach by using mRNA technology to encode viral proteins, aiming to enhance the immune response against influenza.

What other types of research exist?

Promising novel alternatives to mRNA-1010 for flu patients in 2024 include T cell-based influenza vaccines and the Multimeric-001 universal influenza vaccine. T cell-based vaccines focus on inducing cellular immunity, which can provide broad protection against various influenza strains. The Multimeric-001 vaccine has shown enhanced seroconversion and significant cellular immune responses to multiple strains, making it a strong candidate for improving immune response in the elderly population.

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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

No Placebo-Only Group

Pivotal Trial

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

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

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 more

Side effects data

From 2023 Phase 3 trial • 6102 Patients • NCT05415462

14%

COVID-19

Upper respiratory tract infection

Influenza like illness

Rhinovirus infection

100%

80%

60%

40%

20%

Study treatment Arm

Fluarix Quadrivalent 60 ug

mRNA-1010 50 ug

Awards & Highlights

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.

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

Do I qualify?Apply below to find out

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.