What side effects are associated with this type of intervention?

The most common side effects of mRNA-based vaccines, such as the mRNA-1010 for influenza, include injection site reactions (pain, redness, swelling), fatigue, headache, muscle pain, chills, fever, and nausea. These side effects are generally mild to moderate and resolve within a few days. Other common treatments for influenza, such as antiviral medications like oseltamivir, can cause side effects including nausea, vomiting, and headache. Inhaled treatments like zanamivir may cause bronchospasm, especially in individuals with respiratory conditions.

What prior FDA approvals exist?

The FDA has approved several treatments for influenza, including antiviral drugs like zanamivir and laninamivir, which are neuraminidase inhibitors. However, specific mRNA-based vaccines for influenza, similar to the mRNA-1010 vaccine currently under study, have not been detailed in the provided context. The mRNA-1010 vaccine represents a novel approach, leveraging mRNA technology to instruct cells to produce proteins that elicit an immune response against influenza.

What other types of research exist?

Promising novel alternatives to the mRNA-1010 vaccine for influenza include: <ol> <li>Multimeric-001 (M-001): This universal influenza vaccine has shown enhanced seroconversion and significant cell-mediated immunity (CMI) in elderly participants.</li> <li>'Alice' strain live influenza virus vaccine: Demonstrated safety and efficacy in healthy adults, with significant antibody responses and reduced infection rates.</li> <li>mRNA vaccines against H10N8 and H7N9: These vaccines have shown robust humoral immune responses and good tolerability in phase 1 clinical trials.</li> </ol>

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Vaccine

mRNA-1010 Vaccine for Flu (IGNITE P303 Trial)

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

Part B: At least 18 and <65 years of age, at the time of signing the ICF.

Part A: At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).

Must not have

Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal and topical steroids are allowed. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.

Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 29

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new flu shot called mRNA-1010 in adults. The vaccine uses mRNA technology to help the body recognize and fight the flu virus. The study aims to see how well the vaccine works and if it is safe.

Who is the study for?

Adults who can follow the study plan, with women of childbearing age needing a negative pregnancy test and contraception. People aged 18+ for Part A, 18-64 for Part B, and 65+ for Part C can join. Those with recent immunosuppressants use, unstable conditions, immune deficiencies, severe allergies to mRNA or flu vaccines including egg protein, recent vaccinations or flu shots are excluded.

What is being tested?

The trial is testing mRNA-1010 seasonal influenza vaccine against a standard licensed flu shot in three parts based on age groups. It aims to assess how well these vaccines work (immunogenicity) and their safety in adults.

What are the potential side effects?

Potential side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, allergic responses especially in those with sensitivities to vaccine components like egg protein.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

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I am 18 years or older and have signed the consent form.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used strong immune system suppressants recently or might need them during the study.

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I have a history of immune system problems or frequent severe infections.

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I have not donated more than 450mL of blood in the last 28 days and do not plan to donate during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Reaching Seroconversion as Measured by HAI Assay

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

0 / 6Eligibility criteria met

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

Common treatments for influenza include vaccines and antiviral medications. Vaccines, such as the mRNA-1010, work by instructing cells to produce a protein that elicits an immune response, thereby preparing the immune system to recognize and combat the actual virus. Antiviral medications, like oseltamivir and zanamivir, inhibit viral replication by targeting specific viral enzymes. These treatments are crucial for flu patients as they help prevent severe illness, reduce the duration of symptoms, and limit the spread of the virus. The mRNA-based vaccines are particularly significant as they can be rapidly developed and updated to match circulating strains, offering a robust and adaptable defense against influenza.

Antibody response to influenza immunization in adult patients with malignant disease.Antibody and cell-mediated immune response to whole virion and split virion influenza vaccine in patients with inflammatory bowel disease on maintenance immunosuppressive and biological therapy.Utility of influenza vaccination for oncology patients.