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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
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 belowSelect...
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:Select...
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
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 • 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
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.
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.
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
113 Previous Clinical Trials
61,453,542 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unsure if I've had the flu vaccine recently.I understand and can follow the study's requirements.I am between 18 and 64 years old.I have used strong immune system suppressants recently or might need them during the study.I am 18 years or older and have signed the consent form.I am 65 years old or older.I haven't had any vaccines within 28 days before or plan to within 28 days after starting the study treatment.You have tested positive for the flu within the specified time frame before the start of the study.I am not pregnant, using birth control, or have not been sexually active for 28 days.I have a history of immune system problems or frequent severe infections.You have had a serious allergic reaction to mRNA vaccines or any components of the vaccines.I've been in close contact with someone who has the flu or is being treated for it within the last 5 days.I have not donated more than 450mL of blood in the last 28 days and do not plan to donate during the study.I have received a flu shot within the last 5 or 6 months, depending on the trial part.
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: NCT05827978 — Phase 3
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