What side effects are associated with this type of intervention?

Common side effects of mRNA-based flu vaccines, such as the Quadrivalent Influenza mRNA Vaccine (MRT5407), include local reactions at the injection site (e.g., pain, redness, and swelling), systemic reactions like fever, headache, fatigue, and muscle aches. These side effects are generally mild to moderate and resolve within a few days. Serious adverse events are rare but can include allergic reactions. It is important to discuss any concerns with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several influenza vaccines, including quadrivalent formulations that protect against four different flu virus strains. Traditional flu vaccines, such as the inactivated influenza vaccine (IIV) and the live attenuated influenza vaccine (LAIV), have been widely used. Recently, mRNA-based vaccines, which instruct cells to produce viral proteins to elicit an immune response, have gained attention due to their success in COVID-19 vaccination. The Quadrivalent Influenza mRNA Vaccine (MRT5407) is an example of this innovative approach, aiming to provide broad protection against multiple influenza strains by leveraging mRNA technology.

What other types of research exist?

Promising alternatives to the Quadrivalent Influenza mRNA Vaccine (MRT5407) for flu shot patients in 2024 include the high-dose trivalent vaccine and the recombinant-hemagglutinin (rHA) quadrivalent vaccine. Both have shown strong immunogenicity and safety profiles in clinical trials. Additionally, other mRNA-based influenza vaccines may also be considered as they continue to be developed and tested.

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Vaccine

Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1 for Influenza Immunization

Verified Trial

Phase 1 & 2

Waitlist Available

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years on the day of inclusion

You do not have an immune deficiencies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new mRNA flu vaccine in adults aged 18 and older. The vaccine helps the body learn to fight the flu by mimicking part of the virus. The study will last about a year.

Who is the study for?

This trial is for adults over 18 who haven't had an mRNA vaccine in the last 2 months. Women must be postmenopausal, surgically sterile, or agree to use contraception. People with immune deficiencies can't participate.

What is being tested?

The study tests a new Quadrivalent Influenza mRNA Vaccine MRT5407 against three flu vaccines: standard dose, high-dose (for those ≥65), and recombinant. Participants will receive one intramuscular injection and be monitored.

What are the potential side effects?

Possible side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, muscle aches, headache, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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You are at least 18 years old.

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Your immune system is working properly.

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You have not received an mRNA vaccine in the last two months.

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You cannot have children, either because you have gone through menopause or have had a surgical procedure to prevent pregnancy. If you can have children, you need to use a reliable form of birth control for at least 4 weeks before starting the study and for 12 weeks after the study ends.

Timeline

Screening ~ 3 weeks1 visit

Treatment ~ Varies

Follow Up ~ 12 months7 visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hemagglutination Inhibition Tests

Individual Hemagglutination inhibition (HAI) titer

Antigens, Fungal

+8 more

Secondary study objectives

Individual HAI Ab titer ratio

Antibodies

Individual neutralizing antibodies titer ratio

+3 more

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041

COVID-19 Infection

Upper Respiratory Infection

Cardiovascular Accident (CVA), Unspecified Mechanism

Left partial cranial nerve III palsy

Acute Hyperkalemia

Shortness of Breath

Acute pulmonary embolism and acute deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine

Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 2Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine (dose level 2)

Group II: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine (dose level 1)

Group III: Group 3: RIV4Active Control1 Intervention

participants will receive a single dose of RIV4 vaccine

Group IV: Group 4: QIV-SDActive Control1 Intervention

participants will receive a single dose of QIV-SD vaccine

Group V: Group 5: QIV-HDActive Control1 Intervention

participants will receive a single dose of QIV -HD vaccine (for elderly only)

0 / 4Eligibility 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

Flu shots, including the Quadrivalent Influenza mRNA Vaccine (MRT5407), work by instructing cells to produce viral proteins that trigger an immune response. mRNA vaccines like MRT5407 use messenger RNA to teach cells to make a protein that is part of the influenza virus, prompting the immune system to recognize and fight the virus if encountered in the future. Traditional inactivated vaccines contain killed virus particles, while recombinant vaccines use viral proteins produced through genetic engineering. These methods help the immune system develop memory against the virus, reducing the risk of severe illness. This is crucial for flu shot patients as it enhances their ability to combat influenza, potentially preventing complications and hospitalizations.

Oral Modeling of an Adenovirus-Based Quadrivalent Influenza Vaccine in Ferrets and Mice.Vaccination with recombinant 4 × M2e.HSP70c fusion protein as a universal vaccine candidate enhances both humoral and cell-mediated immune responses and decreases viral shedding against experimental challenge of H9N2 influenza in chickens.A TaqMan reverse transcription polymerase chain reaction (RT-PCR) in vitro potency assay for plasmid-based vaccine products.