What side effects are associated with this type of intervention?

Common side effects of flu shots, including mRNA-based vaccines like the Quadrivalent Influenza mRNA Vaccine MRT5413, typically include mild to moderate reactions such as pain at the injection site, fatigue, headache, muscle pain, chills, fever, and joint pain. These side effects are generally short-lived, resolving within a few days. Severe allergic reactions are rare but can occur. 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 include inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIV). Recently, mRNA technology has been explored for flu vaccines, similar to the Quadrivalent Influenza mRNA Vaccine MRT5413, which instructs cells to produce proteins that elicit an immune response. While mRNA vaccines have been successfully used for COVID-19, their application for influenza is still under investigation, and no mRNA-based flu vaccines have been approved by the FDA as of now.

What other types of research exist?

Promising novel alternatives to the Quadrivalent Influenza mRNA Vaccine MRT5413 for flu shot patients in 2024 include: 1) Quadrivalent recombinant influenza vaccines (RIV4), which use recombinant DNA technology to produce the hemagglutinin protein of the virus. 2) High-dose quadrivalent inactivated vaccines (QIV-HD), particularly for older adults, which contain a higher amount of antigen to elicit a stronger immune response. 3) Newer mRNA-based influenza vaccines that may offer broader protection and quicker production times. 4) Adenovirus-based quadrivalent influenza vaccines, which have shown favorable immune responses in animal models and could provide a novel delivery mechanism.

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mRNA Vaccine

mRNA Flu Vaccine for Flu

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

Answer yes if you have *not* had a flu vaccine within the last 6 months

Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 91, day 181 and day 366

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new mRNA flu vaccine in adults aged 18 and older. The vaccine uses mRNA to help the body recognize and fight four different strains of the flu. The study will last about a year.

Who is the study for?

This trial is for adults over 18 in the US or over 21 in Puerto Rico who haven't had a flu shot in the last 6 months. Women must be postmenopausal, surgically sterile, or willing to use contraception. Participants should not be pregnant and must agree to follow study procedures.

What is being tested?

The trial tests a new Quadrivalent Influenza mRNA Vaccine MRT5413 given as one injection. It's compared with three other flu vaccines: standard-dose, high-dose (for those ≥65), and recombinant influenza vaccine. The goal is to check safety and immune response.

What are the potential side effects?

Possible side effects may include pain at the injection site, fatigue, headache, muscle pain, joint pain, fever, chills and nausea. These are common reactions similar to other flu vaccines but can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

Select...

Have you had a flu vaccine in the last 6 months? If your answer is yes, you will be excluded from the study.

Select...

I am at least 18 years old (21 if in Puerto Rico) on the day I join the study.

Select...

I cannot become pregnant or agree to use birth control during and after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 91, day 181 and day 366

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 91, day 181 and day 366

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 91, day 181 and day 366 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Individual HAI titer ratio

Individual Hemagglutination inhibition (HAI) titer

Number of participants archiving HAI seroconversion against Antigens

+8 more

Secondary study objectives

Individual HAI Ab titer ratio

Individual antibodies HAI titer ratio

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

6Treatment groups

Experimental Treatment

Active Control

Group I: Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high doseExperimental Treatment1 Intervention

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

Group II: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium doseExperimental Treatment1 Intervention

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

Group III: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low doseExperimental Treatment1 Intervention

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

Group IV: Group 4: RIV4Active Control1 Intervention

participants will receive a single dose of RIV4 vaccine

Group V: Group 5: QIV-SDActive Control1 Intervention

participants will receive a single dose of QIV-SD vaccine

Group VI: Group 6: QIV-HDActive Control1 Intervention

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

0 / 3Eligibility 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

mRNA-based flu vaccines, such as the Quadrivalent Influenza mRNA Vaccine MRT5413, work by instructing cells to produce specific proteins that trigger an immune response against the influenza virus. This immune response helps the body recognize and combat the virus if exposed later. This method is important for flu shot patients as it offers a targeted and efficient way to build immunity without using live virus, thereby enhancing vaccine safety and reducing the risk of adverse reactions.

How far have we reached in development of effective influenza vaccine?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.