What side effects are associated with this type of intervention?

Common side effects of flu shots, including those using mRNA technology like the Quadrivalent Influenza mRNA Vaccine MRT5410, typically include local reactions at the injection site such as pain, redness, and swelling. Systemic reactions may include fever, headache, muscle aches, and fatigue. These side effects are generally mild 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 strains of the virus. Notably, mRNA technology has been successfully used in COVID-19 vaccines, and similar approaches are being explored for influenza. The Quadrivalent Influenza mRNA Vaccine MRT5410 is an example of this innovative approach, aiming to induce an immune response against four influenza strains. While traditional flu vaccines like the inactivated and recombinant types have been widely used, the mRNA-based flu vaccine represents a new frontier in influenza prevention.

What other types of research exist?

Promising alternatives to the Quadrivalent Influenza mRNA Vaccine MRT5410 for flu shot patients in 2024 include: 1) Recombinant Influenza Vaccines (e.g., RIV4), which use recombinant DNA technology to produce the hemagglutinin protein of the virus. 2) Adenovirus-Based Quadrivalent Influenza Vaccines, which have shown favorable immune responses in animal models. 3) VSV (Vesicular Stomatitis Virus) Vector Vaccines, which have been effective in preclinical studies. These alternatives leverage different mechanisms to induce immunity and may offer comparable or enhanced protection against influenza.

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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

You are at least 18 years old

Answer yes if you have *not* received a Flu Vaccine within the last six (6) months

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 helps the body recognize and fight the flu by teaching it to make a harmless piece of the virus. The goal is to see if this new vaccine is safe and effective.

Who is the study for?

This trial is for adults 18 years and older who haven't had a flu shot in the last six months. Participants must be able to attend up to eight study visits over one year.

What is being tested?

The trial tests a new Quadrivalent Influenza mRNA Vaccine MRT5410 against three other flu vaccines: high dose, standard dose, and recombinant versions. It involves one injection and compares safety and immune response.

What are the potential side effects?

Potential side effects may include pain at the injection site, fatigue, headache, muscle pain, feverish feelings or chills which are common with flu vaccines.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

Have you not received a flu vaccine in the last six months? If yes, then you meet this criterion.

Select...

You are available to come to the study site for up to 8 visits within a year.

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 MRT5410 high doseExperimental Treatment1 Intervention

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

Group II: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium doseExperimental Treatment1 Intervention

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

Group III: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low doseExperimental Treatment1 Intervention

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

Group IV: Group 6: QIV-HDActive Control1 Intervention

participants will receive a single dose of QIV -HD vaccine

Group V: Group 4: RIV4Active Control1 Intervention

participants will receive a single dose of RIV4 vaccine

Group VI: Group 5: QIV-SDActive Control1 Intervention

participants will receive a single dose of QIV-SD vaccine

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

The Quadrivalent Influenza mRNA Vaccine MRT5410 uses mRNA technology to induce an immune response against four strains of influenza. The mRNA in the vaccine instructs cells to produce proteins that resemble parts of the influenza virus, which then stimulate the immune system to recognize and combat the virus. This targeted approach is significant for flu shot patients as it enhances the immune response and provides broader protection against multiple strains of influenza, potentially reducing the incidence and severity of flu infections.

Effect of vibration associated with cryotherapy on vaccine-related pain and anxiety levels in adults: study protocol for a randomized clinical trial.A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above (INVICTUS): a study protocol.A cluster randomized controlled trial comparing relative effectiveness of two licensed influenza vaccines in US nursing homes: Design and rationale.