mRNA Vaccine for Flu

No longer recruiting at 329 trial locations

Overseen By Moderna WeCare Team

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ModernaTX, Inc.

Must not be taking: Corticosteroids, Immunosuppressants, Antivirals, others

Disqualifiers: Immunodeficiency, Malignancy, Anaphylaxis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new mRNA-based flu vaccine called mRNA-1010. Researchers aim to compare its effectiveness to existing flu vaccines in preventing flu-like symptoms caused by influenza A or B. Participants will receive either the new vaccine or a standard flu vaccine for comparison. This study suits individuals who have not received a seasonal flu vaccine or flu treatment like Tamiflu in the past six months and are not currently sick or experiencing flu-like symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking flu vaccine.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you have used corticosteroids at ≥10 mg/day of prednisone for more than 14 days within 90 days before the trial, or if you have used systemic immunosuppressive treatments within 180 days before the trial. You also cannot have received any vaccines within 28 days before the trial or plan to receive them within 14 days after the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the mRNA-1010 flu vaccine is generally well-tolerated. Earlier studies found no serious side effects or deaths linked to the vaccine. The vaccine also prompted strong immune responses in adults, preparing the body to fight the flu virus effectively.

The trial is in an advanced stage, indicating that earlier studies have already checked its safety. For those considering joining the trial, available evidence suggests the vaccine is safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional flu vaccines, which are typically made using inactivated viruses, the mRNA-1010 vaccine uses messenger RNA technology. This innovative approach tells the body how to make proteins that trigger an immune response, potentially leading to a more robust and quicker immunity against the flu. Researchers are excited because mRNA vaccines can be developed more rapidly and adjusted more easily to match circulating flu strains than conventional vaccines. This could mean better protection and more flexibility in responding to seasonal flu changes.

What evidence suggests that mRNA-1010 might be an effective treatment for flu?

Research has shown that the mRNA-1010 vaccine, which participants in this trial may receive, holds promise in preventing the flu. Studies have found it offers 26.6% better protection than other flu vaccines, making it more effective at preventing illnesses caused by flu viruses. The vaccine uses mRNA technology to enhance the immune system, particularly against certain flu strains. These findings suggest that mRNA-1010 could be a strong option for flu prevention. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 50 years or older. It's designed to test the safety and effectiveness of a new flu vaccine called mRNA-1010 compared to licensed flu vaccines like Fluarix® and Influsplit®.

Inclusion Criteria

Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline)

I am female or can become pregnant and am eligible to participate.

I cannot become pregnant.

Exclusion Criteria

Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline)

History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures

I have taken high-dose steroids recently or might need them during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either mRNA-1010 or an active comparator on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to approximately 26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1010

Trial Overview The study compares the new mRNA-1010 vaccine with established influenza vaccines. Participants will receive one type of vaccine and be monitored for their body's reaction and protection against flu-like symptoms caused by influenza A or B.

How Is the Trial Designed?

Group I: mRNA-1010 Experimental Treatment 1 Intervention

Participants will receive a single injection of mRNA-1010 on Day 1.

Group II: Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra Active Control 4 Interventions

Participants will receive a single injection of active comparator trivalent influenza vaccine (TIV) or quadrivalent influenza vaccine (QIV) (Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra) on Day 1.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

Cardiac complications, particularly myopericarditis, were the most frequently reported severe adverse events associated with mRNA COVID-19 vaccines, with systemic reactions being more common after the second dose.

Despite the higher number of reported adverse effects following the Pfizer vaccine, the review concluded that the overall benefits of mRNA vaccines in controlling the COVID-19 pandemic significantly outweigh the risks of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events Related to COVID-19 mRNA Vaccines; a Systematic Review. SeyedAlinaghi, S., Karimi, A., Pashaei, Z., et al.[2022]

The mRNA-lipid nanoparticle vaccine has been shown to provide protection against 20 different lineages of the influenza virus, indicating its broad efficacy.

This innovative vaccine approach utilizes lipid nanoparticles to deliver mRNA, which instructs cells to produce viral proteins, prompting an immune response that can recognize and combat multiple influenza strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influenza universe in an mRNA vaccine. Kelvin, AA., Falzarano, D.[2023]

A novel mRNA vaccine targeting conserved proteins of the H1N1 influenza virus successfully induced broadly reactive T cells in both naïve and influenza-experienced ferrets, suggesting its potential effectiveness in diverse populations.

The booster vaccination significantly enhanced protection against a different strain of influenza (H7N9), indicating that this mRNA vaccine strategy could provide robust immunity against evolving influenza viruses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A universal influenza mRNA vaccine candidate boosts T cell responses and reduces zoonotic influenza virus disease in ferrets. van de Ven, K., Lanfermeijer, J., van Dijken, H., et al.[2023]

Two doses of an mRNA vaccine targeting influenza H10 in rhesus macaques led to strong immune responses, including protective antibody levels and specific T cell activation, indicating its potential efficacy against influenza.

The vaccine induced a rapid immune response characterized by the infiltration of immune cells at the injection site and lymph nodes, which is crucial for generating effective long-term immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficient Targeting and Activation of Antigen-Presenting Cells In Vivo after Modified mRNA Vaccine Administration in Rhesus Macaques. Liang, F., Lindgren, G., Lin, A., et al.[2018]

mRNA vaccines for influenza have been shown to induce strong and long-lasting immunity in both very young and very old mice, demonstrating their potential effectiveness across age groups.

These vaccines not only provide protection against influenza A virus but also target multiple viral antigens, suggesting they could serve as cross-protective vaccines, similar in efficacy to licensed vaccines in larger animals like pigs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective efficacy of in vitro synthesized, specific mRNA vaccines against influenza A virus infection. Petsch, B., Schnee, M., Vogel, AB., et al.[2021]

A comparative safety study involving 18,755 individuals vaccinated with mRNA COVID-19 vaccines and 27,895 individuals vaccinated with influenza vaccines found that mRNA vaccines had a different safety profile, with more systemic reactions like chills and fatigue compared to the influenza vaccine.

While mRNA COVID-19 vaccines showed a higher risk for some manageable cardiovascular issues, such as hypertensive crisis and supraventricular tachycardia, they had a lower risk of serious neurological complications compared to influenza vaccines, indicating a generally favorable safety profile for mRNA vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. Kim, MS., Jung, SY., Ahn, JG., et al.[2022]

Annual influenza vaccination is the largest vaccination effort in the USA, with ongoing discussions about moving towards universal vaccination strategies.

While there is substantial safety data, rare serious adverse events, such as Guillain-Barré syndrome linked to the 1976-1977 vaccine and oculorespiratory syndrome in Canada, highlight the need for continuous monitoring of vaccine safety, especially during pandemic situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience. Iskander, J., Broder, K.[2008]

The quadrivalent mRNA-1010 vaccine demonstrated strong humoral immunogenicity, eliciting higher hemagglutination inhibition (HAI) titers against influenza A strains compared to a standard inactivated vaccine, indicating its potential effectiveness in preventing influenza.

No significant safety concerns were reported during the trial, although mild adverse reactions were more common with mRNA-1010, suggesting it is generally safe for use in healthy adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis. Lee, IT., Nachbagauer, R., Ensz, D., et al.[2023]

In a study of 98 elderly individuals in Brazil, 84.7% of reported post-vaccination events were classified as non-severe, with local reactions being the most common (64.3%).

The findings highlight the importance of providing targeted information to healthcare providers to ensure safe vaccination practices and minimize avoidable adverse events in the elderly population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events following immunization against influenza the in elderly in Brazil]. Rodrigues, D., de Marchi Bacellos de Dalri, RC.[2023]

In a retrospective study of 66 individuals who received the H1N1 vaccine during a 2010 mass vaccination campaign in São Paulo, the most common adverse events reported were mild symptoms such as fever, headache, myalgia, and injection site pain.

Importantly, no serious adverse events were reported, indicating that the H1N1 vaccine was generally safe for those vaccinated at this center.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous reporting of adverse events following pandemic influenza A (H1N1) immunization in a reference center in the State of São Paulo, Brazil. Oliveira, DS., Lara, AN., Luiz, AM., et al.[2022]

A quadrivalent mRNA vaccine targeting four seasonal influenza virus strains was shown to induce strong antibody responses in mice, with effective protection against illness even at low doses (as low as 1 μg per antigen).

The mRNA vaccine demonstrated the ability to prevent weight loss and protect against morbidity and mortality from influenza, highlighting its potential as a promising alternative to traditional influenza vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seasonal quadrivalent mRNA vaccine prevents and mitigates influenza infection. Kackos, CM., DeBeauchamp, J., Davitt, CJH., et al.[2023]

Citations

1. cidrap.umn.edu cidrap.umn.edu/influenza-vaccines/moderna-announces-promising-efficacy-results-mrna-flu-vaccine-trial

Moderna announces promising efficacy results ... - CIDRAP In a press release, the company said its candidate flu vaccine, called mRNA 1010, showed superior results, with an rVE of 26.6% in the overall ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11970786/

An mRNA-based seasonal influenza vaccine in adults The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains ...

3. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-1010-P302

A Clinical Trial of a Seasonal Influenza (Flu) Vaccine ... The Glow Trial is assessing the safety and efficacy of an investigational vaccine, called mRNA-1010, aimed at preventing seasonal influenza in adults over 50.

4. healio.com healio.com/news/infectious-disease/20250702/moderna-reports-positive-phase-3-data-for-mrna-seasonal-flu-vaccine

Moderna reports positive phase 3 data for mRNA seasonal ... According to results reported by Moderna, the relative vaccine efficacy (rVE) of mRNA-1010 was 26.6% (95% CI, 16.7%-35.4%) higher than the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25001446

A phase 3 randomized safety and immunogenicity trial of ... mRNA-1010 is an mRNA-based vaccine targeting seasonal influenza A and B strains. mRNA-1010 elicited strong immune responses in adults of all ages.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11793046/

Safety and Immunogenicity of mRNA-1010, an Investigational ... No vaccine-related serious adverse events or deaths were reported. In parts 1 and 2, a single dose of mRNA-1010 (25–200 µg) elicited robust day 29 ...

7. nature.com nature.com/articles/s41467-025-60938-4

Immunogenicity and safety of mRNA-based seasonal ... Through 6 months, no deaths or serious adverse events were related to vaccination with mRNA-1020 or mRNA-1030 at any dose. These findings ...

8. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(24)00493-6/abstract

Safety and immunogenicity of mRNA-based seasonal ... We aimed to evaluate the safety and immunogenicity of three next-generation seasonal influenza mRNA vaccines with different compositions that encode for ...