mRNA-1010 Vaccine for Flu

No longer recruiting at 1 trial location

Overseen By Moderna WeCare Team

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Immunoglobulins

Disqualifiers: Immunodeficiency, Severe infections, Anaphylaxis, others

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

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new flu vaccine, mRNA-1010, to evaluate its safety and effectiveness. The trial compares this vaccine to other flu vaccines by examining immune responses and any side effects. It targets healthy adults who have had the flu or receive flu shots regularly. Participants may include those with frequent flu infections or those interested in advancing flu prevention methods. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants or certain immune therapies, you may need to stop them before joining the trial. It's best to discuss your specific medications with the trial team.

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

Research has shown that the mRNA-1010 vaccine is generally safe. In one study, some participants experienced side effects, but these were usually mild and less common in adults. The vaccine also triggered a strong immune response lasting several months.

For those receiving the combination of mRNA-1010 and mRNA-1345, it's important to note that the mRNA-1345 component has already received FDA approval for another condition, indicating it has passed strict safety tests for that use.

Regarding mRNA-1045, early studies are examining its safety and the body's response. Results are still forthcoming, but the goal is to confirm the vaccine's safety.

Overall, researchers are thoroughly testing these mRNA vaccines to ensure they are safe and effective against the flu. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional flu vaccines, which often use inactivated or egg-based influenza viruses to trigger an immune response, the mRNA-1010 vaccine is unique because it uses messenger RNA (mRNA) technology. This innovative approach involves using mRNA to instruct cells in the body to produce proteins that mimic the flu virus, thereby stimulating an immune response without the need for the actual virus. Researchers are excited about mRNA-1010 because it can potentially be updated more rapidly to match circulating flu strains, offering a quicker and more adaptable response to annual flu outbreaks. Additionally, mRNA-1010 could lead to a more robust and long-lasting immune response compared to traditional vaccines.

What evidence suggests that this trial's treatments could be effective for flu?

Research has shown that the mRNA-1010 vaccine, one of the treatments tested in this trial for the flu, has promising results. In earlier studies, this vaccine was 26.6% more effective than regular flu vaccines at preventing infections from influenza A and B strains. It also triggered strong immune responses in adults, suggesting it might offer better protection. In this trial, some participants will receive a combination of mRNA-1010 and mRNA-1345, targeting both the flu and RSV (a virus that causes respiratory infections), to test its effectiveness. Another vaccine under study in this trial is mRNA-1045, noted for potentially providing protection against both the flu and RSV, which could enhance its overall effectiveness. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can become pregnant but are not currently, using contraception or abstaining from pregnancy-causing activities. They must have a BMI of 18-<40 kg/m^2 (Part A only), no acute illness/fever before vaccination, and no history of severe allergies to mRNA or flu vaccines.

Inclusion Criteria

I am not pregnant, not breastfeeding, and will use birth control during and after the vaccine trial.

In Part A of the study, your BMI needs to be between 18 and less than 40. There is no BMI requirement for Part B.

Exclusion Criteria

You had a serious allergic reaction in the past after getting an mRNA or flu vaccine, or any of the ingredients in those vaccines, like egg protein.

I have used strong immune system suppressants for more than 2 weeks in the last 6 months.

Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of the assigned vaccine by intramuscular injection on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with seroresponse measured at Day 29

4 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for long-term immunogenicity with seroresponse measured at Days 57, 121, and 181

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adjuvanted Quadrivalent Influenza Vaccine
• Egg-based Quadrivalent Influenza Vaccine
• Inactivated Influenza Vaccine
• mRNA-1010

Trial Overview The study tests the safety and immune response effectiveness of mRNA-1010 compared to other flu vaccines. Participants will be assessed on Day 29 for their body's defense against specific influenza strains.

How Is the Trial Designed?

Group I: Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years) Experimental Treatment 1 Intervention

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

Group II: Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years) Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Group III: Part C - Arm 3: mRNA-1045 (Age Group 18-50 years) Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1045 by IM injection on Day 1.

Group IV: Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years) Experimental Treatment 2 Interventions

Participants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29.

Group V: Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years) Experimental Treatment 2 Interventions

Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.

Group VI: Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years) Active Control 1 Intervention

Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.

Group VII: Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years) Active Control 1 Intervention

Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.

Group VIII: Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years) Active Control 1 Intervention

Participants will receive a single dose of inactivated influenza vaccine by IM injection 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

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]

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]

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]

The mRNA vaccines for H10N8 and H7N9 influenza viruses were found to be safe and well-tolerated, with no serious adverse events reported in the trials involving 201 participants for H10N8 and 156 participants for H7N9.

Both vaccines elicited strong humoral immune responses, with the 100-µg dose of H10N8 achieving 100% of participants with protective antibody levels, and the 50-µg dose of H7N9 achieving 100% seroconversion in neutralization tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Feldman, RA., Fuhr, R., Smolenov, I., et al.[2020]

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]

During the 2009-2010 influenza A/H1N1v vaccination campaign in Denmark, 607 reports of adverse events were submitted, primarily involving non-serious reactions occurring within one day of vaccination, indicating a relatively low risk of serious side effects.

The study found no strong signals for unknown or serious adverse events linked to the vaccine, highlighting the safety of the influenza A/H1N1v vaccination during this period, although it also pointed out the limitations of relying solely on spontaneous reporting for assessing vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November 2009-March 2010. Folkenberg, M., Callréus, T., Svanström, H., et al.[2011]

Both paper-based and web-based surveys reported similar rates of local and systemic adverse events following influenza vaccination, indicating that the method of data collection does not significantly affect the safety outcomes reported.

The paper-based survey, which recruited participants through general practitioners, was more representative of the elderly population targeted for influenza vaccination, suggesting that combining recruitment methods could enhance the accuracy of safety monitoring during mass vaccination campaigns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of different collection methods for reported adverse events following pandemic and seasonal influenza vaccination. Kemmeren, J., Honsbeek, M., Dijkstra, F., et al.[2017]

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]

Citations

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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 ...

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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 ...

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A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults The primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against ...

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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.

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Safety and Immunogenicity of mRNA-1010, an Investigational ... A single dose of mRNA-1010 quadrivalent seasonal influenza vaccine elicited broad and durable humoral responses that persisted through 6 months.

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Immunogenicity and safety of mRNA-based seasonal ... A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults. Vaccine 50, 126847 (2025). Article ...

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mRNA-1010, an mRNA-Based Influenza Vaccine, Is Safe ... Safety Data. Safety Set – April 30, 2025 data cutoff. Solicited adverse reaction subset : ~6000 participants. Based on median of 6 months of ...