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mRNA Vaccines for Flu and COVID-19

No longer recruiting at 17 trial locations
MC
Overseen ByModerna Clinical Trials Support Center
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: ModernaTX, Inc.
Must not be taking: Immunosuppressants, Steroids
Disqualifiers: Acute illness, Drug abuse, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new mRNA vaccines for flu and COVID-19 to assess their safety and effectiveness. Different groups will receive various versions of the vaccines to identify the best candidate for future studies. Healthy individuals, fully vaccinated against COVID-19 and without a recent flu shot, might be suitable participants. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants, you may not be eligible to participate. 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?

Previous studies have shown mRNA-1083 to be safe. Research indicates it generated strong immune responses against the flu and COVID-19. Recipients reported side effects similar to those of other vaccines, such as mild pain at the injection site or fatigue. Serious side effects have been rare.

This clinical trial is in its early stages, focusing on the vaccine's safety and tolerability. At this stage, treatments are generally considered safe, but more information is needed to confirm this for mRNA-1083. Prospective participants should consult a healthcare provider about any concerns before joining a trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these mRNA vaccines for flu and COVID-19 because they offer a new way of fighting these viruses by using the same mRNA technology that was groundbreaking in COVID-19 vaccines like Pfizer's and Moderna's. Unlike traditional vaccines, which often use inactivated viruses, these mRNA vaccines work by instructing cells to produce proteins that trigger an immune response, potentially enhancing effectiveness and safety. Additionally, mRNA vaccines can be rapidly updated to target new virus strains, offering a flexible and timely response to evolving pathogens. This adaptability could make mRNA vaccines a powerful tool in managing seasonal flu and potential COVID-19 variants.

What evidence suggests that this trial's treatments could be effective for flu and COVID-19?

Research shows that the mRNA-1083 vaccine, which participants in this trial may receive, creates strong defenses against both COVID-19 and flu viruses. It has produced better immune responses than other flu vaccines in older adults, suggesting high effectiveness. Similarly, the mRNA-1010 vaccine, another option in this trial, has demonstrated strong defenses against seasonal flu strains. It performed well in studies, showing better results than some traditional flu vaccines. For COVID-19, the next-generation mRNA-1273.222 and mRNA-1283.222 vaccines, also part of this trial, have improved immune responses, offering better protection against the virus compared to earlier versions. Overall, these mRNA vaccines show promising potential in fighting both flu and COVID-19.678910

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 65–79 who've completed their initial COVID-19 vaccine series at least 4 months ago and haven't had a flu shot in the last 5 months. Participants must be willing to attend up to 5 visits and take about 4 calls over roughly 7 months.

Inclusion Criteria

Would you be able and willing to participate in to up to 5 in-person visits and about 4 phone calls over a time period of up to 7 months?
Are you 65–79 years of age?
In general, do you consider yourself to be in good health?
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of either mRNA-based vaccines or comparator vaccines on Day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, reactogenicity, and immunogenicity, with primary outcome measures assessed at Day 29

4 weeks
1 visit (in-person), additional monitoring as needed

Extended Follow-up

Participants are monitored for long-term immunogenicity and safety, with secondary outcome measures assessed at Day 181

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Fluarix
  • Fluzone HD
  • mRNA-1010
  • mRNA-1010.4
  • mRNA-1083.1
  • mRNA-1083.2
  • mRNA-1083.3
  • mRNA-1273.222
  • mRNA-1283.222

Trial Overview

The study tests several mRNA-based vaccines against influenza and COVID-19, including new formulations like mRNA-1283.222, to find the best composition and dose for future larger trials.

How Is the Trial Designed?

37

Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: mRNA-1083 Composition 2 Dose DExperimental Treatment1 Intervention
Group II: Part 2: mRNA-1083 Composition 2 Dose CExperimental Treatment1 Intervention
Group III: Part 2: mRNA-1083 Composition 2 Dose BExperimental Treatment1 Intervention
Group IV: Part 2: mRNA-1083 Composition 2 Dose AExperimental Treatment1 Intervention
Group V: Part 2: mRNA-1083 Composition 1 Dose DExperimental Treatment1 Intervention
Group VI: Part 2: mRNA-1083 Composition 1 Dose CExperimental Treatment1 Intervention
Group VII: Part 2: mRNA-1083 Composition 1 Dose BExperimental Treatment1 Intervention
Group VIII: Part 2: mRNA-1083 Composition 1 Dose AExperimental Treatment1 Intervention
Group IX: Part 1 Cohort B7: mRNA-1083.3Experimental Treatment1 Intervention
Group X: Part 1 Cohort B6: mRNA-1083.2 Dose CExperimental Treatment1 Intervention
Group XI: Part 1 Cohort B5: mRNA-1083.2 Dose BExperimental Treatment1 Intervention
Group XII: Part 1 Cohort B4: mRNA-1083.2 Dose AExperimental Treatment1 Intervention
Group XIII: Part 1 Cohort B3: mRNA-1083.1 Dose CExperimental Treatment1 Intervention
Group XIV: Part 1 Cohort B2: mRNA-1083.1 Dose BExperimental Treatment1 Intervention
Group XV: Part 1 Cohort B1: mRNA-1083.1 Dose AExperimental Treatment1 Intervention
Group XVI: Part 1 Cohort A7: mRNA-1083.3Experimental Treatment1 Intervention
Group XVII: Part 1 Cohort A6: mRNA-1083.2 Dose CExperimental Treatment1 Intervention
Group XVIII: Part 1 Cohort A5: mRNA-1083.2 Dose BExperimental Treatment1 Intervention
Group XIX: Part 1 Cohort A4: mRNA-1083.2 Dose AExperimental Treatment1 Intervention
Group XX: Part 1 Cohort A3: mRNA-1083.1 Dose CExperimental Treatment1 Intervention
Group XXI: Part 1 Cohort A2: mRNA-1083.1 Dose BExperimental Treatment1 Intervention
Group XXII: Part 2: Influenza Vaccine 1Active Control1 Intervention
Group XXIII: Part 1 Cohort A12: Influenza Vaccine 1Active Control1 Intervention
Group XXIV: Part 1 Cohort A13: Influenza Vaccine 2Active Control1 Intervention
Group XXV: Part 1 Cohort B8: Investigational Influenza Vaccine 1Active Control1 Intervention
Group XXVI: Part 1 Cohort A10: COVID-19 Vaccine 1Active Control1 Intervention
Group XXVII: Part 2: Investigational COVID-19 Vaccine 2Active Control1 Intervention
Group XXVIII: Part 1 Cohort A9: Investigational COVID-19 Vaccine 1Active Control1 Intervention
Group XXIX: Part 1 Cohort A11: Investigational Influenza Vaccine 2Active Control1 Intervention
Group XXX: Part 1 Cohort B9: Investigational COVID-19 Vaccine 1Active Control1 Intervention
Group XXXI: Part 1 Cohort B10: COVID-19 Vaccine 1Active Control1 Intervention
Group XXXII: Part 1 Cohort B11: Investigational Influenza Vaccine 2Active Control1 Intervention
Group XXXIII: Part 2: COVID-19 Vaccine 2Active Control1 Intervention
Group XXXIV: Part 1 Cohort A8: Investigational Influenza Vaccine 1Active Control1 Intervention
Group XXXV: Part 2: Investigational Influenza Vaccine 1 Dose BActive Control1 Intervention
Group XXXVI: Part 2: Investigational Influenza Vaccine 1 Dose AActive Control1 Intervention
Group XXXVII: Part 1 Cohort B12: Influenza Vaccine 1Active Control1 Intervention

Find a Clinic Near You

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 profile image

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 mRNA-1273 Moderna COVID-19 vaccine was found to have a safety profile in a real-world setting in Japan that is consistent with clinical trial data, indicating it is well-tolerated among participants.
In a survey of 301 respondents, 98% reported local and systemic adverse events following the second dose, with younger individuals (18-29 years) and females experiencing higher rates of adverse events after the first dose, although these differences diminished with subsequent doses.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University.Okumura, K., Hara, A., Inada, I., et al.[2022]
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 phase 1 clinical trial involving 104 healthy adults, the mRNA-1283 vaccine was found to be safe, with no serious adverse events reported, indicating a favorable safety profile.
All doses of the mRNA-1283 vaccine (10, 30, and 100 µg) produced strong immune responses comparable to the established mRNA-1273 vaccine, suggesting its potential effectiveness in generating immunity against SARS-CoV-2.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults.Yassini, P., Hutchens, M., Paila, YD., 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.

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.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05415462

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 ...

5.

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.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40332892/

Immunogenicity and Safety of Influenza and COVID-19 ...

In this study, mRNA-1083 met noninferiority criteria and induced higher immune responses than recommended standard care influenza (standard and high dose) and ...

7.

nature.com

nature.com/articles/s41541-025-01145-6

Comparing Moderna's mRNA-1083 and Pfizer's dual-target ...

Moderna has reported promising trial results for mRNA-1083, showing strong immune responses against both SARS-CoV-2 and influenza antigens with ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06097273

NCT06097273 | A Study of mRNA-1083 (SARS-CoV-2 and ...

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered ...

9.

infectiousdiseaseadvisor.com

infectiousdiseaseadvisor.com/news/multicomponent-vaccine-for-covid19-and-influenza-prevention/

Multicomponent Vaccine for COVID-19, Influenza Shows ...

They aimed to determine the immunogenicity and safety of mRNA-1083 against seasonal influenza and COVID-19 in adults aged 50 years and older.

10.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2838635

Influenza and COVID-19 Multicomponent Vaccine in Adults ...

Accordingly, the inclusion of all 4 recommended strains (A/H1N1, A/H3N2, B/Victoria, and B/Yamagata) in the investigational mRNA-1083 vaccine ...

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