Flu Vaccine for Adults

Recruiting at 26 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi Pasteur, a Sanofi Company

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

Disqualifiers: Immunodeficiency, Myocarditis, GBS, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

910 Participants Needed

Trial Summary

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 immunosuppressive therapy or long-term systemic corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment Quadrivalent Influenza mRNA Vaccine MRT5421, MRT5424, and MRT5429?

Research on similar mRNA-based influenza vaccines shows promising results. A quadrivalent mRNA vaccine was found to induce strong immune responses and protect against influenza in animal studies, and another mRNA vaccine (mRNA-1010) showed higher immune responses compared to standard vaccines in human trials. ^{1 2 3 4 5}

Is the quadrivalent mRNA flu vaccine safe for adults?

The quadrivalent mRNA flu vaccine, evaluated in a clinical trial, showed no safety concerns in healthy adults. Some mild reactions were more frequent with the vaccine compared to a standard flu shot, but overall, it was considered safe. ^{5 6 7 8 9}

How is the Quadrivalent Influenza mRNA Vaccine different from other flu vaccines?

The Quadrivalent Influenza mRNA Vaccine is unique because it uses mRNA technology, which instructs cells to produce a protein that triggers an immune response, unlike traditional vaccines that use inactivated or recombinant virus components. This approach can potentially offer a more robust immune response and faster production times compared to conventional flu vaccines. ^{3 5 8 9 10}

What is the purpose of this trial?

This trial is testing new mRNA flu vaccines in adults aged 18 and older. The vaccines work by using genetic instructions to help the body recognize and fight the flu virus. The study aims to see if these new vaccines are safe and effective. The first mRNA vaccines against potentially pandemic avian H10N8 and H7N9 influenza viruses were evaluated for safety and effectiveness over a period of several years.

Eligibility Criteria

Adults aged 18 and older can join this study to test new flu vaccines. People with a history of severe allergic reactions to any vaccine ingredients or who are immunocompromised may not be eligible.

Inclusion Criteria

I am a woman who can have children and have a recent negative pregnancy test.

I am not pregnant or breastfeeding and either cannot have children or will use birth control.

Exclusion Criteria

I have had heart inflammation, nerve issues, or brain swelling in the past.

I have not taken immunosuppressives or long-term steroids in the last 6 months.

Known systemic hypersensitivity to study intervention components; history of life-threatening reaction to study interventions; allergic reaction after administration of mRNA vaccine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of one of the Quadrivalent Influenza mRNA Vaccines or a control

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including adverse events and antibody titers

12 months

Treatment Details

Interventions

• Quadrivalent Influenza mRNA Vaccine MRT5421
• Quadrivalent Influenza mRNA Vaccine MRT5424
• Quadrivalent Influenza mRNA Vaccine MRT5429

Trial Overview The trial is testing the safety and immune response of three different mRNA flu vaccines against standard dose, high-dose, and recombinant flu vaccines given as a single shot in the muscle.

Participant Groups

Group I: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4 Experimental Treatment 1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group II: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3 Experimental Treatment 1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group III: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2 Experimental Treatment 1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group IV: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1 Experimental Treatment 1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group V: Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 2 Experimental Treatment 1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5424

Group VI: Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1 Experimental Treatment 1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5424

Group VII: Quadrivalent Influenza mRNA Vaccine MRT5421 Dose 1 Experimental Treatment 1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5421

Group VIII: Quadrivalent Influenza HD Vaccine Active Control 1 Intervention

participants will receive a single dose of QIV -HD vaccine (for adults ≥ 65 years of age only)

Group IX: Quadrivalent Influenza SD Vaccine Active Control 1 Intervention

participants will receive a single dose of QIV-SD vaccine

Group X: Quadrivalent Influenza RIV4 Vaccine Active Control 1 Intervention

participants will receive a single dose of RIV4 vaccine

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Findings from Research

The high-dose inactivated influenza vaccine quadrivalent (HD-IIV4) has been shown to be safe and effective in preventing influenza in adults aged 65 and older, with improved immunogenicity against additional B strains compared to standard vaccines.

Despite some increased adverse reactions like injection-site pain and myalgia, HD-IIV4 is recommended as the vaccine of choice for older adults due to its superior efficacy compared to other influenza vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults. Chahine, EB.[2021]

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]

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]

The quadrivalent influenza vaccine AdimFlu-S showed strong immunogenicity in a study of 174 healthy children aged 3 to 17, achieving high seroprotection rates above 96.4% for all vaccine strains.

The vaccine was well tolerated with no serious adverse events reported over a 6-month follow-up period, indicating it is a safe option for improving protection against different influenza B lineages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. Chang, CY., Cho, CY., Lai, CC., et al.[2021]

The quadrivalent influenza vaccine (QIV) demonstrated similar efficacy to the trivalent influenza vaccine (TIV) for the three common strains, but showed superior immunogenicity for the additional B lineages not included in TIV, with significant increases in seroprotection and seroconversion rates.

Both QIV and TIV had comparable safety profiles, with no serious adverse events reported; however, QIV was associated with a slightly higher incidence of injection-site pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. Moa, AM., Chughtai, AA., Muscatello, DJ., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Seasonal quadrivalent mRNA vaccine prevents and mitigates influenza infection. [2023]

5. England 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a novel quadrivalent subunit influenza vaccine in animal models. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. [2018]