High-Dose Vaccine for Flu

Recruiting at 21 trial locations

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

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Guillain-Barré, Bleeding disorder, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1178 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, long-term systemic corticosteroids, or anticoagulants, you may not be eligible to participate.

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, long-term corticosteroids, or anticoagulants, you may not be eligible to participate.

What data supports the idea that High-Dose Vaccine for Flu is an effective treatment?

The available research shows that the High-Dose Vaccine for Flu, specifically designed for people aged 65 and older, produces a stronger immune response compared to standard-dose vaccines. This is because it contains four times more of a key component that helps the body fight the flu. Studies have shown that this vaccine provides better protection against the flu and reduces the risk of flu-related hospitalizations in older adults. Additionally, it has been found to be a cost-effective option compared to standard-dose vaccines. ^{1 2 3 4 5}

What data supports the effectiveness of the high-dose trivalent influenza vaccine (Fluzone High-Dose) treatment?

Research shows that Fluzone High-Dose, which contains four times more of a key ingredient than standard flu vaccines, produces a stronger immune response in people aged 65 and older, offering better protection against the flu and related hospitalizations. ^{1 2 3 4 5}

What safety data exists for the high-dose flu vaccine?

The high-dose flu vaccine, known as Fluzone High-Dose, was approved by the FDA in 2009 for people aged 65 and older. Prelicensure clinical trials reviewed by the Advisory Committee on Immunization Practices (ACIP) showed a favorable safety profile. A randomized, controlled trial demonstrated enhanced immunologic response while maintaining safety. Further studies are ongoing to confirm effectiveness. The vaccine is available as both trivalent and quadrivalent formulations, with safety data supporting its use in older adults. ^{1 2 3 5 6}

Is the high-dose flu vaccine safe for humans?

The high-dose flu vaccine, known as Fluzone High-Dose, has been shown to have a favorable safety profile in people aged 65 and older, according to clinical trials. It was approved by the FDA and is considered safe for use in this age group. ^{1 2 3 5 6}

Is the High-Dose trivalent influenza vaccine a promising drug for flu prevention?

Yes, the High-Dose trivalent influenza vaccine, also known as Fluzone High-Dose, is promising for flu prevention in people aged 65 and older. It has been shown to produce a stronger immune response and offer better protection against the flu compared to standard-dose vaccines. This makes it a valuable option for older adults who are at higher risk of severe flu complications. ^{1 2 3 4 6}

How is the Fluzone High-Dose vaccine different from other flu vaccines?

Fluzone High-Dose is unique because it contains four times the amount of hemagglutinin (a protein that helps the body recognize and fight the flu virus) compared to standard flu vaccines, making it more effective for people aged 65 and older who typically have weaker immune responses. ^{1 2 3 4 6}

What is the purpose of this trial?

The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age.

Eligibility Criteria

This trial is for adults aged 50 to 64 who are in good health and can commit to the study schedule. Women must either be postmenopausal, surgically sterile, or willing to use effective contraception. Participants need a negative pregnancy test if applicable and must provide informed consent.

Inclusion Criteria

I am between 50 and 64 years old.

I agree to use effective birth control or abstain from sex during the study period.

I am not able to have children because I am postmenopausal or have been surgically sterilized.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of either IIV-HD or IIV-SD on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including measurement of antibody titers and adverse events

180 days

Treatment Details

Interventions

• High-Dose trivalent influenza vaccine

Trial Overview The study compares two flu vaccines: a high-dose version versus a standard-dose one. It aims to assess how well these vaccines work (immunogenicity) and their safety in adults aged 50 through 64.

Participant Groups

Group I: IIV-HD Experimental Treatment 1 Intervention

Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1

Group II: IIV-SD Active Control 1 Intervention

Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1

High-Dose trivalent influenza vaccine is already approved in United States, European Union for the following indications:

Approved in United States as Fluzone High-Dose for:

• Influenza prevention in adults 65 years and older
• Influenza prevention in adults 18 through 64 years who have had a solid organ transplant and are taking immunosuppressive medications

Approved in European Union as Fluzone High-Dose Trivalent for:

• Influenza prevention in adults 65 years and older

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

Fluzone® High Dose, approved by the FDA for individuals 65 and older, contains four times more hemagglutinin than standard vaccines, leading to a stronger immune response against influenza.

A recent randomized controlled trial showed that this high-dose vaccine maintains a favorable safety profile while enhancing immunologic response, supporting its use in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the vaccination of the elderly against influenza: role of a high-dose vaccine. Sullivan, SJ., Jacobson, R., Poland, GA.[2010]

Fluzone High-Dose is an injectable influenza vaccine specifically designed for individuals aged 65 and older, containing a higher amount of hemagglutinin antigen to improve immune response compared to standard vaccines.

The FDA approved Fluzone High-Dose for this age group due to their increased risk of severe influenza outcomes, although the Advisory Committee on Immunization Practices did not express a preference for it over other vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010. [2017]

In a study involving 2670 healthy adults aged 65 and older, the quadrivalent high-dose influenza vaccine (IIV4-HD) demonstrated non-inferior immunogenicity compared to the licensed trivalent high-dose vaccine (IIV3-HD) for all four influenza strains.

IIV4-HD showed superior immune responses for both B strains compared to IIV3-HD that did not contain the same B-lineage strain, while maintaining a similar safety profile, indicating it is a more effective option without added safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial. Chang, LJ., Meng, Y., Janosczyk, H., et al.[2020]

Fluzone® High-Dose (IIV3-HD) vaccine, designed for adults aged 65 and older, has been shown to produce significantly stronger antibody responses and better protection against influenza compared to standard-dose vaccines, based on multiple studies since 2004.

IIV3-HD is considered a cost-effective option for older adults, potentially even saving costs compared to standard-dose vaccines, and further research is suggested to explore its benefits for individuals with weakened immune systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluzone® High-Dose Influenza Vaccine. Robertson, CA., DiazGranados, CA., Decker, MD., et al.[2018]

High dose trivalent influenza vaccine (TIV) significantly reduces the incidence of laboratory-confirmed influenza, particularly the A(H3N2) strain, in older adults, with a relative risk of 0.76 based on a meta-analysis of 16 trials involving 47,857 patients.

The high dose TIV was associated with a stronger immune response and fewer serious adverse events compared to the standard dose, indicating it is a safer and more effective option for preventing influenza in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of high dose trivalent influenza vaccine in adults and immunosuppressed populations - A systematic review and meta-analysis. Leibovici Weissman, Y., Cooper, L., Sternbach, N., et al.[2021]

The study involving 661 children aged 6 months to under 18 years demonstrated that the high-dose quadrivalent influenza vaccine (IIV4-HD) is safe, with no serious adverse events reported and similar rates of mild reactions compared to the standard-dose vaccine.

IIV4-HD at a dose of 60 µg significantly improved immune responses, particularly in younger children (6 months to <3 years), showing higher antibody titers against various influenza strains compared to the standard-dose vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through Chang, LJ., Anderson, EJ., Jeanfreau, R., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Advances in the vaccination of the elderly against influenza: role of a high-dose vaccine. [2010]

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

Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial. [2020]

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

Fluzone® High-Dose Influenza Vaccine. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of high dose trivalent influenza vaccine in adults and immunosuppressed populations - A systematic review and meta-analysis. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through [2021]