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

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi Pasteur, a Sanofi Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

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.

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.

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 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 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}

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.

Treatment Details

Interventions

• High-Dose trivalent influenza vaccine (Virus Therapy)

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

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

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]

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]