Adjuvanted Flu Vaccine for Flu

Recruiting at 321 trial locations

Overseen By Use Central Contact

Age: 65+

Sex: Any

Trial Phase: Phase 3

Sponsor: Seqirus

Must not be taking: Corticosteroids, Antineoplastics

Disqualifiers: Bedridden, Guillain-Barré, Immune dysfunction, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 1

35800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of flu vaccines to determine which better prevents the flu in older adults. One vaccine, known as aQIV or aTIV, includes an adjuvant, which may enhance the body's response, while the other does not. The researchers aim to discover if the adjuvanted vaccine is more effective for those 65 and older. Individuals who are 65 or older, not bedridden, and haven't recently received a flu shot may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to research that could lead to a new, effective flu vaccine for older adults.

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

The trial does not specify if you need to stop taking your current medications. However, if you are taking certain medications like high-dose corticosteroids or immunomodulating agents, you may not be eligible to participate.

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

Research shows that the MF59-adjuvanted flu vaccine is generally safe. Studies indicate that serious side effects are rare, though some individuals might experience a mild to moderate fever more frequently with this vaccine. The vaccine triggers a strong immune response, indicating its effectiveness. People with severe allergies to flu vaccines or certain ingredients should avoid this vaccine. Overall, evidence suggests this vaccine is safe for most individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about these treatments because they use an adjuvant, MF59, which boosts the immune response to the influenza vaccine. Unlike standard flu vaccines that don't contain an adjuvant, these adjuvanted vaccines may provide enhanced protection by stimulating a stronger immune response. This approach is particularly promising for those with weaker immune systems, like the elderly, as it could lead to better efficacy and broader protection against the flu.

What evidence suggests that this trial's treatments could be effective for flu prevention in adults ≥65 years of age?

Research has shown that the MF59-adjuvanted flu vaccine (aQIV or aTIV), which participants in this trial may receive, offers better protection for older adults than regular flu vaccines. Studies have found that this vaccine reduces the likelihood of hospital visits due to the flu and other respiratory issues. It performs as effectively as high-dose vaccines in preventing the flu for those aged 65 and older. The vaccine contains an adjuvant that enhances the body's immune response, offering stronger protection. This is particularly important for older individuals, whose immune systems may not respond as effectively to standard vaccines. ^{3 6 7 8 9}

Who Is on the Research Team?

Clinical Program Director

Principal Investigator

Seqirus

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older who are willing to give written consent and can follow the study procedures. It's designed to see if a new adjuvanted flu vaccine works better than the regular non-adjuvanted one.

Inclusion Criteria

To be eligible for this study, all participants must fulfill the specified requirements.

I am 65 years old or older.

Participants must have provided written consent demonstrating they understand the study's parameters in accordance with local regulations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive either the MF59-adjuvanted or non-adjuvanted influenza vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for RT-PCR-confirmed influenza and immunogenicity

Approximately 6 months

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• aQIV or aTIV

Trial Overview The study compares an MF59-adjuvanted influenza vaccine (either aQIV or aTIV) with a standard, non-adjuvanted flu vaccine (QIV or TIV). Participants will be randomly assigned to receive one of these vaccines in order to test effectiveness against the flu.

How Is the Trial Designed?

Group I: Non-adjuvanted influenza vaccine Experimental Treatment 1 Intervention

Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or Non-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain

Group II: MF59-adjuvanted influenza vaccine Experimental Treatment 1 Intervention

MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or MF59-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain

Who Is Running the Clinical Trial?

Seqirus

Lead Sponsor

Trials

60

Recruited

1,081,000+

Dr. Paul McKenzie

Seqirus

Chief Executive Officer since 2023

PhD in Engineering

Dr. Gregg Sylvester

Seqirus

Chief Health Officer since 2016

MD from Albany Medical College, MPH from Johns Hopkins Bloomberg School of Public Health

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11033326/

Relative Effectiveness of the MF59®‐Adjuvanted Influenza ... Relative to both HD‐IIV3e and IIV4e, aIIV3 provided improved protection from cardiorespiratory or influenza hospitalizations.

2. academic.oup.com academic.oup.com/ofid/article/11/8/ofae459/7734202

Relative Effectiveness of the MF59-Adjuvanted Influenza ... This study demonstrated comparable effectiveness of aTIV and HD-TIV among individuals with no identified risk factors and higher effectiveness of aTIV compared ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1201971225002073

Comparable effectiveness of MF59®-adjuvanted and high- ... In summary, we found that aQIV and HD-QIV had comparable effectiveness in the prevention of test-confirmed influenza in adults aged ≥65 years during the 2022- ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39946829/

A randomised phase 2 immunogenicity and safety study of ... Vaccination effectiveness is often lower in elderly individuals. By adding an adjuvant and using cell-based vaccine production methods, the MF59 ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0310677

Immunogenicity and safety of the MF59-adjuvanted seasonal ... Efficacy was defined as reduction in the risk of influenza in individuals immunized with aTIV/aQIV, compared with placebo/non-influenza vaccines ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7360101/

Immunogenicity and Safety of an MF59-adjuvanted ... Severe local and systemic AEs were rare. Rates of mild-to-moderate fever appeared to be higher in aIIV4 vaccinees; in high-risk subjects, 15% and 9.6% of aIIV4 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X14017289

Safety and effectiveness of MF-59 adjuvanted influenza ... MF-59 adjuvanted influenza vaccines have demonstrated superior immunogenicity against both homologous and heterologous strains in both children and adults.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10611124/

Immunogenicity and Safety of MF59-Adjuvanted ... The study showed the adjuvanted vaccine is safe and well tolerated and able to produce a strong immune response. Functional antibody responses ...

9. cdc.gov cdc.gov/flu/vaccine-types/adjuvant.html

Adjuvanted Flu Vaccine | Influenza (Flu) Fluad should not be given to people with a history of severe allergic reaction to any flu vaccine or to vaccine ingredients other than eggs.