What is the mechanism of action of this treatment?

The adjuvanted quadrivalent influenza vaccine (aQIVc) enhances the immune response by using an adjuvant, which boosts the body's immune reaction to the vaccine's antigens, leading to better protection against the flu. This is particularly important for high-risk groups, such as older adults, who may have a weaker immune response. Other common treatments include antiviral medications like oseltamivir, which inhibit the neuraminidase enzyme, preventing the virus from spreading within the body. These treatments are crucial as they reduce the severity and duration of flu symptoms, prevent complications, and decrease the spread of the virus.

What side effects are associated with this type of intervention?

Common side effects of adjuvanted and cell-based influenza vaccines, such as the adjuvanted quadrivalent influenza vaccine (aQIVc), include mild injection site reactions (pain, redness, swelling) and systemic reactions (headache, fatigue, muscle aches, fever). Serious adverse events are rare but can include allergic reactions like anaphylaxis. There is also an increased risk of syncope (fainting) post-vaccination, especially in adolescents. Overall, these vaccines are generally well-tolerated with most side effects being mild and transient.

What prior FDA approvals exist?

The FDA has approved several treatments for influenza, including vaccines and antiviral drugs. Among vaccines, adjuvanted options like the MF59-adjuvanted trivalent or quadrivalent vaccines have been approved to enhance immune responses, particularly in older adults. Cell-based vaccines, such as the cell culture-derived inactivated subunit influenza vaccines, have also been approved for their efficacy in preventing influenza. Antiviral drugs like zanamivir and laninamivir are approved for both treatment and prevention of influenza, offering additional options for managing the disease.

What other types of research exist?

Promising novel alternatives to aQIVc for flu patients in 2024 include: 1) mRNA-based influenza vaccines, which have shown potential for higher efficacy and rapid adaptability to circulating strains. 2) Recombinant protein-based vaccines, which offer a high degree of purity and targeted immune response. 3) Universal influenza vaccines, currently in development, aim to provide broader and longer-lasting protection against multiple influenza strains.

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Cancer Vaccine

aQIVc Vaccine for Flu in Adults 50+

Phase 3

Waitlist Available

Research Sponsored by Seqirus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Abnormal function of immune system due to known disorder or medication

Progressive, unstable, or uncontrolled clinical conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 365

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will study the safety & effectiveness of 3 flu vaccines in 7700 adults age 50+ with or without health conditions.

Who is the study for?

This trial is for adults aged 50 and older who are either healthy or have stable health issues that could make flu complications worse. They must be able to follow the study's procedures but can't join if they have immune problems, recent flu shots, Guillain-Barré syndrome, allergies to vaccine ingredients, or serious unstable conditions.

What is being tested?

The study tests three batches of a new flu vaccine called aQIVc against two existing vaccines (QIV1 and QIV2). Participants will be randomly assigned in specific ratios to receive one of these vaccines. The main goal is to compare how well each vaccine works and their safety over different periods up to one year.

What are the potential side effects?

Common side effects from flu vaccines include pain at the injection site, fatigue, headache, muscle pain, feverish feelings. Rarely there might be allergic reactions. Since this involves an investigational vaccine as well as licensed ones, unexpected side effects may also occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My immune system is not working properly due to a condition or medication.

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My health condition is getting worse or is not under control.

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I have a history of Guillain-Barré syndrome or a similar nerve condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immunogenicity Endpoint: Humoral immune responses of 3 lots of aQIVc compared in pairs in terms of Day 29 GMT ratio between each pair among the 3 lots, from antibody titers measured via HI assay.

Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 1 to Day 29 SCR and SCR difference, from antibody titers measured via HI assay.

Secondary study objectives

Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.

Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 vaccine in terms of Day 29 SCR and SCR difference, GMT and GMT ratio of antibodies measured via HI assay in subjects 65 years and older.

Immunogenicity Endpoints: For aQIVc and QIV1 vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.

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Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Investigational aQIVc groupExperimental Treatment1 Intervention

Group II: licensed QIV1 groupActive Control1 Intervention

Group III: licensed QIV2 groupActive Control1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The adjuvanted quadrivalent influenza vaccine (aQIVc) enhances the immune response by using an adjuvant, which boosts the body's immune reaction to the vaccine's antigens, leading to better protection against the flu. This is particularly important for high-risk groups, such as older adults, who may have a weaker immune response. Other common treatments include antiviral medications like oseltamivir, which inhibit the neuraminidase enzyme, preventing the virus from spreading within the body. These treatments are crucial as they reduce the severity and duration of flu symptoms, prevent complications, and decrease the spread of the virus.

Robust and prototypical immune responses toward influenza vaccines in the high-risk group of Indigenous Australians.Systematic review of the efficacy, effectiveness and safety of cell-based seasonal influenza vaccines for the prevention of laboratory-confirmed influenza in individuals ≥18 years of age.Effect of processed aloe vera gel on immunogenicity in inactivated quadrivalent influenza vaccine and upper respiratory tract infection in healthy adults: A randomized double-blind placebo-controlled trial.