aQIVc Vaccine for Flu in Adults 50+

No longer recruiting at 138 trial locations

Overseen By Use Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Seqirus

Must not be taking: Immunosuppressants

Disqualifiers: Uncontrolled conditions, Guillain-Barré, 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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new flu vaccine called aQIVc to evaluate its effectiveness and safety for individuals aged 50 and older. Researchers will compare this new vaccine with two existing vaccines to assess its efficacy. Participants will be divided into groups, each receiving one of the three vaccines. The trial seeks adults 50 and older who are healthy or have stable health conditions, such as diabetes or heart disease, which could increase flu risk. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking vaccine.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have an abnormal immune system function due to a known disorder or medication, you may not be eligible to participate.

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

Research has shown that the aQIVc vaccine is generally well-tolerated. In one study, adults aged 50 and older who received the aQIVc vaccine reported only a few side effects, most of which were mild, such as soreness at the injection site or slight fatigue. Serious side effects were rare.

These findings suggest that the aQIVc vaccine is safe for adults, even those with existing health issues that might increase their risk for flu complications. While this is encouraging, consulting a healthcare professional is advisable to determine if joining a trial is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard flu vaccines, which often use egg-based or live-attenuated virus formulations, the aQIVc vaccine being studied is a cell-culture-based quadrivalent inactivated vaccine. This method can potentially lead to a more consistent and faster production process, which is less affected by egg supply issues and mutations that can occur during egg-based vaccine production. Researchers are excited about aQIVc because it aims to improve immune response in adults aged 50 and over, who are often at higher risk for complications from the flu. This could mean a more effective vaccine option for an age group that is particularly vulnerable during flu season.

What evidence suggests that this trial's treatments could be effective for flu in adults 50+?

Research has shown that the aQIVc vaccine holds promise in preventing the flu. In this trial, participants will receive either the investigational aQIVc vaccine, the licensed aQIV vaccine, or the licensed QIVr vaccine. A previous study found that vaccines with added substances to boost the immune response, like aQIVc, work better than standard vaccines. In people aged 65 and over, similar vaccines reduced the chance of getting the flu by about 41%. Another study found that aQIVc was more effective than traditional egg-based vaccines. Overall, these findings suggest that aQIVc could be a strong option for flu prevention in older adults. ^{1 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 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.

Inclusion Criteria

Individuals who can comply with all study procedures

I am 50 or older with stable health conditions that could worsen with the flu.

Exclusion Criteria

Known hypersensitivity or allergy to any study vaccine component

I have received the flu vaccine in the last 6 months.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the influenza vaccines (aQIVc, QIVr, or aQIV) and are monitored for immunogenicity and safety

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 weeks

Multiple visits (in-person and virtual)

Extended Follow-up

A subset of participants is monitored for long-term safety and immunogenicity

up to 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• aQIVc

Trial Overview 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.

How Is the Trial Designed?

Group I: Investigational aQIVc group Experimental Treatment 1 Intervention

Group II: licensed aQIV group Active Control 1 Intervention

Group III: licensed QIVr group Active Control 1 Intervention

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

A randomised phase 2 immunogenicity and safety study of ... We report the results of a randomised proof-of-concept study, investigating the immunogenicity and safety of aQIVc.

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

Comparable effectiveness of MF59®-adjuvanted and high- ... The CDC reported an overall vaccine effectiveness (VE) of 46%. In adults aged ≥65 years, absolute vaccine effectiveness was 41% (95% CI, 36-46%) in outpatient ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11951413/

Enhanced influenza vaccines impact effectiveness in ... Compared with the standard-dose QIV (33%; 95% confidence interval (CI): 24–41), the adjuvanted QIV was significantly more effective, with overall VE estimates ...

4. cslseqirus.us cslseqirus.us/news/csl-seqirus-presents-real-world-evidence-at-options-xii-conference

CSL Seqirus Presents Real-World Evidence at OPTIONS ... Results from a review of the 2017 to 2020 influenza seasons revealed a higher relative effectiveness of QIVc over QIVe/egg-based trivalent (TIVe) ...

5. cdc.gov cdc.gov/mmwr/volumes/73/rr/rr7305a1.htm

Prevention and Control of Seasonal Influenza with Vaccines The rate of waning effectiveness observed in these studies varied considerably and waning effects were inconsistent across age groups, seasons, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04782323

Study Details | NCT04782323 | Safety and Immunogenicity ... Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years. ...

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

Immunogenicity and Safety of MF59-Adjuvanted ... Adults aged 50–64 years have a high incidence of symptomatic influenza associated with substantial disease and economic burden each year.

8. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-aqivc-hd-vaccine-compared-to-a-drug-combination-for-adults-50-years-and-older-at-risk-of-flu-complications/

Study on the Safety and Immune Response of aQIVc HD ... This clinical trial tests the safety and immune response of the aQIVc HD influenza vaccine in adults aged 50 and older who are at risk of ...

9. withpower.com withpower.com/trial/phase-3-influenza-human-9-2023-4b8a7

aQIVc Vaccine for Flu in Adults 50+ This Phase 3 medical study run by Seqirus needs participants to evaluate whether aQIVc will have tolerable side effects & efficacy for patients with Flu and ...