aQIVc Vaccine for Flu in Adults 50+

Recruiting at 134 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

7741 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIVr, or aQIV in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIVr, and aQIV). The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.

Research Team

Clinical Program Director

Principal Investigator

Seqirus

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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