aQIVc Vaccine for Flu in Adults 50+
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of the influenza vaccines (aQIVc, QIVr, or aQIV) and are monitored for immunogenicity and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
A subset of participants is monitored for long-term safety and immunogenicity
Treatment Details
Interventions
- aQIVc
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Who Is Running the Clinical Trial?
Seqirus
Lead Sponsor
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