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Virus Vaccine

aQIV for Flu

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 271
Awards & highlights

Study Summary

This study is evaluating whether a quadrivalent influenza vaccine with MF59 adjuvant is as effective as a licensed quadrivalent influenza vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 271
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 271 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Secondary outcome measures
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
+5 more
Other outcome measures
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)

Side effects data

From 2022 Phase 3 trial • 2044 Patients • NCT05044195
28%
Injection site pain
24%
Fatigue
20%
Headache
9%
Arthralgia
7%
Diarrhea
7%
Myalgia
5%
Chills
5%
Decreased appetite
4%
Nausea
3%
Erythema
3%
Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Comparator QIV
aQIV

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: aQIVExperimental Treatment1 Intervention
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
Group II: Comparator QIVActive Control1 Intervention
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aQIV
2021
Completed Phase 3
~2050

Find a Location

Who is running the clinical trial?

SeqirusLead Sponsor
59 Previous Clinical Trials
1,079,026 Total Patients Enrolled
Clinical Program DirectorStudy DirectorSeqirus
13 Previous Clinical Trials
74,082 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
2021. "A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05044195.
~584 spots leftby Apr 2025
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