Influenza, HumanPhase 3NCT03314662

Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults

A Phase 3 study testing MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV), Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) and MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2) in people with Influenza, Human, run by Seqirus at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV), Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) and MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,778 participants
Where: 20 sitesUnited States
Study dates: 17 Oct 2017to 17 May 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Males and females ≥ 65 years old who are healthy or have co-morbidities
Individuals who or whose legal representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
Ability to attend all scheduled visits and to comply with study procedures including diary card completion and follow-up

Who cannot join

History of behavioral or cognitive impairment or psychiatric condition
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
Abnormal function of the immune system
Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
Any other clinical condition that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
Additional eligibility criteria may be discussed by contacting the site.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Anaheim Clinical Trials
Anaheim, California, 92801
United Medical Associates
Binghamton, New York, 13901
Medical Research South
Charleston, South Carolina, 29407
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Clinical Research of South Florida, an AMR Company
Coral Gables, Florida, 33134
Benchmark Research
Fort Worth, Texas, 76135
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Advanced Clinical Research
Meridian, Idaho, 83642
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Heartland Research Associates, LLC - An AMR Company
Newton, Kansas, 67114
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Paradigm clinical Research Centers, Inc
Redding, California, 96001
Benchmark Research
San Angelo, Texas, 76904
Meridan Clinical Research, LLC
Savannah, Georgia, 31406
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Martin Diagnostic Clinic
Tomball, Texas, 77375
Advanced Clinical Research
West Jordan, Utah, 84088
Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Controlled, Multicenter, Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Influenza Vaccine in Comparison With an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine and an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine Containing the Alternate B Strain, in Adults Aged 65 Years and Above

Conditions: Influenza, Human
Being tested: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV), Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1), MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)Biological
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)Biological
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)Biological
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).

Study groups in NCT03314662
Study group	Role	What they receive
aQIV	Experimental	MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. Receives: Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
aTIV-1	Experimental	Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Receives: Biological: Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)
aTIV-2	Experimental	MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. Receives: Biological: MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)

What is being measured

The primary outcome is the main question the study is designed to answer.

Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.
The GMT of the post-vaccination (Day 22) hemagglutination inhibition (HI) titer. The GMT ratio was defined as the GMT for aTIV-1 (or aTIV-2) over the GMT for aQIV for all of the four strains.
Measured: Day 22
Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis
The SCR is defined as the percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >= 1:40 or a pre-vaccination HI titer >= 1:10 and a >= 4-fold increase in post-vaccination HI titer. The SCR Difference is defined as the difference between the SCR of post- vaccination (Day 22) HI titer for aTIV-1 (or aTIV-2) and the SCR of post-vaccination (Day 22) HI titer for aQIV. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2.
Measured: Day 22
Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.
The percentage of subjects vaccinated with aQIV achieving SCR at Day 22 was assessed for each of the 4 strains. SCR was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination HI titer ≥1:40 or a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in post-vaccination HI titer. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving SCR for HI antibody should meet or exceed 30%.
Measured: Day 22
Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.
The percentage of subjects vaccinated with aQIV achieving HI antibody titers ≥ 1:40 at Day 22 was assessed for each of the 4 strains. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving a post-vaccination HI antibody titer ≥ 1:40 should meet or exceed 60%.
Measured: Day 22

Secondary outcomes (7)

Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
For the assessment of GMTs using HI assay, aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2.
The immunologic superiority in HI antibody responses for the alternate B strain (eg, the influenza B strain included in the aQIV but not in the aTIV formulation) were assessed for each aTIV separately, using the GMT ratio (aTIV/aQIV) at Day 22.
Measured: Day 1 and Day 22
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains
The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1). aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2.
Measured: Day 22/Day 1
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
The percentage of subjects with HI titer of ≥1:40 at Day 1 (prevaccination) and Day 22 (postvaccination) was assessed for homologous strains. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2.
Measured: Day 1 and Day 22
Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains
The SCR was defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination HI titer ≥1:40 or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. For assessment if SCR using HI assay, aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2.
The immunologic superiority in HI antibody responses for the alternate B strain (eg, the influenza B strain included in the aQIV but not in the aTIV formulation) were assessed for each aTIV separately, using the difference in SCR (aTIV-aQIV) at Day 22.
Measured: Day 22
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination
Safety of vaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
Measured: Day 1 through Day 7
Safety Endpoint: Number of Subjects With Unsolicited AEs
Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
Measured: Day 1 through Day 22
Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs)
Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs and medically attended AE up to 180 days after vaccination.
Measured: Day 1 through Day 181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201717 May 2018

First posted19 Oct 2017
Study start17 Oct 2017
Primary completion11 Dec 2017
Study completion17 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza, HumanStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,778 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03314662
Sponsor's protocol ID: V118_20
Status last verified: Jul 2020
First submitted: 16 Oct 2017
Last updated: 22 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Essink B, Fierro C, Rosen J, Figueroa AL, Zhang B, Verhoeven C, Edelman J, Smolenov I. Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults. Vaccine. 2020 Jan 10;38(2):242-250. doi: 10.1016/j.vaccine.2019.10.021. Epub 2019 Oct 18.
PubMed 31635976

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Controlled, Multicenter, Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Influenza Vaccine in Comparison With an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine and an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine Containing the Alternate B Strain, in Adults Aged 65 Years and Above
ClinicalTrials.gov ID: NCT03314662
Acronym / sponsor ID: V118_20
Conditions: Influenza, Human
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,778 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: 17 Oct 2017 (actual)
Primary completion: 11 Dec 2017 (actual)
Study completion: 17 May 2018 (actual)
First posted: 19 Oct 2017 (actual)
Results: Posted 22 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
aQIV	Experimental	Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.
aTIV-1	Experimental	Biological: Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.
aTIV-2	Experimental	Biological: MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Males and females ≥ 65 years old who are healthy or have co-morbidities
Individuals who or whose legal representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
Ability to attend all scheduled visits and to comply with study procedures including diary card completion and follow-up

Key exclusion criteria (6 listed)

History of behavioral or cognitive impairment or psychiatric condition
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
Abnormal function of the immune system
Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
Any other clinical condition that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.	Biological	aQIV
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.	Biological	aTIV-1
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).	Biological	aTIV-2

Primary outcome

Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.
Time frame: Day 22
The GMT of the post-vaccination (Day 22) hemagglutination inhibition (HI) titer. The GMT ratio was defined as the GMT for aTIV-1 (or aTIV-2) over the GMT for aQIV for all of the four strains.
Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis
Time frame: Day 22
The SCR is defined as the percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >= 1:40 or a pre-vaccination HI titer >= 1:10 and a >= 4-fold increase in post-vaccination HI titer. The SCR Difference is defined as the difference between the SCR of post- vaccination (Day 22) HI titer for aTIV-1 (or aTIV-2) and the SCR of post-vaccination (Day 22) HI titer for aQIV. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2.
Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.
Time frame: Day 22
The percentage of subjects vaccinated with aQIV achieving SCR at Day 22 was assessed for each of the 4 strains. SCR was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination HI titer ≥1:40 or a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in post-vaccination HI titer. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving SCR for HI antibody should meet or exceed 30%.
Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.
Time frame: Day 22
The percentage of subjects vaccinated with aQIV achieving HI antibody titers ≥ 1:40 at Day 22 was assessed for each of the 4 strains. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving a post-vaccination HI antibody titer ≥ 1:40 should meet or exceed 60%.

7 secondary outcomes

Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
Time frame: Day 1 and Day 22
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains
Time frame: Day 22/Day 1
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
Time frame: Day 1 and Day 22
Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains
Time frame: Day 22
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination
Time frame: Day 1 through Day 7
Safety Endpoint: Number of Subjects With Unsolicited AEs
Time frame: Day 1 through Day 22
Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs)
Time frame: Day 1 through Day 181

Results and safety

Results posted to the registry on 22 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
aQIV	889	881
aTIV-1	445	440
aTIV-2	444	439

Primary outcome: Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.

Time frame: Day 22. Geometric mean (95% Confidence Interval). Unit: Geometric mean titer

Measure	aQIV n = 872	aTIV-1 n = 436	aTIV-2 n = 433	aTIV-1/aTIV-2 n = 869
A/H1N1	65.01 (57.79 to 73.13)	NA (NA to NA)	NA (NA to NA)	75.16 (66.68 to 84.72)
A/H3N2	294.91 (261.88 to 332.09)	NA (NA to NA)	NA (NA to NA)	293.31 (259.91 to 330.99)
B/Yamagata	24.67 (22.67 to 26.84)	15.96 (14.48 to 17.59)	24.30 (22.00 to 26.84)	NA (NA to NA)
B/Victoria	30.78 (28.27 to 33.51)	30.13 (27.31 to 33.24)	21.80 (19.73 to 24.09)	NA (NA to NA)

aQIV vs aTIV-1 vs aTIV-2: GMT ratio (aTIV/aQIV): 1.16 (95% CI 1.05 to 1.27)
aQIV vs aTIV-1 vs aTIV-2: GMT ratio: (aTIV/aQIV: 0.99 (95% CI 0.90 to 1.09)
aQIV vs aTIV-1 vs aTIV-2: GMT ratio: aTIV/aQIV: 0.99 (95% CI 0.90 to 1.08)

Population analysed: The per protocol set (PPS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results

Primary outcome: Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis

Time frame: Day 22. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	aQIV n = 872	aTIV-1 n = 436	aTIV-2 n = 433
A/H1N1	35.21 (32 to 38.5)	39.45 (34.8 to 44.2)	37.41 (32.8 to 44.2)
A/H3N2	39.33 (36.1 to 42.7)	39.70 (36.4 to 43.0)	37.18 (32.6 to 41.9)
B/Yamagata	16.4 (14.0 to 19.0)	NA (NA to NA)	15.47 (12.2 to 19.2)
B/Victoria	13.42 (11.2 to 15.9)	12.16 (9.24 to 15.6)	NA (NA to NA)

aQIV vs aTIV-1 vs aTIV-2: SCR difference (aTIV minus aQIV): 3.23 (95% CI -1.30 to 7.76)
aQIV vs aTIV-1 vs aTIV-2: SCR difference (aTIV minus aQIV): 0.37 (95% CI -4.23 to 4.96)
aQIV vs aTIV-1 vs aTIV-2: SCR difference (aTIV minus aQIV)]: -0.93 (95% CI -5.13 to 3.27)

Primary outcome: Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.

Time frame: Day 22. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	aQIV n = 872	aTIV-1 n = 436	aTIV-2 n = 433
A/H1N1	35.21 (32.03 to 38.48)	39.45 (34.80 to 44.20)	37.41 (32.8 to 40.20)
A/H3N2	39.33 (36.08 to 42.67)	39.70 (36.43 to 43.04)	37.18 (32.6 to 41.9)
B/Yamagata	16.40 (14.0 to 19.03)	NA (NA to NA)	15.47 (12.2 to 19.2)
B/Victoria	13.42 (11.22 to 15.86)	12.16 (9.24 to 15.60)	NA (NA to NA)

Population analysed: The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results.

Primary outcome: Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.

Time frame: Day 22. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	aQIV n = 872	aTIV-1 n = 436	aTIV-2 n = 433
A/H1N1	69.38 (66.20 to 72.43)	71.79 (67.31 to 75.97)	68.82 (64.23 to 73.16)
A/H3N2	93.92 (92.12 to 95.41)	94.72 (92.19 to 96.63)	94.92 (92.41 to 96.79)
B/Yamagata	32.80 (29.69 to 36.03)	21.79 (18.00 to 25.96)	36.95 (32.39 to 41.69)
B/Victoria	38.19 (34.95 to 41.51)	36.93 (32.38 to 41.65)	24.48 (20.50 to 28.81)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aQIV	37 of 888 (4.2%)	461 of 888 (51.9%)	2 of 888
aTIV-1	28 of 444 (6.3%)	217 of 444 (48.9%)	0 of 444
aTIV-2	18 of 444 (4.1%)	215 of 444 (48.4%)	0 of 444

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31635976Essink B, Fierro C, Rosen J, Figueroa AL, Zhang B, Verhoeven C, Edelman J, Smolenov I. Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults. Vaccine. 2020 Jan 10;38(2):242-250. doi: 10.1016/j.vaccine.2019.10.021. Epub 2019 Oct 18.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Scientist study director

Seqirus

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. (time frame: Day 22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314662, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.