Influenza, HumanPhase 3NCT05044195

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

A Phase 3 study testing aQIV and Comparator QIV in people with Influenza, Human, run by Seqirus at 29 sites in 3 countries.

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, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age. Read more about this study

Who is it for?: Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: aQIV and Comparator QIV
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,044 participants
Where: 29 sitesin 3 countries
Study dates: 30 Sep 2021to 9 Sep 2022
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 50 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

In order to participate in this study, all subjects must meet ALL of the following inclusion criteria:
Individuals 50 to 64 years of age (i.e. 50 to ≤64 years) on the day of informed consent
Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
Individuals who can comply with study procedures including follow-up
Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination

Who cannot join

In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the study vaccination
Progressive, unstable or uncontrolled clinical conditions
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
History of any medical condition considered an AESI
Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis

Show all 19Show fewer

Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Abnormal function of the immune system resulting from:
Clinical conditions
Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to ≥20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also permitted
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent
Received immunoglobulins or any blood products within 180 days prior to informed consent
Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (notes: i. concomitant participation in a study not involving or no longer involving administration of drugs, vaccines, or medical devices, is acceptable (e.g. studies in safety follow-up phase, observational studies); ii. concomitant participation in a COVID-19 vaccine study is acceptable provided that the vaccine dosing interval mentioned in Exclusion Criterion #11 is adhered to)
Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine during the study period
Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination
Receipt of any inactivated non-influenza vaccine within 14 days or live-attenuated vaccine within 28 days prior to enrollment in this study or plan to receive any other non-influenza vaccine within 28 days from study vaccination
Acute (severe) febrile illness
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
Study personnel or immediate family members or household member of study personnel

Trial locations and contacts

29 sites in 3 countries.

Country

City, postcode or hospital

29 sites in 3 countries

United States12 sites

84005 JEM Research Institute
Atlantis, Florida, 33462
84008 United Medical Associates
Binghamton, New York, 13901
84011 Meridian Clinical Research
Endwell, New York, 13760
84006 Alliance for Multispecialty Research
Kansas City, Missouri, 64114
84009 Meridian Clinical Research
Lincoln, Nebraska, 68510
84013 Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
84002 Meridian Clinical Research
Norfolk, Nebraska, 68701
84004 Meridian Clinical Research
Omaha, Nebraska, 68134
84010 Headlands Research Orlando
Orlando, Florida, 32819
84001 Meridian Clinical Research
Savannah, Georgia, 31406
84003 Meridian Clinical Research
Sioux City, Iowa, 51106
84007 Alliance for Multispecialty Research
Tempe, Arizona, 85281

Other trials in United States

Germany11 sites

27602 Klinische Forschung Berlin
Berlin
27603 Emovis GmbH
Berlin
27608 Klinische Forschung Dresden GmbH
Dresden
27609 IKF Pneumologie GmbH & Co. KG
Frankfurt
27611 Siteworks GmbH
Fulda
27601 Klinische Forschung Hamburg GmbH
Hamburg
27605 Clinical Research Hamburg GmbH
Hamburg
27604 Klinische Forschung Hannover-Mitte GmbH
Hanover
27607 Siteworks GmbH
Hanover
27606 SIBAmed GmbH & Co KG
Leipzig
27610 Studienzentrum Leitz Triderm
Stuttgart

Other trials in Germany

Estonia6 sites

23302 Vee Family Doctors Centre
Paide
23301 Innomedica OÜ - Outpatient
Tallinn
23303 Al Mare Perearstikeskus OÜ
Tallinn
23304 Merelahe Family Doctors Centre
Tallinn
23306 Center for Clinical and Basic Research
Tallinn
23305 Clinical Research Center - Vaccine Trials
Tartu

Other trials in Estonia

About this study

Official title: A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comparison With a Licensed Quadrivalent Influenza Vaccine, in Adults 50 to 64 Years of Age

Conditions: Influenza, Human
Being tested: aQIV, Comparator QIV
Keywords: Influenza, Vaccine, MF59 adjuvant
Medical subject headings: Influenza, Human

What participants receive

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

aQIVBiological
Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
Comparator QIVBiological
Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1

Study groups in NCT05044195
Study group	Role	What they receive
aQIV	Experimental	Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains Receives: Biological: aQIV
Comparator QIV	Active comparator	Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains Receives: Biological: Comparator QIV

What is being measured

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

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
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Measured: Day 22
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The SCR defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.
The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.
Measured: Day 1 to Day 22
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
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Measured: Day 22

Secondary outcomes (8)

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
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Measured: Day 181
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
GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains
Measured: Day 1 to Day 181
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
The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer.
Measured: Day 1 to Day 181
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains
Measured: Day 1 to Day 181
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The SCR defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.
Measured: Day 1 to Day 181
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination
Measured: Day 1 through Day 7
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs.
Measured: Day 1 through Day 22
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
The percentage of subjects with any SAE, AE leading to withdrawal, or AESI during the study period
Measured: Day 1 through Day 271

Timeline

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

30 Sep 20219 Sep 2022

First posted14 Sep 2021
Study start30 Sep 2021
Primary completion18 Jan 2022
Study completion9 Sep 2022

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.
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: 2,044 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05044195
Sponsor's protocol ID: V118_23
Status last verified: May 2023
First submitted: 6 Sep 2021
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \[EU CTR\])).

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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comparison With a Licensed Quadrivalent Influenza Vaccine, in Adults 50 to 64 Years of Age
ClinicalTrials.gov ID: NCT05044195
Acronym / sponsor ID: V118_23
Conditions: Influenza, Human
Keywords: Influenza, Vaccine, MF59 adjuvant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,044 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: 30 Sep 2021 (actual)
Primary completion: 18 Jan 2022 (actual)
Study completion: 9 Sep 2022 (actual)
First posted: 14 Sep 2021 (actual)
Results: Posted 28 Sep 2023

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: 2

Arm	Type	Receives
aQIV	Experimental	Biological: aQIVAdjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV	Active comparator	Biological: Comparator QIVNon-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains

Who may qualify

Ages: 50 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

In order to participate in this study, all subjects must meet ALL of the following inclusion criteria:
Individuals 50 to 64 years of age (i.e. 50 to ≤64 years) on the day of informed consent
Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
Individuals who can comply with study procedures including follow-up
Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination

Key exclusion criteria (19 listed)

In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the study vaccination
Progressive, unstable or uncontrolled clinical conditions
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
History of any medical condition considered an AESI

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
aQIVParticipants receive a 0.5-mL intramuscular dose of aQIV on Day 1	Biological	aQIV
Comparator QIVParticipants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1	Biological	Comparator QIV

Primary outcome

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
Time frame: Day 22
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Time frame: Day 1 to Day 22
The SCR defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.
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
Time frame: Day 22
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.

8 secondary outcomes

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
Time frame: Day 181
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
Time frame: Day 1 to Day 181
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
Time frame: Day 1 to Day 181
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Time frame: Day 1 to Day 181
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Time frame: Day 1 to Day 181
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
Time frame: Day 1 through Day 7
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
Time frame: Day 1 through Day 22
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
Time frame: Day 1 through Day 271

Results and safety

Results posted to the registry on 28 Sep 2023, 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	1,027	982
Comparator QIV	1,017	989

Primary outcome: 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

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

Measure	aQIV n = 983	Comparator QIV n = 985
A/H1N1	731.90 (689.39 to 777.04)	586.85 (552.83 to 622.96)
A/H3N2	347.89 (324.78 to 372.64)	313.16 (292.42 to 335.36)
B/Yamagata	154.40 (146.80 to 162.40)	145.74 (138.57 to 153.27)
B/Victoria	144.41 (136.97 to 152.26)	143.32 (135.97 to 151.07)

aQIV vs Comparator QIV: GMT ratio: 0.802 (95% CI 0.738 to 0.871)
aQIV vs Comparator QIV: GMT ratio: 0.900 (95% CI 0.819 to 0.989)
aQIV vs Comparator QIV: GMT ratio: 0.944 (95% CI 0.880 to 1.012)

Population analysed: Per Protocol Set (PPS) Immunogenicity, defined as all subjects in the Full Analysis Set (FAS) Immunogenicity who: had both Day 1 and Day 22 immunogenicity assessment; correctly received the vaccine (ie, received the vaccine to which the subjects were randomized and at the scheduled time points); had no protocol deviations leading to exclusion as defined prior to unblinding/analysis; were not excluded due to other reasons defined prior to unblinding or analysis. Note: Adjusted GMTs are presented.

Primary outcome: Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

Time frame: Day 1 to Day 22. Number (95% Confidence Interval). Unit: percentage of participants

Measure	aQIV n = 983	Comparator QIV n = 985
A/H1N1	81.2 (78.57 to 83.58)	76.8 (74.04 to 79.42)
A/H3N2	63.6 (60.46 to 66.63)	61.8 (58.61 to 64.82)
B/Yamagata	43.4 (40.27 to 46.60)	41.0 (37.92 to 44.19)
B/Victoria	44.5 (41.39 to 47.74)	40.6 (37.52 to 43.76)

aQIV vs Comparator QIV: SCR difference: -4.4 (95% CI -7.97 to -0.74)
aQIV vs Comparator QIV: SCR difference: -1.8 (95% CI -6.14 to 2.48)
aQIV vs Comparator QIV: SCR difference: -2.4 (95% CI -6.77 to 2.00)

Population analysed: PPS Immunogenicity

Primary outcome: 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

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

Measure	aQIV n = 1027	Comparator QIV n = 1016
A/H1N1	729.17 (687.51 to 773.36)	589.07 (555.25 to 624.94)
A/H3N2	347.09 (324.44 to 371.33)	315.69 (295.04 to 337.79)
B/Yamagata	155.19 (147.67 to 163.09)	146.89 (139.74 to 154.40)
B/Victoria	143.73 (136.44 to 151.42)	143.74 (136.42 to 151.45)

aQIV vs Comparator QIV: GMT ratio: 0.808 (95% CI 0.745 to 0.876)
aQIV vs Comparator QIV: GMT ratio: 0.910 (95% CI 0.829 to 0.998)
aQIV vs Comparator QIV: GMT ratio: 0.947 (95% CI 0.884 to 1.014)

Population analysed: FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received study vaccination and provided immunogenicity data at any time point. Note: Adjusted GMTs are presented.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aQIV	31 of 1,027 (3%)	660 of 1,020 (64.7%)	1 of 1,027
Comparator QIV	31 of 1,016 (3.1%)	519 of 1,008 (51.5%)	0 of 1,016

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])).

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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 Program Director study director

Seqirus

29 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aQIV and Comparator QIV in people with Influenza, Human, run by Seqirus at 29 sites in 3 countries.

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 5 inclusion and 19 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Germany, Estonia. 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 28 Sep 2023). 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: 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 (time frame: Day 22). The study lists 3 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 NCT05044195.

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 28 Sep 2023.