InfluenzaPhase 2NCT04576702

Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

A Phase 2 study testing Investigational aIIV4c, IIV4c and aIIV4 in people with Influenza and Human, run by Seqirus at 21 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

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: Investigational aIIV4c, IIV4c and aIIV4
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 471 participants
Where: 21 sitesUnited States
Study dates: 8 Oct 2020to 24 May 2021
Phase: Phase 2
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals 50 years of age and older 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

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 informed consent 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 adverse event of special interest.
Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.

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Abnormal function of the immune system resulting from:
Clinical conditions
Systemic administration of corticosteroids (PO/IV/IM) at a dose of ≥ 20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5.
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 vaccination.
Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
Study personnel or immediate family or household member of study personnel.
Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period.
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.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

4007 - Regional Clinical Research / United Medical Associates
Binghamton, New York, 13901
4023 - Advanced Clinical Research
Boise, Idaho, 83642
4004 - Sterling research
Cincinnati, Ohio, 45219
4017 - Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
4006 - Westside Center for Clinical Research
Jacksonville, Florida, 32205
4013 - Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
4008 - The Center for Pharmaceutical Research, an AMR company
Kansas City, Missouri, 64114
4014 - Medpharmi
Kenner, Louisiana, 70065
4001 - Central Kentucky Research Associates, an AMR company
Lexington, Kentucky, 40509
4022 - Coastal Clinical Research, an AMR company
Mobile, Alabama, 36608
4010 - Heartland Research Associates, LLC
Newton, Kansas, 67114
4021 - Research Centers of America, LLC
Oakland, Florida, 33334
4011 - Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
4009 - Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
4012 - M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
4005 - Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
4024 - Sundance Clinical Research, LLC
St Louis, Missouri, 63141
4002 - Clinical Research Consortium, an AMR company
Tempe, Arizona, 85283
4018 - Martin Diagnostic Clinic
Tomball, Texas, 77375
4020 - Advanced Clinical Research
West Jordan, Utah, 84088
4016 - Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Stratified, Observer-Blind Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Older Adults

This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serum.

Conditions: Influenza, Human
Being tested: Investigational aIIV4c, IIV4c, aIIV4, RIV4
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.

Investigational aIIV4cBiological
Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
IIV4cBiological
Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
aIIV4Biological
Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
RIV4Biological
Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.

Study groups in NCT04576702
Study group	Role	What they receive
Investigational aIIV4c group	Experimental	aIIV4c will be administered as a single dose intramuscularly on Day 1 Receives: Biological: Investigational aIIV4c
licensed IIV4c group	Active comparator	IIV4c will be administered as a single dose intramuscularly on Day 1 Receives: Biological: IIV4c
licensed aIIV4 group	Active comparator	aIIV4 will be administered as a single dose intramuscularly on Day 1 Receives: Biological: aIIV4
licensed RIV4 group	Active comparator	RIV4 will be administered as a single dose intramuscularly on Day 1 Receives: Biological: RIV4

What is being measured

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

Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses
Measured: 28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses
Measured: 28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Measured: 28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses
Measured: 28 days post-vaccination

Secondary outcomes (11)

Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions
The percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination.
Measured: 7 days post-vaccination
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29.
Related AEs = considered at least possibly related to study vaccination by the investigator.
Measured: 28 days post-vaccination
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Measured: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses
Measured: 28 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses
Measured: 28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Measured: 28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses
Measured: 180 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses
Measured: 180 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses
Measured: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses
Measured: 180 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses
Measured: 180 days post-vaccination

Timeline

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

8 Oct 202024 May 2021

First posted6 Oct 2020
Study start8 Oct 2020
Primary completion19 Mar 2021
Study completion24 May 2021

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 InfluenzaStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 471 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04576702
Sponsor's protocol ID: V200_10
Status last verified: Apr 2024
First submitted: 17 Sep 2020
Last updated: 17 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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 Common Technical Documents (CTD) modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (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 \[EU CTR\])

Publications

Essink BJ, Vermeulen W, Andrade C, de Rooij R, Isakov L, Casula D, Albano FR. A randomised phase 2 immunogenicity and safety study of a MF59-adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine (aQIVc) in adults aged 50 years and older. Vaccine. 2025 Apr 2;51:126791. doi: 10.1016/j.vaccine.2025.126791. Epub 2025 Feb 12.
PubMed 39946829

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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Stratified, Observer-Blind Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Older Adults
ClinicalTrials.gov ID: NCT04576702
Acronym / sponsor ID: V200_10
Conditions: Influenza, Human
Keywords: Influenza, Vaccine, MF59, Adjuvant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 471 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: 8 Oct 2020 (actual)
Primary completion: 19 Mar 2021 (actual)
Study completion: 24 May 2021 (actual)
First posted: 6 Oct 2020 (actual)
Results: Posted 17 Apr 2024

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: 4

Arm	Type	Receives
Investigational aIIV4c group	Experimental	Biological: Investigational aIIV4caIIV4c will be administered as a single dose intramuscularly on Day 1
licensed IIV4c group	Active comparator	Biological: IIV4cIIV4c will be administered as a single dose intramuscularly on Day 1
licensed aIIV4 group	Active comparator	Biological: aIIV4aIIV4 will be administered as a single dose intramuscularly on Day 1
licensed RIV4 group	Active comparator	Biological: RIV4RIV4 will be administered as a single dose intramuscularly on Day 1

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Individuals 50 years of age and older 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 (17 listed)

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 informed consent 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 adverse event of special interest.
Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.

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
Investigational aIIV4cInvestigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.	Biological	Investigational aIIV4c group
IIV4cLicensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Biological	licensed IIV4c group
aIIV4Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Biological	licensed aIIV4 group
RIV4Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.	Biological	licensed RIV4 group

Primary outcome

Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination

11 secondary outcomes

Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions
Time frame: 7 days post-vaccination
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
Time frame: 28 days post-vaccination
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Time frame: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination

Results and safety

Results posted to the registry on 17 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational aIIV4c Group	116	112
Licensed IIV4c Group	119	114
Licensed aIIV4 Group	116	112
Licensed RIV4 Group	120	116

Primary outcome: Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses

Time frame: 28 days post-vaccination. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Investigational aIIV4c Group n = 110	Licensed IIV4c Group n = 114	Licensed aIIV4 Group n = 109	Licensed RIV4 Group n = 116
A/H1N1 Day 1 HI GMT	19.5 (15.5 to 24.5)	17.04 (13.6 to 21.3)	21.85 (17.4 to 27.5)	18.05 (14.5 to 22.5)
A/H1N1 Day 29 HI GMT	146.05 (116.1 to 183.7)	111.38 (88.8 to 139.7)	119.54 (95.0 to 150.5)	173.08 (138.5 to 216.4)
B/Yamagata Day 1 HI GMT	16.95 (14.3 to 20.1)	16.02 (13.5 to 19.0)	14.59 (12.3 to 17.3)	15.99 (13.5 to 18.9)
B/Yamagata Day 29 HI GMT	69.35 (58.7 to 81.9)	50.99 (43.3 to 60.1)	37.51 (31.7 to 44.4)	60.25 (51.2 to 70.8)
B/Victoria Day 1 HI GMT	21.86 (18.5 to 25.8)	22.02 (18.7 to 25.9)	20.42 (17.3 to 24.2)	24.82 (21.1 to 29.2)
B/Victoria Day 29 HI GMT	94.82 (80.4 to 111.8)	69.49 (59.1 to 81.7)	52.35 (44.3 to 61.8)	75.50 (64.3 to 88.6)
A/H3N2 Day 1 MN GMT	71.44 (61.7 to 82.7)	59.37 (51.4 to 68.6)	60.20 (52.0 to 69.7)	64.93 (56.3 to 74.9)
A/H3N2 Day 29 MN GMT	138.88 (120.7 to 159.8)	117.28 (102.2 to 134.6)	106.22 (92.3 to 122.3)	174.78 (152.6 to 200.2)

Population analysed: Per Protocol Set (PPS): All subjects in the Full Analysis Set (FAS) Immunogenicity who: * Correctly received the vaccine (ie, received the vaccine to which the subject was randomized). * Had no clinical study report (CSR)-reportable protocol deviation (PD) leading to exclusion (ie, impacting the results) as defined prior to unblinding. * Had immunogenicity assessments within the window of +/- 7 days around the Day 29 visit, and Day 1 sample taken within 3 days before vaccination.

Primary outcome: Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses

Time frame: 28 days post-vaccination. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Licensed IIV4c Group n = 114	Licensed aIIV4 Group n = 109	Licensed RIV4 Group n = 116
A/H1N1 HI GMR (aIIV4c/comparator group)	1.31 (0.96 to 1.79)	1.22 (0.89 to 1.68)	0.84 (0.62 to 1.15)
B/Yamagata HI GMR (aIIV4c/comparator group)	1.36 (1.08 to 1.71)	1.85 (1.47 to 2.33)	1.15 (0.92 to 1.44)
B/Victoria HI GMR (aIIV4c/comparator group)	1.36 (1.09 to 1.71)	1.81 (1.44 to 2.27)	1.26 (1.00 to 1.57)
A/H3N2 MN GMR (aIIV4c/comparator group)	1.18 (0.98 to 1.43)	1.31 (1.08 to 1.59)	0.79 (0.66 to 0.96)

Primary outcome: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses

Time frame: 28 days post-vaccination. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Investigational aIIV4c Group n = 110	Licensed IIV4c Group n = 114	Licensed aIIV4 Group n = 109	Licensed RIV4 Group n = 116
A/H1N1 HI seroconversion Day 29	61.8 (52.1 to 70.9)	54.4 (44.8 to 63.7)	50.5 (40.7 to 60.2)	61.2 (51.7 to 70.1)
B/Yamagata HI seroconversion Day 29	42.7 (33.3 to 52.5)	31.6 (23.2 to 40.9)	19.3 (12.3 to 27.9)	37.9 (29.1 to 47.4)
B/Victoria HI seroconversion Day 29	46.4 (36.8 to 56.1)	33.3 (24.8 to 42.8)	26.6 (18.6 to 35.9)	40.5 (31.5 to 50.0)
A/H3N2 MN seroconversion Day 29	21.8 (14.5 to 30.7)	20.2 (13.2 to 28.7)	9.2 (4.5 to 16.2)	32.8 (24.3 to 42.1)

Primary outcome: Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses

Time frame: 28 days post-vaccination. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Investigational aIIV4c Group n = 110	Licensed IIV4c Group n = 114	Licensed aIIV4 Group n = 109	Licensed RIV4 Group n = 116
A/H1N1 Day 1	44.5 (35.1 to 54.3)	36.8 (28.0 to 46.4)	41.3 (31.9 to 51.1)	38.8 (29.9 to 48.3)
A/H1N1 Day 29	85.5 (77.5 to 91.5)	81.6 (73.2 to 88.2)	82.6 (74.1 to 89.2)	84.5 (76.6 to 90.5)
B/Yamagata day 1	27.3 (19.2 to 36.6)	23.7 (16.2 to 32.6)	20.2 (13.1 to 28.9)	28.4 (20.5 to 37.6)
B/Yamagata Day 29	81.8 (73.3 to 88.5)	64.0 (54.5 to 72.8)	52.3 (42.5 to 61.9)	65.5 (56.1 to 74.1)
B/Victoria Day 1	32.7 (24.1 to 42.3)	32.5 (24.0 to 41.9)	30.3 (21.8 to 39.8)	38.8 (29.9 to 48.3)
B/Victoria Day 29	90.0 (82.8 to 94.9)	72.8 (63.7 to 80.7)	69.7 (60.9 to 78.2)	79.3 (70.8 to 86.3)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational aIIV4c Group	2 of 116 (1.7%)	86 of 116 (74.1%)	1 of 116
Licensed IIV4c Group	1 of 119 (0.8%)	77 of 119 (64.7%)	0 of 119
Licensed aIIV4 Group	4 of 116 (3.4%)	84 of 116 (72.4%)	0 of 116
Licensed RIV4 Group	6 of 120 (5%)	83 of 120 (69.2%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39946829Essink BJ, Vermeulen W, Andrade C, de Rooij R, Isakov L, Casula D, Albano FR. A randomised phase 2 immunogenicity and safety study of a MF59-adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine (aQIVc) in adults aged 50 years and older. Vaccine. 2025 Apr 2;51:126791. doi: 10.1016/j.vaccine.2025.126791. Epub 2025 Feb 12.
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 Common Technical Documents (CTD) modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigational aIIV4c, IIV4c and aIIV4 in people with Influenza and Human, run by Seqirus at 21 sites in United States.

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 4 inclusion and 17 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 17 Apr 2024). 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) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses (time frame: 28 days post-vaccination). 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 NCT04576702, 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 17 Apr 2024.