InfluenzaPhase 2NCT04782323

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

A Phase 2 study testing aQII-1, aQII-3 Investigational and aQII-6 Investigational in people with Influenza, run by Seqirus at 30 sites in 4 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

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: aQII-1, aQII-3 Investigational and aQII-6 Investigational
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 839 participants
Where: 30 sitesin 4 countries
Study dates: 13 Apr 2021to 3 Mar 2022
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

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Individuals ≥50 years of age 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 informed consent and who do not plan to do so for at least 2 months after the study vaccination.
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
History of any medical condition considered an adverse event of special interest (AESI).
Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.

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Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.
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 consent.
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
Receipt of 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

30 sites in 4 countries.

Country

City, postcode or hospital

30 sites in 4 countries

Australia11 sites

03605 - PCRN_Paratus Clinical Research (Central Coast)
Blacktown, New South Wales, 2148
3610- Emeritis Research
Botany, New South Wales, 2019
3609 - Northern Beaches Clinical Research [NSW]
Brookvale, New South Wales, 2100
03607 - PCRN_Paratus Clinical Research
Bruce, Australian Capital Territory, 2617
03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW]
Kanwal, New South Wales, 2259
03608 - Australian Clinical Research Network - ACRN [NSW]
Maroubra, New South Wales, 2035
3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity
Melbourne, Victoria, 3000
03604 - University of the Sunshine Coast Clinical Trials Centre
Morayfield, Queensland, 4506
03603 - University of the Sunshine Coast
Sippy Downs, Queensland, 4556
03601 - AusTrials Taringa [QLD]
Taringa, Queensland, 4068
03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD]
Tarragindi, Queensland, 4121

Other trials in Australia

South Africa8 sites

71005 South Africa Haylene71005 - Tiervlei Trial Centre -- Karl Bremer Hospital
Bellville, 7531
71002 - JOSHA Research
Bloemfontein, 9301
71011 - Farmovs
Bloemfontein, 9301
71004 - Tread Research -- Tygerberg Hospital
Cape Town, 7505
71006 - Mzansi Ethical Research Centre (MERC)
Mpumalanga, 1050
71003- Newtown Clinical Research
Newtown, Johannesburg, 2113
71009 - Be Part Yoluntu Centre
Paarl, 7626
71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital
Soweto, 2013

Other trials in South Africa

New Zealand6 sites

55406 - Optimal Clinical Trials
Auckland, 1010
55402- PCRN_Southern Clinical Trials Waitemata
Birkenhead, Auckland, 0626
55404- PCRN_Southern Clinical Trials Christchurch
Christchurch, 8013
55403-PCRN_Lakeland Clinical Trials Waikato
Hamilton, 3200
55401- PCRN_Southern Clinical Trials Totara
New Lynn, Auckland, 0600
55405 - PCRN_Lakeland Clinical Trials
Rotorua, 3010

Other trials in New Zealand

Philippines5 sites

60801 - De La Salle Medical and Health Sciences Institute
Dasmariñas, Cavite, 4114
60805 - Manila Doctors' Hospital
Ermita, Manila, 1000
60802 - West Visayas University Medical Center
Jaro, Iloilo City, 5000
60803 - Philippine General Hospital
Manila, 1000
60804 - Quirino Memorial Medical Center
Quezon City, Quezon, 1109

Other trials in Philippines

About this study

Official title: A Phase 2, Randomized, Observer-blind, Antigen and Adjuvant Dose Ranging Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59 Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age

This Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults.

Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.

Conditions: Influenza
Being tested: aQII-1, aQII-3 Investigational, aQII-6 Investigational, aQII-7 Investigational, aQII-9 Investigational
Medical subject headings: Influenza, Human

What participants receive

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

aQII-1Drug
Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted 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.
aQII-3 InvestigationalDrug
Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted 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.
aQII-6 InvestigationalDrug
Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted 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.
aQII-7 InvestigationalOther
Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted 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.
aQII-9 InvestigationalDrug
Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted 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.
aQII-10 InvestigationalDrug
Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted 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.
aQII-11 InvestigationalDrug
Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted 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.
Licensed QII Active ComparatorDrug
Biological/Vaccine: Licensed QII Licensed 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.

Study groups in NCT04782323
Study group	Role	What they receive
Group A aQII-1 Investigational	Experimental	Not described Receives: Drug: aQII-1
Group B aQII-3 Investigational	Experimental	Not described Receives: Drug: aQII-3 Investigational
Group C aQII-6 Investigational	Experimental	Not described Receives: Drug: aQII-6 Investigational
Group D aQII-7 Investigational	Experimental	Not described Receives: Other: aQII-7 Investigational
Group E aQII-9 Investigational	Experimental	Not described Receives: Drug: aQII-9 Investigational
Group F aQII-10 Investigational	Experimental	Not described Receives: Drug: aQII-10 Investigational
Group G aQII-11 Investigational	Experimental	Not described Receives: Drug: aQII-11 Investigational
Group H Licensed QII Active Comparator	Active comparator	Not described Receives: Drug: Licensed QII Active Comparator

What is being measured

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

Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
Measured: [28 days post-vaccination]
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
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 A/H3N2 Strain Using MN Assay
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)
Measured: 28 days post-vaccination
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
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)
Measured: 28 days post-vaccination

Secondary outcomes (9)

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) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
Measured: 28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
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
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) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
Measured: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
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)
Measured: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
Measured: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
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.

13 Apr 20213 Mar 2022

First posted4 Mar 2021
Study start13 Apr 2021
Primary completion22 Sep 2021
Study completion3 Mar 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 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 839 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04782323
Sponsor's protocol ID: V201_01
Status last verified: Oct 2024
First submitted: 1 Mar 2021
Last updated: 10 Oct 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 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Observer-blind, Antigen and Adjuvant Dose Ranging Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59 Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age
ClinicalTrials.gov ID: NCT04782323
Acronym / sponsor ID: V201_01
Conditions: Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 839 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: 13 Apr 2021 (actual)
Primary completion: 22 Sep 2021 (actual)
Study completion: 3 Mar 2022 (actual)
First posted: 4 Mar 2021 (actual)
Results: Posted 10 Oct 2024

Clinical summary

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

Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 8

Arm	Type	Receives
Group A aQII-1 Investigational	Experimental	Drug: aQII-1
Group B aQII-3 Investigational	Experimental	Drug: aQII-3 Investigational
Group C aQII-6 Investigational	Experimental	Drug: aQII-6 Investigational
Group D aQII-7 Investigational	Experimental	Other: aQII-7 Investigational
Group E aQII-9 Investigational	Experimental	Drug: aQII-9 Investigational
Group F aQII-10 Investigational	Experimental	Drug: aQII-10 Investigational
Group G aQII-11 Investigational	Experimental	Drug: aQII-11 Investigational
Group H Licensed QII Active Comparator	Active comparator	Drug: Licensed QII Active Comparator

Who may qualify

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

Key inclusion criteria (5 listed)

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Individuals ≥50 years of age 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 (18 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 informed consent and who do not plan to do so for at least 2 months after the study vaccination.
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
History of any medical condition considered an adverse event of special interest (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
aQII-1Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted 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.	Drug	Group A aQII-1 Investigational
aQII-3 InvestigationalBiological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted 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.	Drug	Group B aQII-3 Investigational
aQII-6 InvestigationalBiological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted 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.	Drug	Group C aQII-6 Investigational
aQII-7 InvestigationalBiological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted 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.	Other	Group D aQII-7 Investigational
aQII-9 InvestigationalBiological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted 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.	Drug	Group E aQII-9 Investigational
aQII-10 InvestigationalBiological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted 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.	Drug	Group F aQII-10 Investigational
aQII-11 InvestigationalBiological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted 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.	Drug	Group G aQII-11 Investigational
Licensed QII Active ComparatorBiological/Vaccine: Licensed QII Licensed 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.	Drug	Group H Licensed QII Active Comparator

Primary outcome

Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
Time frame: [28 days post-vaccination]
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
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 A/H3N2 Strain Using MN Assay
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)
Time frame: 28 days post-vaccination
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
Time frame: 7 days post-vaccination
Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
Time frame: 28 days post-vaccination
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
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)
Time frame: 28 days post-vaccination

9 secondary outcomes

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) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
Time frame: 28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
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
Time frame: 28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
Time frame: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
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)
Time frame: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
Time frame: 180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
Time frame: 180 days post-vaccination

Results and safety

Results posted to the registry on 10 Oct 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
Group H Licensed QII Active Comparator	98	96
Group A aQII-1 Investigational	107	106
Group E aQII-9 Investigational	107	105
Group C aQII-6 Investigational	103	103
Group F aQII-10 Investigational	106	105
Group B aQII-3 Investigational	108	105
Group D aQII-7 Investigational	101	99
Group G aQII-11 Investigational	109	106

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

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

Measure	Group H Licensed QII Active Comparator n = 95	Group A aQII-1 Investigational n = 105	Group E aQII-9 Investigational n = 106	Group C aQII-6 Investigational n = 99	Group F aQII-10 Investigational n = 102	Group B aQII-3 Investigational n = 104	Group D aQII-7 Investigational n = 95	Group G aQII-11 Investigational n = 104
A/H1N1 Day 1 HI GMT	42.31 (34.3 to 52.2)	40.39 (33.1 to 49.3)	48.29 (39.6 to 58.9)	49.31 (40.1 to 60.6)	46.19 (37.7 to 56.6)	47.50 (38.9 to 58.1)	46.92 (38.0 to 57.9)	37.24 (30.5 to 45.5)
A/H1N1 Day 29 HI GMT	228.11 (181.2 to 287.1)	175.95 (141.3 to 219.1)	200.22 (161.1 to 248.8)	225.66 (180.0 to 282.8)	223.37 (179.0 to 278.8)	243.16 (195.2 to 302.9)	270.55 (215.0 to 340.5)	220.29 (176.8 to 274.5)
B/Yamagata Day 1 HI GMT	15.02 (12.5 to 18.0)	16.7 (14.1 to 19.8)	20.83 (17.6 to 24.7)	18.35 (15.4 to 21.9)	15.51 (13.0 to 18.5)	16.41 (13.8 to 19.5)	17.13 (14.3 to 20.5)	16.00 (13.5 to 19.0)
B/Yamagata Day 29 HI GMT	47.73 (40.0 to 56.9)	47.46 (40.2 to 56.1)	59.74 (50.6 to 70.5)	62.34 (52.5 to 74.1)	61.36 (51.8 to 72.7)	63.21 (53.5 to 74.7)	68.14 (57.2 to 81.2)	69.13 (58.5 to 81.7)
B/Victoria Day 1 HI GMT	58.85 (48.0 to 72.1)	74.31 (61.2 to 90.1)	65.27 (53.9 to 79.1)	68.00 (55.7 to 83.0)	62.26 (51.2 to 75.7)	63.72 (52.5 to 77.4)	79.15 (64.6 to 97.0)	64.13 (52.8 to 77.8)
B/Victoria Day 29 HI GMT	145.12 (124.5 to 169.1)	146.85 (126.9 to 169.9)	138.29 (119.7 to 159.8)	141.84 (122.1 to 164.8)	178.15 (153.7 to 206.4)	160.54 (138.7 to 185.8)	181.93 (156.1 to 212.0)	186.06 (160.8 to 215.3)
A/H3N2 Day 1 MN GMT	35.31 (29.2 to 42.7)	31.61 (26.4 to 37.8)	32.05 (26.8 to 38.3)	32.48 (27.0 to 39.1)	36.83 (30.7 to 44.2)	32.71 (27.3 to 39.2)	30.80 (25.5 to 37.2)	27.15 (22.7 to 32.5)
A/H3N2 Day 29 MN GMT	146.59 (124.0 to 173.3)	142.04 (121.2 to 166.5)	178.87 (152.8 to 209.4)	185.07 (157.1 to 218.0)	193.02 (164.3 to 226.8)	189.17 (161.3 to 221.9)	197.27 (166.9 to 233.1)	157.90 (134.6 to 185.3)

Population analysed: Per Protocol Set (PPS) Immunogenicity: All subjects in the FAS Immunogenicity who * Correctly received the vaccine (ie, received the vaccine to which the subject was randomized within the defined window). * Had no CSR-reportable PD leading to exclusion (ie, impacting the results) as defined prior to unblinding. * Had immunogenicity assessments within the window of -7/+21 days around the Day 29 visit, and Day 1 sample taken. * Were not excluded due to other reason defined prior to unblinding.

Primary outcome: Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay

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

Measure	Group A aQII-1 Investigational n = 105	Group E aQII-9 Investigational n = 106	Group C aQII-6 Investigational n = 99	Group F aQII-10 Investigational n = 102	Group B aQII-3 Investigational n = 104	Group D aQII-7 Investigational n = 95	Group G aQII-11 Investigational n = 104
A/H1N1 HI GMR (aQII/QII)	0.77 (0.56 to 1.06)	0.88 (0.64 to 1.20)	0.99 (0.72 to 1.36)	0.98 (0.71 to 1.35)	1.07 (0.78 to 1.46)	1.19 (0.86 to 1.64)	0.97 (0.70 to 1.33)
B/Yamagata HI GMR (aQII/QII)	0.99 (0.78 to 1.27)	1.25 (0.98 to 1.59)	1.31 (1.02 to 1.67)	1.29 (1.01 to 1.64)	1.32 (1.04 to 1.69)	1.43 (1.12 to 1.83)	1.45 (1.14 to 1.84)
B/Victoria HI GMR (aQII/QII)	1.01 (0.82 to 1.25)	0.95 (0.77 to 1.18)	0.98 (0.79 to 1.21)	1.23 (0.99 to 1.52)	1.11 (0.9 to 1.37)	1.25 (1.01 to 1.56)	1.28 (1.04 to 1.58)
A/H3N2 MN GMR (aQII/QII)	0.97 (0.77 to 1.22)	1.22 (0.97 to 1.53)	1.26 (1.00 to 1.59)	1.32 (1.04 to 1.66)	1.29 (1.03 to 1.62)	1.35 (1.06 to 1.70)	1.08 (0.86 to 1.36)

Population analysed: The analysis population is PPS Immunogenicity.

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

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

Measure	Group H Licensed QII Active Comparator n = 95	Group A aQII-1 Investigational n = 105	Group E aQII-9 Investigational n = 106	Group C aQII-6 Investigational n = 99	Group F aQII-10 Investigational n = 102	Group B aQII-3 Investigational n = 104	Group D aQII-7 Investigational n = 95	Group G aQII-11 Investigational n = 104
A/H1N1 HI seroconversion Day 29	55.8 (45.2 to 66.0)	53.3 (43.3 to 63.1)	51.9 (42.0 to 61.7)	54.5 (44.2 to 64.6)	57.8 (47.7 to 67.6)	58.7 (48.6 to 68.2)	60.0 (49.4 to 69.9)	57.7 (47.6 to 67.3)
B/Yamagata HI seroconversion Day 29	35.8 (26.2 to 46.3)	35.2 (26.2 to 45.2)	42.5 (32.9 to 52.4)	46.5 (36.4 to 56.8)	41.2 (31.5 to 51.4)	46.2 (36.3 to 56.2)	48.4 (38.0 to 58.9)	51.0 (41.0 to 60.9)
B/Victoria HI seroconversion Day 29	32.6 (23.4 to 43.0)	25.7 (17.7 to 35.2)	22.6 (15.1 to 31.8)	26.3 (17.9 to 36.1)	35.3 (26.1 to 45.4)	38.5 (29.1 to 48.5)	34.7 (25.3 to 45.2)	34.6 (25.6 to 44.6)
A/H3N2 MN seroconversion Day 29	53.7 (43.2 to 64.0)	54.3 (44.3 to 64.0)	67.0 (57.2 to 75.8)	62.6 (52.3 to 72.1)	59.8 (49.6 to 69.4)	62.5 (52.5 to 71.8)	71.6 (61.4 to 80.4)	65.4 (55.4 to 74.4)

Population analysed: The analysis population is PPS Immunogenicity.

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

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

Measure	Group H Licensed QII Active Comparator n = 95	Group A aQII-1 Investigational n = 105	Group E aQII-9 Investigational n = 106	Group C aQII-6 Investigational n = 99	Group F aQII-10 Investigational n = 102	Group B aQII-3 Investigational n = 104	Group D aQII-7 Investigational n = 95	Group G aQII-11 Investigational n = 104
A/H1N1 Day 1	66.3 (55.9 to 75.7)	60.0 (50.0 to 69.4)	67.9 (58.2 to 76.7)	71.7 (61.8 to 80.3)	68.6 (58.7 to 77.5)	66.3 (56.4 to 75.3)	66.3 (55.9 to 75.7)	51.0 (41.0 to 60.9)
A/H1N1 Day 29	95.8 (89.6 to 98.8)	94.3 (88.0 to 97.9)	96.2 (90.6 to 99.0)	93.9 (87.3 to 97.7)	92.2 (85.1 to 96.6)	95.2 (89.1 to 98.4)	98.9 (94.3 to 100.0)	90.4 (83.0 to 95.3)
B/Yamagata day 1	22.1 (14.2 to 31.8)	29.5 (21.0 to 39.2)	34.9 (25.9 to 44.8)	28.3 (19.7 to 38.2)	22.5 (14.9 to 31.9)	25.0 (17.0 to 34.4)	27.4 (18.7 to 37.5)	26.9 (18.7 to 36.5)
B/Yamagata day 29	74.7 (64.8 to 83.1)	68.6 (58.8 to 77.3)	78.3 (69.2 to 85.7)	84.8 (76.2 to 91.3)	77.5 (68.1 to 85.1)	75.0 (65.6 to 83.0)	80.0 (70.5 to 87.5)	79.8 (70.8 to 87.0)
B/Victoria Day 1	72.6 (62.5 to 81.3)	78.1 (69.0 to 85.6)	81.1 (72.4 to 88.1)	79.8 (70.5 to 87.2)	71.6 (61.8 to 80.1)	76.0 (66.6 to 83.8)	78.9 (69.4 to 86.6)	74.0 (64.5 to 82.1)
B/Victoria Day 29	94.7 (88.1 to 98.3)	92.4 (85.5 to 96.7)	95.3 (89.3 to 98.5)	94.9 (88.6 to 98.3)	97.1 (91.6 to 99.4)

9 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
Group H Licensed QII Active Comparator	8 of 97 (8.2%)	55 of 97 (56.7%)	1 of 97
Group A aQII-1 Investigational	1 of 107 (0.9%)	74 of 107 (69.2%)	0 of 107
Group E aQII-9 Investigational	1 of 108 (0.9%)	80 of 108 (74.1%)	0 of 108
Group C aQII-6 Investigational	3 of 103 (2.9%)	79 of 103 (76.7%)	0 of 103
Group F aQII-10 Investigational	5 of 106 (4.7%)	91 of 106 (85.8%)	1 of 106
Group B aQII-3 Investigational	3 of 107 (2.8%)	81 of 107 (75.7%)	1 of 107
Group D aQII-7 Investigational	2 of 101 (2%)	72 of 101 (71.3%)	1 of 101
Group G aQII-11 Investigational	2 of 109 (1.8%)	89 of 109 (81.7%)	0 of 109

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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.

Therapeutic Area Head study chair

Seqirus

30 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aQII-1, aQII-3 Investigational and aQII-6 Investigational in people with Influenza, run by Seqirus at 30 sites in 4 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 18 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Australia, South Africa, New Zealand, Philippines. 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 10 Oct 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) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay (time frame: [28 days post-vaccination]). The study lists 7 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 NCT04782323.

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 10 Oct 2024.