Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
NCT ID: NCT04782323
Last Updated: 2024-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
839 participants
INTERVENTIONAL
2021-04-13
2022-03-03
Brief Summary
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Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group A aQII-1 Investigational
aQII-1
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.
Group B aQII-3 Investigational
aQII-3 Investigational
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.
Group C aQII-6 Investigational
aQII-6 Investigational
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.
Group D aQII-7 Investigational
aQII-7 Investigational
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.
Group E aQII-9 Investigational
aQII-9 Investigational
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.
Group F aQII-10 Investigational
aQII-10 Investigational
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.
Group G aQII-11 Investigational
aQII-11 Investigational
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.
Group H Licensed QII Active Comparator
Licensed QII Active Comparator
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.
Interventions
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aQII-1
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 Investigational
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 Investigational
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 Investigational
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 Investigational
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 Investigational
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 Investigational
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 Comparator
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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Individuals who can comply with study procedures including follow-up .
4. 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.
Exclusion Criteria
2. Progressive, unstable or uncontrolled clinical conditions.
3. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
4. History of any medical condition considered an adverse event of special interest (AESI).
5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
6. Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.
7. Abnormal function of the immune system resulting from:
1. Clinical conditions.
2. 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.
3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
9. Receipt of an investigational or non-registered medicinal product within 30 days prior to vaccination.
10. 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.
11. Study personnel or immediate family or household member of study personnel.
12. 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.
13. Acute (severe) febrile illness.
14. 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.
50 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Therapeutic Area Head
Role: STUDY_CHAIR
Seqirus
Locations
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03607 - PCRN_Paratus Clinical Research
Bruce, Australian Capital Territory, Australia
03605 - PCRN_Paratus Clinical Research (Central Coast)
Blacktown, New South Wales, Australia
3610- Emeritis Research
Botany, New South Wales, Australia
3609 - Northern Beaches Clinical Research [NSW]
Brookvale, New South Wales, Australia
03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW]
Kanwal, New South Wales, Australia
03608 - Australian Clinical Research Network - ACRN [NSW]
Maroubra, New South Wales, Australia
03604 - University of the Sunshine Coast Clinical Trials Centre
Morayfield, Queensland, Australia
03603 - University of the Sunshine Coast
Sippy Downs, Queensland, Australia
03601 - AusTrials Taringa [QLD]
Taringa, Queensland, Australia
03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD]
Tarragindi, Queensland, Australia
3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity
Melbourne, Victoria, Australia
55402- PCRN_Southern Clinical Trials Waitemata
Birkenhead, Auckland, New Zealand
55401- PCRN_Southern Clinical Trials Totara
New Lynn, Auckland, New Zealand
55406 - Optimal Clinical Trials
Auckland, , New Zealand
55404- PCRN_Southern Clinical Trials Christchurch
Christchurch, , New Zealand
55403-PCRN_Lakeland Clinical Trials Waikato
Hamilton, , New Zealand
55405 - PCRN_Lakeland Clinical Trials
Rotorua, , New Zealand
60801 - De La Salle Medical and Health Sciences Institute
Dasmariñas, Cavite, Philippines
60802 - West Visayas University Medical Center
Jaro, Iloilo City, Philippines
60805 - Manila Doctors' Hospital
Ermita, Manila, Philippines
60804 - Quirino Memorial Medical Center
Quezon City, Quezon, Philippines
60803 - Philippine General Hospital
Manila, , Philippines
71003- Newtown Clinical Research
Newtown, Johannesburg, South Africa
71005 South Africa Haylene71005 - Tiervlei Trial Centre -- Karl Bremer Hospital
Bellville, , South Africa
71002 - JOSHA Research
Bloemfontein, , South Africa
71011 - Farmovs
Bloemfontein, , South Africa
71004 - Tread Research -- Tygerberg Hospital
Cape Town, , South Africa
71006 - Mzansi Ethical Research Centre (MERC)
Mpumalanga, , South Africa
71009 - Be Part Yoluntu Centre
Paarl, , South Africa
71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital
Soweto, , South Africa
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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V201_01
Identifier Type: -
Identifier Source: org_study_id
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