- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04782323
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
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 to determine the appropriate age population for this vaccine. 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Canberra
-
Bruce, Canberra, Australia, 2617
- 03607 - PCRN_Paratus Clinical Research
-
-
New South Wales
-
Blacktown, New South Wales, Australia, 2148
- 03605 - PCRN_Paratus Clinical Research (Central Coast)
-
Botany, New South Wales, Australia, 2019
- 3610- Emeritis Research
-
Brookvale, New South Wales, Australia, 2100
- 3609 - Northern Beaches Clinical Research [NSW]
-
Kanwal, New South Wales, Australia, 2259
- 03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW]
-
Maroubra, New South Wales, Australia, 2035
- 03608 - Australian Clinical Research Network - ACRN [NSW]
-
-
Queensland
-
Morayfield, Queensland, Australia, 4506
- 03604 - University of the Sunshine Coast Clinical Trials Centre
-
Sippy Downs, Queensland, Australia, 4556
- 03603 - University of the Sunshine Coast
-
Taringa, Queensland, Australia, 4068
- 03601 - AusTrials Taringa [QLD]
-
Tarragindi, Queensland, Australia, 4121
- 03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD]
-
-
Victoria
-
Melbourne, Victoria, Australia, 3000
- 3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity
-
-
-
-
-
Auckland, New Zealand, 1010
- 55406 - Optimal Clinical Trials
-
Christchurch, New Zealand, 8013
- 55404- PCRN_Southern Clinical Trials Christchurch
-
Hamilton, New Zealand, 3200
- 55403-PCRN_Lakeland Clinical Trials Waikato
-
Rotorua, New Zealand, 3010
- 55405 - PCRN_Lakeland Clinical Trials
-
-
Auckland
-
Birkenhead, Auckland, New Zealand, 0626
- 55402- PCRN_Southern Clinical Trials Waitemata
-
New Lynn, Auckland, New Zealand, 0600
- 55401- PCRN_Southern Clinical Trials Totara
-
-
-
-
-
Manila, Philippines, 1000
- 60803 - Philippine General Hospital
-
-
Cavite
-
Dasmariñas, Cavite, Philippines, 4114
- 60801 - De La Salle Medical and Health Sciences Institute
-
-
Iloilo City
-
Jaro, Iloilo City, Philippines, 5000
- 60802 - West Visayas University Medical Center
-
-
Manila
-
Ermita, Manila, Philippines, 1000
- 60805 - Manila Doctors' Hospital
-
-
Quezon
-
Quezon City, Quezon, Philippines, 1109
- 60804 - Quirino Memorial Medical Center
-
-
-
-
-
Bellville, South Africa, 7531
- 71005 South Africa Haylene71005 - Tiervlei Trial Centre -- Karl Bremer Hospital
-
Bloemfontein, South Africa, 9301
- 71002 - JOSHA Research
-
Bloemfontein, South Africa, 9301
- 71011 - Farmovs
-
Cape Town, South Africa, 7505
- 71004 - Tread Research -- Tygerberg Hospital
-
Mpumalanga, South Africa, 1050
- 71006 - Mzansi Ethical Research Centre (MERC)
-
Paarl, South Africa, 7626
- 71009 - Be Part Yoluntu Centre
-
Soweto, South Africa, 2013
- 71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital
-
-
Johannesburg
-
Newtown, Johannesburg, South Africa, 2113
- 71003- Newtown Clinical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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) (see Appendix 2 - List of Adverse Events 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.
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.
- 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 (see Section 4.3, Criteria for Delay of Vaccination).
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A aQII-1 Investigational
|
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.
|
EXPERIMENTAL: Group B 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.
|
EXPERIMENTAL: Group C 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.
|
EXPERIMENTAL: Group D 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.
|
EXPERIMENTAL: Group E 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.
|
EXPERIMENTAL: Group F 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.
|
EXPERIMENTAL: Group G 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.
|
ACTIVE_COMPARATOR: Group H QII Active Comparator
|
Biological/Vaccine: Investigational QII 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary Outcome Measure: 1. Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains
Time Frame: [28 days post-vaccination]
|
[28 days post-vaccination]
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V201_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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])
IPD Sharing Time Frame
Time Frame:
SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Avian Influenza | H1N1 InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...University of Oxford; Wellcome Trust; World Health OrganizationCompletedInfluenza | Avian Influenza | Severe InfluenzaSingapore, Thailand, Vietnam
-
NPO PetrovaxCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Acute Respiratory Infection | Influenza Type B | Flu | Influenza A H3N2 | Influenza A H1N1 | Flu, Human | Influenza EpidemicRussian Federation
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
Clinical Trials on aQII-1
-
Orasis Pharmaceuticals Ltd.Completed
-
University of ThessalyCompleted
-
University of Sao Paulo General HospitalCompleted
-
Chulalongkorn UniversityCompletedAllergic RhinitisThailand
-
University of Sao Paulo General HospitalCompletedOveractive Bladder SyndromeBrazil
-
Montreal Heart InstituteInstitut de Recherches Cliniques de Montreal; Royal Victoria Hospital, Canada; Queen Elizabeth II Health Sciences Centre and other collaboratorsCompletedHypertriglyceridemiaCanada
-
Yonsei UniversityCompletedObese Patients, One Lung VentilationKorea, Republic of
-
The University of Texas Health Science Center,...National Heart, Lung, and Blood Institute (NHLBI); United States Department... and other collaboratorsCompleted
-
Queen Margaret UniversityNHS LothianTerminated
-
Janssen Research & Development, LLCCompletedRelapsed or Refractory Hodgkin LymphomaFrance, Germany