Influenza

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

NCT04782323 | PHASE 2 | INTERVENTIONAL

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.

30 Sites

839 Participants

Recruiting

50 Years to 64 Years

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Find closest sites:

SUBMIT

PCRNParatus Clinical Research

Bruce,Canberra,Australia,2617

PCRNParatus Clinical Research (Central Coast)

Blacktown,New South Wales,Australia,2148

Emeritis Research

Botany,New South Wales,Australia,2019

Northern Beaches Clinical Research NSW

Brookvale,New South Wales,Australia,2100

PCRNParatus Clinical Research,(Western Sydney) NSW

Kanwal,New South Wales,Australia,2259

Australian Clinical Research Network ACRN NSW

Maroubra,New South Wales,Australia,2035

University of the Sunshine Coast Clinical Trials Centre

Morayfield,Queensland,Australia,4506

University of the Sunshine Coast

Sippy Downs,Queensland,Australia,4556

AusTrials Taringa QLD

Taringa,Queensland,Australia,4068

AusTrials Tarragindi (Aus Trial Wellers Hill)QLD

Tarragindi,Queensland,Australia,4121

The University of Melbourne Peter Doherty Institute for Infection and Immunity

Melbourne,Victoria,Australia,3000

PCRNSouthern Clinical Trials Waitemata

Birkenhead,Auckland,New Zealand,0626

PCRNSouthern Clinical Trials Totara

New Lynn,Auckland,New Zealand,0600

Optimal Clinical Trials

Auckland,New Zealand,1010

PCRNSouthern Clinical Trials Christchurch

Christchurch,New Zealand,8013

PCRNLakeland Clinical Trials Waikato

Hamilton,New Zealand,3200

PCRNLakeland Clinical Trials

Rotorua,New Zealand,3010

De La Salle Medical and Health Sciences Institute

Dasmariñas,Cavite,Philippines,4114

West Visayas University Medical Center

Jaro,Iloilo City,Philippines,5000

Manila Doctors' Hospital

Ermita,Manila,Philippines,1000

Quirino Memorial Medical Center

Quezon City,Quezon,Philippines,1109

Philippine General Hospital

Manila,Philippines,1000

Newtown Clinical Research

Newtown,Johannesburg,South Africa,2113

South Africa Haylene Tiervlei Trial Centre Karl Bremer Hospital

Bellville,South Africa,7531

JOSHA Research

Bloemfontein,South Africa,9301

Farmovs

Bloemfontein,South Africa,9301

Tread Research Tygerberg Hospital

Cape Town,South Africa,7505

Mzansi Ethical Research Centre (MERC)

Mpumalanga,South Africa,1050

Be Part Yoluntu Centre

Paarl,South Africa,7626

Wits Clinical Researc Chris Hani Baragwanath Academic Hospital

Soweto,South Africa,2013

Study Eligibility Criteria

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Individuals ≥50 years of age on the day of informed consent.
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

In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
1. 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.
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) (see Appendix 2 - List of Adverse Events of Special Interest).
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 consent5.
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 (see Section 4.3, Criteria for Delay of Vaccination).
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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov