A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Quadrivalent Influenza Vaccine Compared to a Non-adjuvanted Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age
Influenza, Human
About this trial
This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, Vaccine, MF59 adjuvant, aQIV, A/H1N1, A/H3N2, B/Yamagata, B/Victoria
Eligibility Criteria
Inclusion Criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. Adults of ≥65 years of age on the day of vaccination. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who have the ability to comply with study procedures including follow-up. Exclusion Criteria: In order to participate in this study, all subjects must not meet any of the exclusion criteria described below: Bedridden subjects (i.e. confined to bed by sickness or old age). Subjects that are incapacitated and because of that in need of a Legally Authorized Representative. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis. Clinical conditions representing a contra-indication 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 ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted; 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 any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire 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. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel. Participation in the current study for more than one season.
Sites / Locations
- 26803 - JSC Evex Hospitals
- 26801 - LTD Hospital Service
- 26802 - LTD Emergency Cardiology Center
- 26804 - JSC Eristavi National Center
- 79209 - Hacettepe University Faculty of Medicine
- 79202 - Ankara University Faculty of Medicine
- 79207 - Akdeniz University Faculty of Medicine
- 79212 - Dicle University Faculty of Medicine
- 79201 - Liv Hospital Vadistanbul
- 79205 - Goztepe Suleyman Yalcin City Hospital
- 79203 - Acibadem Atakent Hospital
- 79213 - Ege University Faculty of Medicine
- 79208 - Izmir Dr. Suat Seren Pulmonary Hospital
- 79210 - Dokuz Eylul University Faculty of Medicine
- 79204 - Kocaeli University Faculty of Medicine
- 79206 - Ondokuz Mayis University Faculty of Medicine
- 79211 - Karadeniz Technical University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Other
aQIV
Comparator QIV
MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains