- 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.
Influenza, Human
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
NCT06087640 | Phase 3 | Interventional
This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a non-adjuvanted quadrivalent influenza vaccine (QIV) in adults ≥65 years of age. The aim of the study is to evaluate aQIV compared with QIV in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.
Trial Information
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Universitair Ziekenhuis Gent
Gent,Belgium,41380
ResearchLink
Linkebeek,Belgium
MHAT Dr. Tota Venkova
Gabrovo,Bulgaria
Medical Center Zdrave
Kozloduy,Bulgaria
Medical Centre Leo Clinic EOOD
Lovech,Bulgaria
Medical Center Hera EOOD
Montana,Bulgaria
MultiProfile Hospital For Active Treatment Dr. Stamen Iliev AD
Montana,Bulgaria
MC Med Consult Pleven
Pleven,Bulgaria
Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov
Plovdiv,Bulgaria
Multiprofile Hospital for Active Treatment Sv. Panteleymon Plovdiv
Plovdiv,Bulgaria
Medical Center Prolet EOOD
Ruse,Bulgaria
Specialized Hospital For Active Treatment Of PneumoPhthisiatric Diseases Dr. Dimitar GramatikovRuse EOOD
Ruse,Bulgaria
Diagnostic Consultative Center Sevlievo EOOD
Sevlievo,Bulgaria
DCC Sliven
Sliven,Bulgaria
DCC Sofia
Sofia,Bulgaria
Medical Center Hera Pulmonology Office
Sofia,Bulgaria
Medical Center Intermedica
Sofia,Bulgaria
Medical Center Excelsior OOD
Sofia,Bulgaria
AIPPMP Dr Zhaneta Demireva
Stamboliyski,Bulgaria
CCR Brno s.r.o.
Brno,Czechia
MUDr. Jakub Strincl, s.r.o.
Liberec,Czechia
CCR Ostrava, s.r.o.
Ostrava,Czechia
Zdravi fit, s.r.o.
Protivín,Czechia
Prof. MUDr. Jiri Beran, s.r.o.
České Budějovice,Czechia
ADMED, s.r.o.
České Budějovice,Czechia
Oulu Vaccine Research Clinic
Oulu,Finland
Tampere Vaccine Research Clinic
Tampere,Finland
Turku Vaccine Research Clinic
Turku,Finland
JSC Evex Hospitals
Batumi,Georgia
PO A. Manzoni di Lecco, ASST Lecco
Lecco,Italy
UAB InMedica
Kaunas,Lithuania
JSC Sauls eimos Medicinos Centras
Kaunas,Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas,Lithuania
Emotional Brain BV
Almere,Netherlands
RCMed Oddzial Sochaczew
Sochaczew,Poland
KOMED Centra Kliniczne Staszow
Staszów,Poland
ETG Warszawa
Warsaw,Poland
FutureMeds Targowek
Warsaw,Poland
FutureMeds Sp. z o.o.
Wrocław,Poland
FutureMeds Lodz
Łódź,Poland
Sana Monitoring
Bucuresti,Romania
Ames Research Center
Călăraşi,Romania
Clintrial Medical Center
Reșca,Romania
NovaClin Medical Research Center
Timişoara,Romania
EAP Vic CAP El Remei
Barcelona,Spain
Hospital Universitario Son Espases
Palma de Mallorca,Spain
Hospital Povisa
Vigo,Spain
Kocaeli University Faculty of Medicine
Kocaeli,Turkey
Study Eligibility 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.
Additional Studies
Additional studies can be found at ClinicalTrials.gov