Status and phase
Conditions
Treatments
About
The purpose of the study is to evaluate the safety and immunogenicity of GSK Biologicals' influenza vaccine GSK2340272A.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
A male or female aged 18 to 60 years at the time of the first vaccination.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol
Written informed consent obtained from the subject.
Satisfactory baseline medical assessment by history and physical examination. Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrollment.
Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion criteria
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Presence of an axillary temperature ≥ 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
Diagnosed with cancer, or treatment for cancer, within the past 3 years.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
An acute evolving neurological disorder or history of Guillain-Barré syndrome.
Administration of any vaccines within 30 days before vaccination.
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Primary purpose
Allocation
Interventional model
Masking
130 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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