A phase II, randomised, open study to evaluate the immunogenicity and safety of a single or double-dose of the pandemic influenza candidate vaccine split virus formulation adjuvanted with AS03 given following a two-administration schedule 21 days apart in adults over 60 years of age. - H5N1-010 e H5N1-021

Conditions: Immunization against influenza disease during pandemic in subjects over 60 years of age.
MedDRA version: 6.1Level: PTClassification code 10022000

Registration Number: EUCTR2006-004041-42-IT

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 480

Inclusion Criteria

Subjects who the investigator believes that they can and will comply with the requirements of the protocol e.g., completion of the diary cards, return for follow-up visits should be enrolled in the study. A male or female aged 61 years or above at the time of the first vaccination. Written informed consent obtained from the subject. Healthy subjects or subjects with well controlled underlying disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Administration of licensed vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine. Chronic administration defined as more than 14 days of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine. For corticosteroids, this will mean prednisone, or equivalent, 8805; 0.5 mg/kg/Day. Inhaled and topical steroids are allowed . Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination no laboratory testing required . History of chronic alcohol consumption and/or drug abuse. History of hypersensitivity to vaccines. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including egg and thiomersal allergy . Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever defined as axillary temperature 8805;37.5 C . Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included, as well as subjects with well controlled underlying diseases . Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study. Use of any investigational or non-registered product drug or vaccine other than the study vaccine s within 30 days prior to the first vaccination, or planned use during the study period. Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.