Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged Between 18 and 60 Years
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring prophylaxis of pandemic influenza
Eligibility Criteria
Inclusion criteria: A male or female between, and including, 18 and 60 years of age at the time of the first vaccination. Healthy subjects as established by medical history and clinical examination before entering into the study. If the subject is female, she must be of non-childbearing potential. Exclusion criteria: Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one. Administration of an influenza vaccine other than the study vaccines during the entire study period. 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. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of hypersensitivity to vaccines. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 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. Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study. lactating women 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.
Sites / Locations
- GSK Investigational Site