safety & immunogenicity of an alternative immunization schedule of gsk bio's pandemic influenza vaccine (gsk1119711a)

Conditions: Influenza; Influenza Vaccines

Summary: the aim of the study is to assess the safety \& immunogenicity of a pandemic influenza vaccine administered at 2 different time points. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 18 and 60 years of age at the time of the first vaccination. * written informed consent obtained from the subject. * 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; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. exclusion criteria: * administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. * history of vaccination with investigational influenza pandemic vaccine. * history of administration of an experimental/licensed vaccine * planned administration of a vaccine not foreseen by the study protocol during the following periods: from day 0 up to day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to month 6 and month 12; from month 6 up to month 6 + 30 days; from month 12 up to month 12 + 30 days. * 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 candidate vaccines * 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. * history of chronic alcohol consumption and/or drug abuse. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. * 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 candidate 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. * any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Keywords: pandemic flu pandemic influenza vaccine (gsk1119711a)