safety, reactogenicity and immunogenicity of glaxosmithkline (gsk) biologicals' non-typeable haemophilus influenzae (nthi) vaccine

Conditions: Respiratory Disorders

Summary: the purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of gsk biologicals' nthi candidate vaccine in adults, administered for the first time in humans.


Eligibility criteria:
inclusion criteria: * subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * written informed consent obtained from the subject. * a male or female between, and including, 18 and 40 years of age at the time of the first vaccination. * healthy subjects as established by medical history, physical examination and laboratory assessment before entering into the study. * 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: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. * planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first vaccine dose and ending 30 days after the last dose of vaccines. * previous vaccination with a vaccine containing nthi antigens. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or equivalent. topical steroids are allowed. * administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccines or planned administration during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * laboratory evidence of clinically significant haematological (complete blood cell count \[red blood cells (rbc), white blood cells (wbc)\], wbc differential count, platelets count and haemoglobin level) and biochemical (alanine aminotransferase \[alt\], aspartate aminotransferase \[ast\], creatinine and lactate dehydrogenase \[ldh\]) abnormalities as per the opinion of the investigator based on the local laboratory normative data. * acute disease and/or fever at the time of enrolment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * history of or current condition preventing intramuscular injection as bleeding or coagulation disorder. * malignancies within previous 5 years (excluding non-melanic skin cancer) and lymphoproliferative disorders. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions. * history of chronic alcohol consumption and/or drug abuse. * any other condition that the investigator judges may interfere with study findings.

Keywords: healthy adults safety reactogenicity immunogenicity non-typeable h. influenzae (nthi)