study to evaluate safety, reactogenicity and immunogenicity of the pneumococcal protein phtd vaccine in healthy adults

Conditions: Pneumococcal Disease

Summary: the purpose of this study is to examine the safety, reactogenicity and immunogenicity of the glaxosmithkline (gsk) biologicals candidate pneumococcal vaccine containing phtd in healthy elderly population aged 18-45 years of age.

the safety profile of the phtd vaccine will be assessed in comparison to a comparator vaccine (pneumovax 23tm). in order to further increase the immune response to vaccination, a novel adjuvant system will also be examined.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 18 and 45 years at the time of the first vaccination. * written informed consent obtained from the subject. * free of obvious health problems 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, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * use of any anticoagulants. * planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines. * previous vaccination against streptococcus pneumoniae. * bacterial pneumonia within 3 years prior to 1st vaccination. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * current serious neurologic or mental disorders. * inflammatory processes such as known chronic active infections. * all malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. * history of administration of an experimental vaccine containing 3-deacylated monophosphoryl lipid a (mpl) or quillaja saponaria 21 (qs21). * acute disease at the time of enrolment. all vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature \<37.5°c or axillary temperature \<37.5°c. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator. * pregnant or lactating female. * history of chronic alcohol consumption and/or intravenous drug abuse.

Keywords: safety pneumococcal infections immunogenicity phtd vaccine healthy adults reactogenicity