evaluation of non-typable haemophilus influenzae and pneumococcal protein vaccine formulations in young adults

Conditions: Streptococcus Pneumoniae; Haemophilus Influenzae

Summary: the purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable haemophilus influenzae and pneumococcal candidate vaccine in young adults. subjects will be vaccinated 2 times in an observer-blind manner with an interval of 2 months. the subjects receiving engerix-b will receive in an open-manner a third dose of the vaccine at month 6. the protocol posting has been updated following a protocol amendment.

this protocol posting has been updated following amendment of the protocol, january 2010. the sections impacted are: study design and study endpoints.

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 40 years of age at the time of the first vaccination. * written informed consent obtained from the subject. * subject without medical history, clinical finding or laboratory finding, which, in the opinion of the investigator, could pose a safety concern or interfere with the protocol. * if the subject is female, and of childbearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study. exclusion criteria: * pneumonia within 3 years prior to 1st vaccination. * invasive pneumococcal disease within 3 years prior to 1st vaccination. * 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. * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines, with the exception of the influenza vaccine which can be administered \>14 days prior to or \>14 days following vaccine doses 1 and 2. * administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * history of reaction or hypersensitivity to any component of the vaccine. * any serious, uncontrolled disease likely to interfere with the study as determined by history, physical examination or laboratory screening, as per the judgment of the investigator. * inflammatory processes such as known chronic infections. * all past or current malignancies and lymphoproliferative disorders. * laboratory evidence of haematological and biochemical abnormalities. * acute disease at the time of enrolment/vaccination. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions. * history of chronic alcohol consumption and/or drug abuse. * other conditions that the principal investigator judges may interfere with study findings. * previous vaccination for hepatitis b. as a portion of the subjects will be randomized to receive engerix-b comparator, it is important that all subjects meet engerix-b eligibility criteria.

Keywords: non-typable haemophilus influenzae protein vaccine streptococcus pneumoniae young adults