Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults

Launched by GLAXOSMITHKLINE · Dec 23, 2008

Keywords

ClinConnect Summary

This Protocol Posting has been updated following amendment of the Protocol, January 2010. The sections impacted are: study design and study endpoints.

Gender

ALL

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.