Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults
Condition: Streptococcus Pneumoniae; Haemophilus Influenzae
MeSH terms: Influenza, Human; Pneumonia; Pneumonia, Pneumococcal
Intervention: GSK2231395A; Engerix-B
Intervention description: Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. Two different formulations of this vaccine will be tested.; Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Non-typable Haemophilus influenzae; protein vaccine; Streptococcus pneumoniae; young adults

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.
    

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.