Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK2189242A (formulation 1); Pneumococcal vaccine GSK2189242A (formulation 2)
Intervention description: One dose will be administered intramuscularly at Study Day 0.; One dose will be administered intramuscularly at Study Day 0.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 41 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccine; Streptococcus pneumoniae; Young adults

Summary:

      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a
      booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT 00707798)
    

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 41 years old at the time of
             vaccination.

          -  Subjects who previously participated in the study NCT00707798 and received one of the
             two investigational GSK2189242A vaccine formulations during the primary study.

          -  Written informed consent obtained from the subject.

          -  Free of obvious health problems as established by medical history, clinical
             examination and clinical laboratory assessment before entering into the study.

          -  Female subjects of non-childbearing potential (defined as pre-menarche, current tubal
             ligation, hysterectomy, ovariectomy or post-menopause) 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 vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the vaccination, or planned use during the
             study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to vaccination.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period starting 30 days prior to the vaccination and ending one month
             (minimum 30 days) after vaccination.

          -  Administration of any pneumococcal vaccine other than the study vaccine during the
             period between end of study NCT00707798 and study vaccination.

          -  Bacterial pneumonia within the period between end of study NCT00707798 and study
             vaccination.

          -  Invasive pneumococcal disease (IPD) within the period between end of study NCT00707798
             and study vaccination.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection (no laboratory testing required).

          -  History of thrombocytopenia or bleeding disorder.

          -  Anaphylactic reaction following the previous administration of the vaccine or history
             of reactions or allergic disease likely to be exacerbated by any component of the
             vaccine.

          -  Current serious neurologic or mental disorders.

          -  Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).

          -  All past or current malignancies (excluding non-melanic skin cancer) and
             lymphoproliferative disorders.

          -  Acute disease at the time of enrolment/vaccination.

          -  Fever at the time of vaccination. Fever is defined as temperature >= 37.5°C on oral
             setting.

          -  Physical examination positive for acrocyanosis, jaundice, splenomegaly.

          -  Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular,
             hematologic, hepatic or renal functional abnormality, as determined by physical
             examination or laboratory screening tests, at the discretion of the investigator

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding vaccination or planned administration during the study period.

          -  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.