Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults

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.