evaluation of a booster dose of pneumococcal vaccine formulations in young adults

Conditions: Infections, Streptococcal

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.

Keywords: pneumococcal vaccine streptococcus pneumoniae young adults