vaccination with gsk 1024850a in children primed with gsk 1024850a & boosted with pneumovax 23™

Conditions: Infections, Streptococcal; Streptococcus Pneumoniae

Summary: the aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of gsk 1024850a or prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (pneumovax 23™) vaccine at 11-14 months of age. antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either gsk 1024850a or prevenar™ vaccine followed by a booster dose of pneumovax 23™. this protocol posting deals with objectives \& outcome measures of the extension phase at year 4. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct 00307541). the objectives \& outcome measures of the booster phase are presented in a separate protocol posting (nct 00333450).


Eligibility criteria:
inclusion criteria: * male or female between, and including, 46-50 months of age at the time of vaccination. * subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * subjects who previously participated in study nct00333450 in centres with more than 2 subjects and received a booster dose of pneumovax 23™. * written informed consent obtained from both parents/guardians of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period. * administration of any pneumococcal vaccine since the end of study nct00333450. * administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical * history of any neurologic disorders or seizures * anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine. * history of hypotonic-hyporesponsive episode after any previous vaccination. * major congenital defects or serious chronic illness. * history of invasive pneumococcal diseases. * acute disease at the time of vaccination * rectal temperature \>= 38.0°c or oral/axillary/tympanic temperature \>= 37.5°c. a temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

Keywords: haemophilus influenzae streptococcus pneumoniae safety pneumococcal conjugate vaccine immunogenicity