safety and immunogenicity study of glaxosmithkline (gsk) biologicals' 10-valent pneumococcal conjugate vaccine

Conditions: Infections, Streptococcal

Summary: this study will evaluate safety, reactogenicity and immunogenicity of gsk biologicals' pneumococcal conjugate vaccine compared to prevenar™ when co-administered with dtpw-hbv/hib and opv or ipv vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age. the study has 2 groups. * one group of subjects will receive a 3-dose primary vaccination with the gsk biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated). * the 2nd group of subjects will receive a 3-dose primary vaccination with prevenar™. all children will receive concomitantly dtpw-hbv/hib and opv or ipv vaccines. this protocol posting deals with objectives \& outcome measures of the primary study. the objectives \& outcome measures of the booster study are presented in a separate protocol posting (nct number =00547248).

the protocol posting has been updated in order to comply with the fda amendment act, sep 2007

Eligibility criteria:
inclusion criteria: * male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination. * subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol * written informed consent obtained from the parent or guardian of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * born after a gestation period between 36 and 42 weeks. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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 the first vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3. * previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis b, haemophilus influenzae type b, and/or s. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations * history of or intercurrent diphtheria, tetanus, pertussis, hepatitis b, polio, and haemophilus influenzae type b diseases. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * history of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease. * acute disease at the time of enrolment * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical * a family history of congenital or hereditary immunodeficiency. * major congenital defects or serious chronic illness. * administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.

Keywords: immunogenicity safety pneumococcal vaccine pneumococcal disease