study to evaluate the safety and immunogenicity of a 10-valent pneumococcal conjugate vaccine in preterm infants

Conditions: Infections, Streptococcal

Summary: this study aims to evaluate the safety, reactogenicity and immunogenicity of glaxosmithkline (gsk) biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis b virus-inactivated polio virus/haemophilus influenzae type b (dtpa-hbv-ipv/hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life. 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 = 00609492)

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

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol * a male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * born after a gestation period of \>27 weeks (at least 189 days). * if full term born, healthy subjects as established by medical history and clinical examination before entering into the study * if premature, medically stable condition (not requiring significant medical support or ongoing management for debilitating disease and having demonstrated a clinical course of sustained recovery). exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose. * planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to visit 6. * previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis b, haemophilus influenzae type b, neisseria meningitidis and/or streptococcus 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, haemophilus influenzae type b disease, neisseria meningitidis. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * history of any neurologic disorders or seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past). * acute disease at the time of enrolment. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * a family history of congenital or hereditary immunodeficiency. * major congenital defects or serious chronic illness. * administration of immunoglobulins, with the exception of monoclonal antibodies against rsv, and/or any blood products within one month preceding the first dose of study vaccines or planned administration during the active phase of the study.

Keywords: pneumococcal vaccine preterm safety pneumococcal disease immunogenicity