safety of hib-mency-tt vaccine versus licensed hib conjugate vaccine, given at 2, 4, 6 and 12 to 15 months of age

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Summary: the primary phase of this study is evaluating the safety of hib-mency-tt vaccine compared to a control group receiving licensed hib conjugate vaccine, when each are co-administered with pediarix® to healthy infants at 2, 4, and 6 months of age. this protocol posting deals with objectives \& outcome measures of the primary phase of the study. the objectives \& outcome measures of the booster phase are presented in a separate protocol posting (nct number = 00345683). the protocol posting has been updated in order to comply with the fda amendment act, sep 2007

pediarix/infanrix penta and prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

Eligibility criteria:
inclusion criteria: * subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * a male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * born after 36 weeks gestation. * infants who have not received a previous dose of hepatitis b vaccine or those who have received only 1 dose of hepatitis b vaccine administered at least 30 days prior to enrolment. * infants may have received a birth dose of bacillus calmette-guérin (bcg) vaccine. 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 since birth. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). * previous vaccination against neisseria meningitidis, haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis b vaccine. * in country(ies) where prevnar will be provided by gsk biologicals, previous vaccination with prevnar. * history of neisseria meningitidis, haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis b, and/or poliovirus disease. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * acute disease at time of enrollment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Keywords: prophylaxis neisseria meningitidis vaccines, conjugate infants meningococcal vaccines h. influenzae type b vaccine humans safety