comparison of gskbiologicals' hib-mency-tt vaccine vs licensed hib conjugate or meningococcal vaccine

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Summary: this study is evaluating the safety and immunogenicity of gsk biologicals' hib-mency-tt vaccine compared to a control group receiving licensed hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups a, c, y, and w-135 polysaccharide vaccine administered at 3 to 5 years of age. the safety and immunogenicity of a booster dose of hib-mency-tt vaccine will be compared to a booster dose of licensed hib conjugate vaccine, each administered at 12 to 15 months of age. the group primed with the hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of hib-mency-tt or a booster dose of the hib conjugate vaccine.

the non-inferiority of the immunogenicity, safety, and antibody persistence of hib-mency-tt vaccine will be compared to acthib®, a monovalent hib conjugate vaccine licensed in the us. all subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. the immunogenicity of the menc and meny antigens will be summarized. menc and meny immunogenicity will be compared to menomune® (a quadrivalent meningococcal a, c, y, and w-135 plain polysaccharide vaccine licensed in the us) administered to children 3 to 5 years of age. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * for groups a and b * subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * healthy 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. * free of obvious health problems as established by medical history and clinical examination before entering the study. * born after a gestation period between 36 and 42 weeks. * 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 enrollment. * for group c * subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * healthy male or female between, and including, 3 and 5 years of age at the time of the first vaccination. * 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 the study. exclusion criteria: -for groups a and b * 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 within 30 days of the first dose of study vaccine(s). * previous vaccination against neisseria meningitidis, haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or streptococcus pneumoniae; more than one previous dose of hepatitis b vaccine. * history of neisseria meningitidis, haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis b, poliovirus, and/or streptococcus pneumoniae 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 vaccine(s), 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. for group c * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine. * previous vaccination against neisseria meningitidis. * history of neisseria meningitidis 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 vaccine, including dry natural latex rubber * major congenital defects or serious chronic illness. * acute disease at time of enrollment. * administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.

Keywords: immunogenicity primary & booster vaccination infants meningococcal vaccine safety children hib disease meningococcal disease