immunogenicity and safety of primary and booster vaccination with dtpa-hbv-ipv/hib vaccine

Conditions: Hepatitis B

Summary: this study will assess the immunogenicity, safety and reactogenicity of gsk biological's dtpa-hbv-ipv/ hib vaccine as compared to gsk's dtpa-ipv/hib vaccine co-administered with hbv according to a three-dose immunisation course and as a booster dose in infants born to hepatitis b antigen seronegative mothers and previously primed with a birth dose of gsk's hbv vaccine.


Eligibility criteria:
inclusion criteria: inclusion criteria for enrolment at birth * written informed consent obtained from the parents or guardians of the subject. * a male or female infant born after a normal gestation period (between 36 and 42 weeks). * born to a mother seronegative for hbsag. * free of obvious health problems as established by clinical examination before entering into the study. inclusion criteria for administration of the combined vaccine regimen * between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study. inclusion criteria for administration of the booster dose * between, and including, 15 and 18 months of age at the time of the booster vaccination. * written informed consent obtained from the parents or guardians of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * completion of the three-dose primary vaccination course. exclusion criteria: exclusion criteria for enrolment at birth * a family history of congenital or hereditary immunodeficiency. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * major congenital defect(s). exclusion criteria for administration of the combined vaccine regimen * use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration immunosuppressants or other immune-modifying drugs since birth. * any chronic drug therapy to be continued during the study period. * planned administration/ administration of a vaccine except bacille calmette-guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after. * previous vaccination against diphtheria, tetanus, pertussis or haemophilus influenzae type b disease. * history of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis b and/or haemophilus influenzae type b disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * serious chronic illness. * history of any neurologic disorders or seizures. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. exclusion criteria for administration of the booster dose * use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months of vaccination. * previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis b, polio and/or haemophilus influenzae type b. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * history of any neurologic disorders or seizures. * administration of immunoglobulins and/or any blood products within the three months preceding the booster dose of study vaccine or planned administration during the study period. * hypersensitivity reaction due to vaccine in primary course * encephalopathy within 7 days of previous vaccination with dtp vaccine