anti-hep b antibodies at age 9 to 10 years after hep b vaccine at birth and dtap-ipv-hep b-prp-t hexavalent vaccine.

Conditions: Hepatitis B

Summary: the aim of the study is to assess the persistence of anti-hep b antibody at 9 to 10 years of age after the last priming dose in subjects who completed study a3l12 (nct00401531), and also evaluate the immune response against hepatitis b one month after vaccination (challenge vaccination) with a stand alone monovalent hepatitis b vaccine. primary objectives: * to describe the persistence of anti-hepatitis b antibody at 9 to 10 years of age after last priming dose in subjects having received hepatitis b vaccine at birth and a hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during a3l12 study (hexaxim® \[group 1\] or infanrix® hexa \[group 2\]) * to evaluate the immune response against hepatitis b one month after vaccination with a stand alone monovalent hepatitis b vaccine (challenge vaccination). secondary objectives: * to describe serious adverse events (saes) reported throughout the trial after administration of hepatitis b vaccine.

subjects age 9 to 10 years who had received 3 injections of hexaxim® or infanrix® hexa and have completed the a3l12 study will be invited to participate in this study. they will receive one dose of euvax-b® vaccine at day 0.

Eligibility criteria:
inclusion criteria: * informed consent form signed by subject's parent/legally acceptable representative * assent form signed by subject * subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures * receipt of primary vaccination with 3 doses of either hexaxim® or infanrix® hexa at the age of 2, 4, and 6 months in the a3l12 study, and hepatitis b vaccine at birth. exclusion criteria: * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial * incomplete primary immunization in the a3l12 study * diagnostic of hepatitis b infection (clinical, serological, or virological confirmation) after completion of a3l12 study procedures * subjects known to have received hepatitis b vaccine after completion of the a3l12 study procedures * receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for bacille calmette guerin (bcg) vaccination (any administration of oral polio vaccine \[opv\] in the context of oral polio vaccine-national immunization days \[opv-nids\] does not fall within the scope of this exclusion criterion) * receipt of any blood, blood-derived products or immunosuppressant drugs at the latest 3 months before inclusion * known or suspected diagnostic of congenital or acquired immunodeficiency since completion of the a3l12 study procedures * serious chronic illness occurring after receipt of the primary series (e.g., leukemia, lymphoma \[t or b cells\], crohn's disease) * known or suspected subject seropositivity against human immunodeficiency virus (hiv) or hepatitis c since completion of the a3l12 study procedures * febrile (temperature ≥ 38.0°c) or acute, moderate or severe systemic illness on the day of inclusion.

Keywords: hepatitis b dtap-ipv-hep b-prp-t hexavalent vaccine euvax-b® hexaxim® infanrix® hexa