immunogenicity study of antibody persistence and booster effect of dtap-hb prp~t combined vaccine in filipino infants

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza

Summary: dtap-hb-prp\~t combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance. primary objectives: * to describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either dtap-hb-prp\~t or tritanrix-hep b/hib™ given at 6, 10 and 14 weeks of age, and one dose of hepatitis b (hep b) vaccine given at birth. * to describe the effect of a booster dose of dtap-hb-prp\~t on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either dtap-hb-prp\~t or tritanrix hepb/hib™ given at 6, 10 and 14 weeks of age, and one dose of hep b vaccine given at birth. secondary objective: * to describe the safety profile of the booster dose of the dtap-hb-prp\~t vaccine when administered concomitantly with oral polio vaccine (opv).

this study will assess the immunogenicity and reactogenicity of the investigational dtap-hb-prp\~t combined vaccine when given as a booster dose, concomitantly with opv, in filipino children previously primed at 6, 10, and 14 weeks with the investigational dtap-hb-prp\~t combined vaccine or tritanrix-hep b/hib™ vaccine and having received a first dose of hep b vaccine (recomvax b™) at birth in a previous study, al201 (nct00348881).

Eligibility criteria:
inclusion criteria: * toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive) * participated in the al201 study and completed the three-dose primary series with either dtap-hb-prp\~t or tritanrix-hepb/hib™, and opv, at 6, 10 and 14 weeks of age, and received hepatitis b vaccine at birth * informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate) * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the trial vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months * known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion * blood or blood-derived products received in the last 3 months * any vaccination in the 4 weeks preceding the trial vaccination * vaccination planned in the 4 weeks following the trial vaccination * febrile (temperature ≥ 38.0°c) or acute illness on the day of inclusion * history of documented diphtheria, tetanus, pertussis, haemophilus influenzae type b, hepatitis b or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically) * vaccination with a vaccine containing diphtheria, tetanus, pertussis, haemophilus influenzae type b, hepatitis b or poliovirus 3 types antigen, since the end of the primary series * thrombocytopenia or a bleeding disorder contraindicating im vaccination * serious adverse event related to any vaccination in the al201 study.

Keywords: diphtheria tetanus pertussis hepatitis b hansenula (hb) haemophilus influenzae type b