study of the dtap-ipv-hep b-prp~t combined vaccine following a primary series of dtacp ipv-hepb-prp-t or infanrix hexa™

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type B Infection

Summary: this is a follow-up of study a3l11 (nct00404651). immunogenicity * to describe the antibody persistence following a primary series vaccination of either dtap-ipv-hep b-prp\~t or infanrix hexa™. * to describe the immunogenicity of a booster dose of dtap-ipv-hepb-prp\~t in a subset of subjects. safety - to describe the safety profile after a booster dose of dtacp-ipv-hepb-prp\~t.


Eligibility criteria:
inclusion criteria: * toddlers previously included in study a3l11 (nct00404651) who completed the three-dose primary series vaccination of either dtap-ipv-hepb-prp-t or infanrix hexa™ at 2, 4 and 6 months of age * toddlers of 15 to 18 months (456 to 578 days) of age, inclusive * informed consent form signed by at least one parent or legal representative and two mandatory witnesses * 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 booster vaccination. * planned participation in another clinical trial during the present trial period. * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy. * 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 booster vaccination. * any vaccination planned until the next visit. * history of documented pertussis, tetanus, diphtheria, polio, haemophilus influenzae type b or hepatitis b (hb) infection(s) (confirmed either clinically, serologically or microbiologically). * administration of a vaccine against pertussis, tetanus, diphtheria, polio, hib, and/or hepatitis b infection(s) since the end of participation in study a3l11. * coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination. * known maternal history of human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c seropositivity. * subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in study a3l11. * history of seizures. * febrile (temperature ≥38.0°c) or acute illness on the day of inclusion * known contraindication to further vaccination with a pertussis vaccine, i.e.: encephalopathy; temperature \>40.0°c within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; inconsolable crying that occurred for \>3 hours within 48 hours following vaccine injection during the primary series; hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; seizures with or without fever within 3 days following vaccine injection.

Keywords: diphtheria tetanus pertussis hepatitis b poliomyelitis invasive haemophilus influenzae type b. haemophilus influenzae type b infection