comparison of gsk biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine, to boostrixtm and inactivated poliovirus vaccine administered separately and with revaxis®

Conditions: Tetanus; Diphtheria; Acellular Pertussis

Summary: this study will assess the immunogenicity and reactogenicity of the candidate gsk biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in germany and ≥ 18 years in france compared to boostrix™ and inactivated poliovirus vaccine administered separately, and with revaxis®


Eligibility criteria:
inclusion criteria: * a male or female subjects aged 15 years and over (germany), or 18 years and over (france) at the time of the vaccination. * written informed consent obtained. * free of obvious health problems having received primary vaccination with diphtheria and tetanus vaccines to the best of his/her knowledge. * female subjects must not be pregnant or lactating. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period. * history of previous or intercurrent diphtheria or tetanus, pertussis or polio disease in the last 10 years. * french subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years. * german subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 5 years, except those subjects participating in the tetanus antibody kinetic subgroup. * german subjects participating in the tetanus antibody kinetic subgroup: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years. * administration or planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the study vaccine dose and ending 30 days after study vaccination. * chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs within six months or 5 half-lives (whichever is the longer) of vaccination. * administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, * history of seizures or progressive neurological disease. * major congenital defects or serious chronic illness. * acute disease at the time of enrolment. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * the following adverse experiences associated with diphtheria-tetanus-pertussis vaccination constitute absolute contraindications to further administration of diphtheria-tetanus-pertussis vaccine; if any of these adverse experiences occurred following previous vaccinations, the subject should not be included: absolute contraindications: * hypersensitivity reaction due to the vaccine. * encephalopathy precautions: * fever \>= 40.0°c within 48 hours of vaccination not due to another identifiable cause. * collapse or shock-like state within 48 hours of vaccination. * persistent, inconsolable crying lasting \>= 3 hours occurring within 48 hours of vaccination. * seizures with or without fever occurring within 3 days of vaccination.

Keywords: booster vaccination