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®

This is an interventional prevention trial for Tetanus focused on measuring Booster vaccination Read More

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.