Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01277705
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT01277705
Study Brief:
Protocol Section:
NCT01277705