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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01997632
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults 18-45 years of age
* Subjects born in Belgium or any other country where mandatory polio vaccination is performed.
* Written informed consent obtained from the subject.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
1. has practiced adequate contraception for 30 days prior to vaccination, and
2. has a negative pregnancy test on the day of vaccination, and
3. has agreed to continue adequate contraception for 2 months after vaccination.
Exclusion Criteria:
* Participation in another clinical trial.
* Any polio vaccine within 6 months before study inclusion.
* Any other vaccination in the period starting 14 days before administration of study vaccine and ending 28 days after administration of the study vaccine.
* Previous severe reaction after vaccination with polio vaccine.
* Known hypersensitivity to one or more components of the vaccine.
* Uncontrolled, clinically significant neuro-psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease.
* Subjects with an history of malignant disease (cancer)
* Known human immunodeficiency virus (HIV) positivity or other immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of \<20 mg/day, or equivalent, is allowed. Inhaled and topical corticosteroids are allowed.
* Acute disease and/or fever (higher or equal to 37.5°C, measured orally) at the time of enrolment. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory tract infection) without fever may be enrolled at the discretion of the investigator.
* Pregnant or lactating female. Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate for any other reason.
* Known hypersensitivity to one or more components of the vaccine.
* Uncontrolled, clinically significant neuro-psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease.
* Subjects with an history of malignant disease (cancer)
* Known human immunodeficiency virus (HIV) positivity or other immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of \<20 mg/day, or equivalent, is allowed. Inhaled and topical corticosteroids are allowed.
* Acute disease and/or fever (higher or equal to 37.5°C, measured orally) at the time of enrolment. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory tract infection) without fever may be enrolled at the discretion of the investigator.
* Pregnant or lactating female.
* Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate for any other reason.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01997632
Study Brief:
Protocol Section:
NCT01997632