EUCTR2015-003325-33-BE
Active, not recruiting
Phase 1
A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy OPV-vaccinated adults
niversity of Antwerp0 sites100 target enrollmentAugust 25, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Polio disease
- Sponsor
- niversity of Antwerp
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy male or female, between 18 and 50 years old, extremes included
- •2\. Received at least 4 doses of OPV in the past (more than 12 months before the start of the study)
- •3\. In good physical and mental health as determined on the basis of medical history and general physical examination performed at Day 0
- •4\. Female subjects of childbearing potential must agree to the use of an effective method of birth control throughout the study and up to 3 months after last vaccine dose
- •5\. Willing to adhere to the prohibitions and restrictions specified in the protocol
- •6\. Informed Consent Form (ICF) signed voluntarily by the subject before any study\-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
Exclusion Criteria
- •1\. A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements
- •2\. Having Crohn’s disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel
- •3\. A known allergy, hypersensitivity, or intolerance to the study vaccine, or to any of its components, or to any antibiotics
- •4\. Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus \[HIV] infection)
- •5\. Will have household or professional contact with known immunosuppressed people or people without full polio vaccination (i.e. complete priming) within 28 days after vaccination
- •6\. Neonatal nurses or others having professional contact with children under 6 months old within 28 days after vaccination
- •7\. Chronic administration (i.e., longer than 14 days) of immunosuppressant drugs or other immune\-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study. For instance, for corticosteroids, this means prednisone, or equivalent, \= 0\.5 mg/kg/day (inhaled and topical steroids are allowed, whereas intra\-articular and epidural injection/administration of steroids are not allowed)
- •8\. Presence of contraindications to administration of the study vaccine on Day 0: acute severe febrile illness deemed by the Investigator to be a contraindication for vaccination or persistent diarrhea or vomiting
- •9\. Indications of drug abuse or excessive use of alcohol at Day 0
- •10\. Being pregnant or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test at Day 0\. Subjects with a positive pregnancy test will be excluded
Outcomes
Primary Outcomes
Not specified
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