A vaccine study in healthy adults to evaluate the safety and immune response of a licensed oral polio vaccine containing 3 polio vaccine strains.

Phase 1

• Conditions: Historic tOPV can result in the emergence of circulating vaccine-derived polioviruses (cVDPVs): the attenuated strains of poliovirus from the vaccine infect un-immunized individuals, replicate, circulate in the population, and may eventually mutate enough to become virulent and effect vaccine-associated paralytic poliomyelitis (VAPP).; MedDRA version: 18.0Level: HLTClassification code 10036017Term: Poliomyelitis viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-003324-32-BE
• Lead Sponsor: niversity of Antwerp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-25
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 128

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 this 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 128
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
11. Participation in another clinical study within 28 days prior to entry in this study or receipt of any investigational product (drug or vaccine) other than the study vaccine within 28 days prior to the first administration of study vaccine, or planned use during the study period
12. Planned administration or administration of any vaccine other than the study vaccine within 28 days of the first dose of study vaccine and up to 28 days after administration of each study vaccine dose
13. Administration of polio vaccine within 12 months before the start of the study
14. Having had a transfusion of any blood product or application of immunoglobulins within the 4 weeks prior to the first administration of study vaccine or during the study
15. Subject is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, or is a family member of an employee or the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified