A clincal study to evaluate the safety of a polio vaccine type 2 given orally in healthy children aged 1 to 5 years previously treated with inactivated polio vaccine in Lithuania

Phase 1

• Conditions: evaluation of safety of SABIN mOPV2 in healthy IPV-vaccinated children of 1 – 5 years of age (Polio disease); MedDRA version: 18.0Level: LLTClassification code 10036016Term: Poliomyelitis NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-003544-39-LT
• Lead Sponsor: FIDEC - Fighting Infectious Diseases in Emerging Countries

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-18
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.1 to 5 years of age, previously vaccinated with three or four doses of IPV.
2.Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination.
3.Written informed consent obtained from 2 parents or legal guardian(s) as per country regulations

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Previous vaccination against poliovirus outside the national immunization schedule.
2.Polio vaccines including polio combined vaccines within the 3 months prior to the administration of the study vaccine (number of previous polio vaccine doses to be documented).
3.Any vaccine in the previous 4 weeks.
4.Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
5.Family history of congenital or hereditary immunodeficiency.
6.Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
7.Known allergy to any component of the study vaccines or to any antibiotics.
8.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
9.Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.).
10.Member of the subject’s household (living in the same house or apartment unit) has received OPV in the last 3 months.
11.Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.

Study & Design

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