A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania

FIDEC - Fighting Infectious Diseases in Emerging Countries0 个研究点开始时间: 2015年9月18日最近更新: 2016年8月22日

适应症

试验速览

暂无简介。

•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

•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.

发起方

FIDEC - Fighting Infectious Diseases in Emerging Countries