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Clinical Trials/EUCTR2015-003544-39-LT
EUCTR2015-003544-39-LT
Active, not recruiting
Phase 1

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 sitesSeptember 18, 2015
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Conditionsevaluation 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: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsPolio Sabin TM Mono Two (oral)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
evaluation of safety of SABIN mOPV2 in healthy IPV-vaccinated children of 1 – 5 years of age (Polio disease)
Sponsor
FIDEC - Fighting Infectious Diseases in Emerging Countries
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 18, 2015
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FIDEC - Fighting Infectious Diseases in Emerging Countries

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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