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Clinical Trials/NCT01398540
NCT01398540
Completed
Phase 4

Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.

Medical University of Vienna0 sites60 target enrollmentNovember 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Humoral and Cellular Immune Responses
Sponsor
Medical University of Vienna
Enrollment
60
Primary Endpoint
cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
November 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Univ. Prof. Dr. Ursula Wiedermann

Univ.Prof. MD, PhD

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • adults (18-40 years old)
  • adults (≥60 years),
  • both sexes
  • willingness to sign written informed consent form

Exclusion Criteria

  • age below 18 years or between 41-59 years old
  • status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection
  • previous immunization against yellow fever, japanese encephalitis (dengue or WNV)
  • current acute infection (body temperature above 37,9°C)

Outcomes

Primary Outcomes

cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination

Time Frame: 7 days after the 2 JE vaccinations

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