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Clinical Trials/NCT01398540
NCT01398540CompletedPhase 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 enrollmentStarted: November 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
60
Primary Endpoint
cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

young

Experimental

subjects 18 to 40 years old, receiving 2 immunisations with IXIARO

Intervention: IXIARO (Biological)

elderly

Experimental

subjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO

Intervention: IXIARO (Biological)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Univ. Prof. Dr. Ursula Wiedermann

Univ.Prof. MD, PhD

Medical University of Vienna

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