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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01398540
Other study ID # IX-sensesc 1.2
Secondary ID
Status Completed
Phase Phase 4
First received July 19, 2011
Last updated March 26, 2018
Start date November 2010
Est. completion date November 2013

Study information

Verified date March 2018
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 2013
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
IXIARO
2 immunizations (0,5ml) with a 28 day interval

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Primary cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination 7 days after the 2 JE vaccinations