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OpenTrials
Completed

NCT Number: NCT01398540

Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IXIARO

Biological

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 20, 2011
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.