NCT01398540

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2010

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

July 19, 2011

Last Update Submit

March 26, 2018

Conditions

Humoral and Cellular Immune Responses

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

elderly

EXPERIMENTAL

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

Biological: IXIARO

young

EXPERIMENTAL

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

Biological: IXIARO

Interventions

IXIAROBIOLOGICAL

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

elderlyyoung

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ursula Wiedermann, MD, PhD

    Institute of Specific Prophylaxis and Tropical medicine, Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.Prof. MD, PhD

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 20, 2011

Study Start

November 1, 2010

Primary Completion

October 1, 2012

Study Completion

November 1, 2013

Last Updated

March 29, 2018

Record last verified: 2018-03