A clinical trial to measure immune responses following the first booster immunisation with the Japanese Encephalitis vaccine IXIARO® in elderly compared to young individuals.

Phase 1

• Conditions: The condition under investigation is the naturally aging immune system. The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group.; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-002894-36-AT
• Lead Sponsor: Medical University of Vienna (MUW)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-20
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

- participation in the preceeding study IXIARO®-senescence (EudraCTno: 2010-018630-52) without protocoll violation OR 2 documented IXIARO® vaccinations 28 days (-8/+ 30 days) apart between January 2010 and April 2014 at the age of 18 to 40 years or above the age of 60.
-good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM)
-willingness to sign written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

- Already received an booster (3rd dose) of IXIARO ®
- past infection with the JEV
- yellow fever vaccination within the last 6 months
- TBE vaccination within the last 30 days
- current acute infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified