Detailed analysis of the immune responses after vaccination against Japanese Encephalitis in the elderly.
Phase 1
- Conditions
- 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 65 years of age in comparison to subjects aged between 18 and 40 years.MedDRA version: 14.0Level: LLTClassification code 10069544Term: Japanese encephalitis immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2010-020450-33-AT
- Lead Sponsor
- Institute of Specific Prophylaxis and Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
adults (18-40 years and =65 years with no upper age limit), both sexes,
willingness to sign written informed consent form
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
age below 18 years, age between 41 and 64 years;
prior japanese encephalitis, TBE, dengue, yellow fever or West e virus infection,
yellow fever vaccination within the last 10 years, TBE vaccination within the last 30 days;
vaccination against dengue or West e Virus;
current acute infection (body temperature above 37,9°C)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method