Safety and Tolerability Study of the JE Vaccine IC51
Phase 3
- Conditions
- Prophylactic Vaccine against Japanese EncephalitisNeurological - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12605000680662
- Lead Sponsor
- Intercell AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Written informed consent obtained prior to study entry.
Exclusion Criteria
Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine- History of any previous JE vaccination- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy- A family history of congenital or hereditary immunodeficiency- History of autoimmune disease- Any acute infections within 2 weeks prior to enrollment- Known or suspected HIV Infection- Pregnancy, lactation or unreliable contraception in female subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to investigate the safety of IC51 during the vaccination period until 4 weeks after the last vaccination compared with an inactive control[];The primary objective is to investigate the tolerability of IC51 during the vaccination period until 4 weeks after the last vaccination compared with an inactive control[]
- Secondary Outcome Measures
Name Time Method Rates of serious adverse events and medically attended adverse events in individuals.[Before and after immunization with IC51 up to day 56.]