Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
Phase 3
Completed
- Conditions
- Japanese Encephalitis
- Interventions
- Biological: Japanese Encephalitis purified inactivated vaccine (IC51)Biological: Placebo
- Registration Number
- NCT00605085
- Lead Sponsor
- Valneva Austria GmbH
- Brief Summary
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2675
Inclusion Criteria
- At least 18 years of age
- 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 (e.g. JE-VAX®)
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Japanese Encephalitis purified inactivated vaccine (IC51) IC51 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Safety and Tolerability up to Day 56 Day 56 calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method Changes in Laboratory Parameters until Day 56 Rates of Serious Adverse Events and Medically Attended Adverse Events until Day 56 SCR and GMT of Subjects With Concomitant Vaccinations until Day 56