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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00605085 |
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Date of registration:
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04/01/2008 |
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Primary sponsor: |
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Public title:
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Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
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Scientific title:
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Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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2990 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00605085 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Contacts
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Name:
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Astrid Kaltenboeck, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Intercell AG |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Japanese Encephalitis
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Intervention(s)
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Biological: Japanese Encephalitis purified inactivated vaccine (IC51)
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Biological: Placebo
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Primary Outcome(s)
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Safety and tolerability of IC51 until 4 weeks after the last vaccination
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Secondary Outcome(s)
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Rates of serious adverse events and medically attended adverse events
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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