Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51
NCT ID: NCT00595790
Last Updated: 2014-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
374 participants
INTERVENTIONAL
2005-09-30
2007-11-30
Brief Summary
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Detailed Description
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Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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IC51 2 x 6 mcg
2 x 6 mcg (microgram)
IC51
IC51 1 x 12 mcg
1 x 12 mcg (microgram)
IC51
IC51 1 x 6 mcg
1 x 6 mcg (microgram)
IC51
Interventions
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IC51
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained prior to study entry
Exclusion Criteria
* History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
* 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
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
* History of autoimmune disease
* Any acute infections within 4 weeks prior to enrollment
* Infection with HIV, Hepatitis B or Hepatitis C
* Pregnancy, lactation or unreliable contraception in female subjects
18 Years
ALL
Yes
Sponsors
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Valneva Austria GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Susanne Eder, Mag.
Role: STUDY_DIRECTOR
Valneva Austria GmbH
Other Identifiers
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IC51-304
Identifier Type: -
Identifier Source: org_study_id
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