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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00314132 |
The purpose of this study is to assess whether ChimeriVax-JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
Condition | Intervention | Phase |
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Encephalitis Virus, Vaccine |
Biological: ChimeriVax-JE, Japanese Encephalitis vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | H-040-010 |
Study First Received: | April 11, 2006 |
Last Updated: | April 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00314132 |
Health Authority: | United States: Food and Drug Administration; Australia: Therapeutic Goods Administration |
Virus Diseases Japanese encephalitis Central Nervous System Infections Central Nervous System Diseases |
Encephalitis, Japanese Arbovirus Infections Brain Diseases Encephalitis |
Encephalitis, Viral RNA Virus Infections Flaviviridae Infections Flavivirus Infections |
Nervous System Diseases Central Nervous System Viral Diseases Encephalitis, Arbovirus |