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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00621764 |
Safety:
To describe the safety profiles following vaccination.
Immunogenicity:
To describe the immune response after a single dose of vaccine.
Condition | Intervention | Phase |
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Japanese Encephalitis Hepatitis A |
Biological: Japanese encephalitis vaccine (D0) Hepatitis A vaccine (D28) Biological: Hepatitis A vaccine (D0) Japanese encephalitis vaccine (D28) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children |
Estimated Enrollment: | 300 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Japanese encephalitis vaccine (D0) Hepatitis A vaccine (D28)
≥4.0 Log10 PFU, SC (Day 0); 0.5 mL IM (Day 28)
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2: Experimental |
Biological: Hepatitis A vaccine (D0) Japanese encephalitis vaccine (D28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
|
3: Experimental |
Biological: Japanese encephalitis vaccine (D0) Hepatitis A vaccine (D28)
≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
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4: Experimental |
Biological: Hepatitis A vaccine (D0) Japanese encephalitis vaccine (D28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
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This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts.
Ages Eligible for Study: | 12 Months to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur, Inc ( Medical Monitor ) |
Study ID Numbers: | JEC01 |
Study First Received: | February 12, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00621764 History of Changes |
Health Authority: | Thailand: Food and Drug Administration |
Japanese encephalitis (JE) Hepatitis A Inactivated Mouse-Brain |
Liver Diseases Japanese Encephalitis Picornaviridae Infections Encephalitis, Japanese Central Nervous System Diseases Hepatitis, Viral, Human Brain Diseases Encephalitis |
Hepatitis Virus Diseases Digestive System Diseases Central Nervous System Infections Hepatitis A Arbovirus Infections Enterovirus Infections |
Liver Diseases RNA Virus Infections Flaviviridae Infections Flavivirus Infections Nervous System Diseases Picornaviridae Infections Hepatitis, Viral, Human Encephalitis, Japanese Central Nervous System Diseases Central Nervous System Viral Diseases Brain Diseases |
Encephalitis Hepatitis Virus Diseases Encephalitis, Viral Digestive System Diseases Central Nervous System Infections Hepatitis A Enterovirus Infections Arbovirus Infections Encephalitis, Arbovirus |