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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00735644 |
This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months.
Primary objective:
To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur.
Secondary objective:
To describe the safety of vaccination in all subjects
Condition | Intervention | Phase |
---|---|---|
Japanese Encephalitis Hepatitis A |
Biological: Japanese encephalitis vaccine Biological: Japanese encephalitis vaccine (Acambis) Biological: Hepatitis A vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Lot-to-Lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines |
Estimated Enrollment: | 1200 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Vaccine Lot 1
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Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
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2: Experimental
Vaccine Lot 2
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Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
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3: Experimental
Vaccine Lot 3
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Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
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4: Active Comparator |
Biological: Japanese encephalitis vaccine (Acambis)
0.5 mL, Subcutaneous
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5: Sham Comparator |
Biological: Hepatitis A vaccine
0.5 mL, Intramuscular
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This is a Phase III trial in toddlers in Thailand and the Philippines.
Ages Eligible for Study: | 12 Months to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Contact: Public Registry Sanofi Pasteur. | RegistryContactUs@sanofipasteur.com |
Philippines | |
Recruiting | |
Muntinlupa City, Philippines, 1781 | |
Thailand | |
Recruiting | |
Bangkok, Thailand, 10330 | |
Recruiting | |
Khon Kaen, Thailand, 40002 | |
Recruiting | |
Bangkok, Thailand, 10400 |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | JEC02 |
Study First Received: | August 14, 2008 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00735644 |
Health Authority: | Philippines: Department of Health; Thailand: Food and Drug Administration |
Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain |
Liver Diseases Picornaviridae Infections Encephalitis, Japanese Central Nervous System Diseases Hepatitis, Viral, Human Brain Diseases Encephalitis Hepatitis |
Virus Diseases Japanese encephalitis Digestive System Diseases Central Nervous System Infections Hepatitis A Arbovirus Infections Enterovirus Infections |
RNA Virus Infections Flaviviridae Infections Flavivirus Infections Encephalitis, Viral |
Encephalitis, Arbovirus Nervous System Diseases Central Nervous System Viral Diseases |