Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441259
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2007-02-27
Brief Title:
Safety and Efficacy Study of ChimeriVax-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomised Double Blind Controlled Safety Tolerability and Immunogenicity Phase II Trial of ChimeriVax-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Children of Descending Age
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomised double-blind study is to be conducted on 96 subjects at multiple sites in India Subjects will be enrolled by age group and randomised to either ChimeriVax-JE JE-CV or JE Mouse Brain Derived Vaccine JE-MBDV Study consists of a screening period a treatment period and a 2 year follow-up period
Primary safety endpoints will be the adverse event AE rates 28 days after completion of vaccination course The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination
Primary safety endpoints will be the adverse event AE rates 28 days after completion of vaccination course The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None