Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260351
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2005-11-29
Brief Title:
Immunogenicity and Safety of Verorab in Indian Population
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity and Safety of Purified Vero Cell Rabies Vaccine PVRV Verorab Administered for Rabies Post-exposure Treatment Comparison of Essen-IM Zagreb-IM and Thai Red Cross TRC-ID Regimens in the Indian Population
Status:
COMPLETED
Status Verified Date:
2014-01
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:
To demonstrate that rabies vaccine administered according to the Thai Red Cross TRC-ID regimen 2-2-2-0-1-1 is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers GMTs at D28 in subjects with a WHO category III rabies exposureor
To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen 2-1-1 is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28 in subjects with a WHO category III rabies exposure
Secondary objectives
1 To describe the immunogenicity profile of each regimen
2 To assess the safety of the vaccine in each group
To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen 2-1-1 is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28 in subjects with a WHO category III rabies exposure
Secondary objectives
1 To describe the immunogenicity profile of each regimen
2 To assess the safety of the vaccine in each group
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