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Immunogenicity and Safety of Verorab™ in Indian Population

Primary Purpose

Rabies

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Purified Verocell Rabies Vaccine
Purified Verocell Rabies Vaccine
Purified Verocell Rabies Vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rabies focused on measuring rabies;, rabies post-exposure;, category III

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject with WHO category III rabies exposure Subject aged at least 2 years old (day of second birthday) Exclusion Criteria: Subject unable to comply with the follow-up schedule of the protocol Delayed post-exposure treatment (>72 hours between incident and treatment Subject bitten by an observable animal at the inclusion visit Subject with immune-compromised or underlying diseases which may lead to inferior immune response Subject with known pregnancy at the time of inclusion Subject enrolled or scheduled to be enrolled in another clinical study. Subject with acute febrile illness/ axillary temperature > 37.5 degree celsius Subject in whom blood sampling will be difficult. Subject receiving chloroquine or other anti-malarial treatment Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.) Previous rabies immunization Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin Subject with clinical signs of rabies Subject with known allergy to vaccine components (e.g. neomycin) Subject who received blood and/or plasma transfusion within the past 3 months

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Participants on Thai Red Cross, TRC-ID regimen

Participants on Zagreb-IM regimen

Participants on Essen-IM regimen.

Outcomes

Primary Outcome Measures

Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine

Secondary Outcome Measures

Full Information

First Posted
November 29, 2005
Last Updated
January 10, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00260351
Brief Title
Immunogenicity and Safety of Verorab™ in Indian Population
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 exposure,or, 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: To describe the immunogenicity profile of each regimen To assess the safety of the vaccine in each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
rabies;, rabies post-exposure;, category III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants on Thai Red Cross, TRC-ID regimen
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants on Zagreb-IM regimen
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Participants on Essen-IM regimen.
Intervention Type
Biological
Intervention Name(s)
Purified Verocell Rabies Vaccine
Other Intervention Name(s)
PVRV, VERORAB
Intervention Description
0.1 mL, ID (TRC regimen)
Intervention Type
Biological
Intervention Name(s)
Purified Verocell Rabies Vaccine
Other Intervention Name(s)
PVRV, VERORAB
Intervention Description
0.5 mL, IM (ZAGREB regimen)
Intervention Type
Biological
Intervention Name(s)
Purified Verocell Rabies Vaccine
Other Intervention Name(s)
PVRV, VERORAB
Intervention Description
0.5 mL, IM (ESSEN regimen)
Primary Outcome Measure Information:
Title
Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine
Time Frame
6 months post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with WHO category III rabies exposure Subject aged at least 2 years old (day of second birthday) Exclusion Criteria: Subject unable to comply with the follow-up schedule of the protocol Delayed post-exposure treatment (>72 hours between incident and treatment Subject bitten by an observable animal at the inclusion visit Subject with immune-compromised or underlying diseases which may lead to inferior immune response Subject with known pregnancy at the time of inclusion Subject enrolled or scheduled to be enrolled in another clinical study. Subject with acute febrile illness/ axillary temperature > 37.5 degree celsius Subject in whom blood sampling will be difficult. Subject receiving chloroquine or other anti-malarial treatment Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.) Previous rabies immunization Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin Subject with clinical signs of rabies Subject with known allergy to vaccine components (e.g. neomycin) Subject who received blood and/or plasma transfusion within the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Calcutta
Country
India
City
Hyderabad
Country
India
City
Lucknow
Country
India

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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Immunogenicity and Safety of Verorab™ in Indian Population

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