Immunogenicity and Safety of Verorab™ in Indian Population

Rabies Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260351
• Other study ID #: RAB28
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2005
• Last updated: January 10, 2014
• Start date: December 2004
• Est. completion date: October 2008

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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:

1. To describe the immunogenicity profile of each regimen

2. To assess the safety of the vaccine in each group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• Purified Verocell Rabies Vaccine
0.1 mL, ID (TRC regimen)
• Purified Verocell Rabies Vaccine
0.5 mL, IM (ZAGREB regimen)
• Purified Verocell Rabies Vaccine
0.5 mL, IM (ESSEN regimen)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine		6 months post-vaccination	No

External Links

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