Immunogenicity and Safety of Verorab™ in Indian Population

Sanofi

Status and phase: Completed; Phase 4

Conditions: Rabies

Treatments: Biological: Purified Verocell Rabies Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00260351

RAB28

Details and patient eligibility

About

• 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.

Enrollment: 405 patients

Sex: All

Ages: 2+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 3 patient groups

Group 1

Experimental group

Description:

Participants on Thai Red Cross, TRC-ID regimen

Treatment:

Biological: Purified Verocell Rabies Vaccine

Biological: Purified Verocell Rabies Vaccine

Biological: Purified Verocell Rabies Vaccine

Group 2

Experimental group

Description:

Participants on Zagreb-IM regimen

Treatment:

Biological: Purified Verocell Rabies Vaccine

Biological: Purified Verocell Rabies Vaccine

Biological: Purified Verocell Rabies Vaccine

Group 3

Experimental group

Description:

Participants on Essen-IM regimen.

Treatment:

Biological: Purified Verocell Rabies Vaccine

Biological: Purified Verocell Rabies Vaccine

Biological: Purified Verocell Rabies Vaccine