Immunogenicity and Safety of Verorab™ in Indian Population

* 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.

Completed

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Key information

Conditions

Rabies Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hyderabad, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Purified Verocell Rabies Vaccine

Biological

0.1 mL, ID (TRC regimen)

Other names: PVRV, VERORAB

Primary outcomes

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

Time frame: 6 months post-vaccination

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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.

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Dec 1, 2005
Registry last updated: Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed