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Immunogenicity and Safety of Verorab™ in Indian Population

NCT00260351 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2014-01-14

No results posted yet for this study

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.

Conditions

  • Rabies

Interventions

BIOLOGICAL

Purified Verocell Rabies Vaccine

0.1 mL, ID (TRC regimen)

BIOLOGICAL

Purified Verocell Rabies Vaccine

0.5 mL, IM (ZAGREB regimen)

BIOLOGICAL

Purified Verocell Rabies Vaccine

0.5 mL, IM (ESSEN regimen)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-08-31
Completion
2008-10-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00260351 on ClinicalTrials.gov