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Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen

Rabies Clinical Trial

Official title:
Verorab® Immunogenicity and Safety After a One-week, 4-site, Intradermal (ID) Post-exposure Prophylaxis Regimen (4-4-4-0-0) Followed by a One-visit, 4-site, ID Booster at Five Years

Clinical Trial Summary

The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen. Primary objective: - To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen. Secondary objectives: - Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90. - Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group. - Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5. - Safety: To describe the safety profile of each group after the primary and booster vaccinations.

Clinical Trial Description

Participants with WHO Category II exposure will receive PEP, using "one-week, 4-site" ID vaccination regimen. Participants with WHO Category III exposure will receive PEP, using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab® or using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®. All participants will receive a "single-visit, 4-site" booster vaccination five years later. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01622062
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date June 29, 2012
Completion date November 14, 2018
View Details
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