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A Clinical Study to Evaluate Immune Responses to Rabies Vaccine in Adults Who Received Different Primary Rabies Vaccination Regimens

Virus Diseases Clinical Trial

Official title:
A Phase 3, Open-label, Multicenter Study to Evaluate Long-term Immunogenicity and Boostability of Immune Responses in Adults Who Received Different Primary Vaccination Regimens of Pre-exposure Prophylaxis With Purified Chick-Embryo Cell Rabies Vaccine Administered Concomitantly or Separately From a Japanese Encephalitis Vaccine.

Clinical Trial Summary

GlaxoSmithKline (GSK) Biologicals' Rabipur vaccine is indicated for active immunization against rabies in individuals of all ages. This includes pre-exposure prophylaxis (PrEP), in both primary series and booster dose, and post exposure prophylaxis.The aim of this extension study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in subjects who received a primary series of accelerated or conventional rabies PrEP IM regimen No new subjects were enrolled in this study.

Clinical Trial Description

The protocol was amended to clarify: - Timeframe between each yearly scheduled visit, - Number of additional booster doses a subject may receive depending on the RVNA level reached, - Premature withdrawal from the study - Exclusion criteria on scheduled visits - That only SAEs experienced by subjects who received the booster must be reported - Rewording of the protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02545517
Study type Interventional
Source GlaxoSmithKline
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 5, 2015
Completion date November 18, 2022
View Details
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