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.

Status Active, not recruiting

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. ;

Related Conditions & MeSH terms

• Rabies
• Virus Diseases

• NCT number: NCT02545517
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 5, 2015
• Completion date: November 18, 2022