An Immunogenicity and Safety Study of Modified TRC-ID Regimen With A New Chromatographically Purified Vero Cell Rabies Vaccine(SPEEDA/TRCS SPEEDA) and Rabies Immunoglobulin

Queen Saovabha Memorial Institute4 个研究点分布在 1 个国家目标入组 210 人开始时间: 2010年6月最近更新: 2018年4月6日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Queen Saovabha Memorial Institute
入组人数: 210
试验地点: 4
主要终点: immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

详细描述

Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and proven to be immunogenic and effective. It represents a significant saving in vaccine cost and is now established in several developing countries. SPEEDA,chromatography purified vero cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Single (Participant)

入排标准

年龄范围: 15 Years 至 60 Years（Child, Adult）
性别: All
接受健康志愿者: 是

入选标准

•subjects are healthy population older than 15 years.
•subjects are willing to give signed informed consents.
•subjects are willing to give blood samples on recommended days.
•subjects are available for follow up according to the table of administration

排除标准

•subjects who had received any type of rabies vaccination in the past
•subjects who had received rabies immunoglobulin in the past
•subjects who had known as immunocompromised hosts
•subjects on steroids or any other immunosuppressant
•subjects on concomitant antimalarials
•subjects who have received of any blood products within the previous 3 months
•subjects with history of allergy to any ingredient of the vaccine
•subjects who had known as pregnancy in first recruitment