Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study

Valneva Austria GmbH0 个研究点目标入组 3,258 人开始时间: 2005年10月最近更新: 2014年7月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Valneva Austria GmbH
入组人数: 3,258
主要终点: Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

研究设计

研究类型: Observational
观察模型: Cohort

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy subjects at least 18 years of age
•Written informed consent obtained prior to study entry
•Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

排除标准

•Inability or unwillingness to provide informed consent and to abide the requirements of the study

结局指标

主要结局

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

时间窗: 24 months after the first vaccination

first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302

次要结局

Geometric Mean Titers(6, 12, 36, 48 and 60 months)
Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)(6, 12, 36, 48 and 60 months after 1st vaccination)
Adverse Events(6, 12, 24, 36, 48 and 60 months after 1st vaccination)

研究者

发起方

Valneva Austria GmbH

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

4 期

Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster DoseEncephalitis, Japanese

NCT02514746PATH561

已完成

3 期

Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese ToddlersJapanese EncephalitisMeaslesRubellaMumps

NCT01188343Sanofi Pasteur, a Sanofi Company542

尚未招募

3 期

ong Term Immunogenicity of the JE Vaccine IC51Prophylactic Vaccine against Japanese EncephalitisNeurological - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

ACTRN12605000681651Intercell AG600

进行中（未招募）

不适用

ONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINEIC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY - IC51-303Japanese encephalitis. This study is a follow-up to the pivotal immunogenicity and safety studies IC51-301 and IC51-302.

EUCTR2005-000253-29-DEIntercell AG3,300

进行中（未招募）

不适用

ONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINEIC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY - IC51-303

EUCTR2005-000253-29-ATIntercell AG3,300