Evaluate Reactogenicity & Immunogenicity of Adjuvanted Influenza Vaccine in Elderly Adults Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Administered in Young & Elderly Adults Will be Used as Reference

GlaxoSmithKline2 个研究点分布在 1 个国家目标入组 200 人开始时间: 2006年10月最近更新: 2016年10月7日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 200
试验地点: 2
主要终点: Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine during the 21 days following administration of the vaccine

研究概览研究设计入排标准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

Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•The subjects must be healthy adults ages 18-40 years or >/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine.

排除标准

•Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination
•Have a history of influenza infection since previous vaccination
•Women who are pregnant
•Subjects who have an acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination

结局指标

主要结局

Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine during the 21 days following administration of the vaccine

次要结局

Evaluation of the humoral immune response and cell-mediated immune response 21 days after revaccination with candidate vaccine

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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