临床试验/NCT00776438

NCT00776438已完成2 期

Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated Either With an Inactivated Influenza Vaccine Administered Via the Intradermal Route or an Inactivated Influenza Vaccine Administered Via the Intramuscular Route

Sanofi Pasteur, a Sanofi Company1 个研究点分布在 1 个国家目标入组 160 人开始时间: 2007年9月最近更新: 2015年6月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Sanofi Pasteur, a Sanofi Company
入组人数: 160
试验地点: 1
主要终点: To provide information concerning immune response to an inactivated, split-virion, influenza 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

To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations.

Objectives:

To describe the immune response per age group and vaccine group after vaccination.
To describe the safety of the vaccines per age group and per vaccine group after vaccination.

研究设计

研究类型: Interventional
分配方式: 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 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

To provide information concerning immune response to an inactivated, split-virion, influenza vaccine.

时间窗: 21 days post-vaccination

To provide information concerning the safety of inactivated, split-virion, influenza vaccine.

时间窗: 21 days post-vaccination and entire study duration

次要结局

未报告次要终点

研究者

发起方

Sanofi Pasteur, a Sanofi Company

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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