临床试验/NCT00415129

NCT00415129已完成2 期

Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Sanofi Pasteur, a Sanofi Company4 个研究点分布在 2 个国家目标入组 600 人开始时间: 2006年6月最近更新: 2014年1月14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: 600
试验地点: 4
主要终点: To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus 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

Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

研究设计

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

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

未提供

排除标准

未提供

结局指标

主要结局

To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine

时间窗: 21 Days post-vaccination

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 (4)

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