临床试验/NCT00491985

NCT00491985已完成2 期

Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

Sanofi Pasteur, a Sanofi Company1 个研究点分布在 1 个国家目标入组 240 人开始时间: 2007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: 240
试验地点: 1
主要终点: To describe safety following administration of A/H5N1 inactivated split virion pandemic 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

This is an open, randomized, multicenter clinical trial.

Objectives:

To describe the safety profiles during the 21 days following each primary and booster injection.
To describe the immune response 21 days after each primary and booster injection of each formulation.
To describe the antibody persistence after the first 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: 6 Months 至 18 Years（Child, 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 describe safety following administration of A/H5N1 inactivated split virion pandemic influenza 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 (1)

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