临床试验/NCT01040741

NCT01040741已完成不适用

A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Focetria

Novartis Vaccines14 个研究点分布在 2 个国家目标入组 7,284 人开始时间: 2009年12月最近更新: 2011年10月5日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 7,284
试验地点: 14
主要终点: To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects.

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 observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 6 Months 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subject's age in accordance with the approved product label of the country where the study is conducted
•Subjects will be vaccinated with Focetria®, independently of this study.
•Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

排除标准

•Received any prior H1N1 vaccination

结局指标

主要结局

To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects.

时间窗: 6 Months

次要结局

To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine.(6 months)

研究者

发起方

Novartis Vaccines

申办方类型

Industry

责任方

Sponsor

研究点 (14)

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