临床试验/NCT00518453

NCT00518453已完成2 期

A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Novartis Vaccines1 个研究点分布在 1 个国家目标入组 129 人开始时间: 2007年7月1日最近更新: 2016年12月1日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 129
试验地点: 1
主要终点: evaluate the antibody response to each influenza vaccine antigen

研究概览研究设计入排标准研究组 & 干预措施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

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

研究设计

研究类型: Interventional
分配方式: Non 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 84 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

排除标准

•Any serious disease

研究组 & 干预措施

Arm 1: Fluvirin

Experimental

干预措施: Surface antigen inactivated influenza vaccine (Biological)

结局指标

主要结局

evaluate the antibody response to each influenza vaccine antigen

时间窗: 21 days post-immunization

次要结局

Safety and tolerability of the study vaccine in the study population(Throughout the study)

研究者

发起方

Novartis Vaccines

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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