A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, (Adjuvanted With MF59C.1) Influenza Vaccine, Formulation 2005-2006, When Administered to Elderly Subjects.

Novartis3 个研究点分布在 1 个国家目标入组 50 人开始时间: 2005年6月1日最近更新: 2006年9月14日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Novartis
入组人数: 50
试验地点: 3
主要终点: CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

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

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.

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: 65 Years 至 —（Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•65 years of age or older and in good health

排除标准

•Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
•any acute disease or infections requiring systemic antibiotic or antiviral therapy
•hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
•history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
•known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days

结局指标

主要结局

CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

次要结局

Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

研究者

发起方

Novartis

申办方类型

Industry

研究点 (3)

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