NCT00310648已完成3 期
Part 1:Phase I Open-Label, Single-Center to Evaluate the Safety of a Commercially Available Adjuvanted Influenza Vaccine When Administered to Elderly Subjects Part 2: A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Immunogenicity and Safety of a Commercially Available Influenza Vaccine and a Conventional Commercially Available Influenza Vaccine When Administered to Elderly Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Requirements For Drug Registration & Guide Principles For ClinicaL Trial Techniques of Vaccine e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
研究概览
简要总结
Clinical Trial in Two parts:
Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects.
Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects.
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
- Single
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry
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.
- •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 have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).
结局指标
主要结局
Requirements For Drug Registration & Guide Principles For ClinicaL Trial Techniques of Vaccine e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
次要结局
- Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.
研究者
研究点 (2)
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