NCT00522067已完成2 期
A Phase II, Open Label, Uncontrolled, Multi-Center Study to Support Annual Strain Update and to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects Aged 18-64 Years Affected by Chronic Diseases
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2007年6月1日最近更新:
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
- 52
- 试验地点
- 1
- 主要终点
- Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc
研究概览
简要总结
This phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 64 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases: hypertension, heart disease, chronic obstructive pulmonary disease (COPD) or asthma, hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus
排除标准
- •Hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine;
- •History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
- •Known or suspected impairment/ alteration of immune function;
- •Having received within the past 12 months more than one injection of influenza vaccine
- •Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
研究组 & 干预措施
Arm 1
Experimental
FLUAD
干预措施: Adjuvanted influenza vaccine (Biological)
结局指标
主要结局
Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc
To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.
次要结局
未报告次要终点
研究者
研究点 (1)
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