NCT01411358已完成不适用
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40.
研究概览
简要总结
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or non-pregnant females and aged ≥ 18 years;
- •Willing and able to adhere to visit schedules and all study requirements;
- •Subjects read and signed the study-specific informed consent.
排除标准
- •Subject or his/her family is employed by the participated hospital;
- •Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
- •History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication
- •Personal or family history of Guillain-Barré Syndrome
- •An acute febrile illness within 1 week prior to vaccination;
- •Current upper respiratory illness, including the common cold or nasal congestion within 72 hours
- •Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough
- •Female subjects who are pregnant during the study
- •Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent
- •Immunodeficiency, or under immunosuppressive treatment
- •Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
- •Receipt of any blood products, including immunoglobulin in the prior 3 months;
- •Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine
结局指标
主要结局
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40.
时间窗: 3 weeks post vaccination
Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI).
次要结局
未报告次要终点
研究者
研究点 (1)
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