Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change of antibody titer before and after influenza vaccination
研究概览
简要总结
The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).
详细描述
The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant females and aged more than 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.
- •Patients who receive hemodialysis therapy less than 3 months.
- •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;
- •Any severe illness needed to be hospitalization within three months.
- •Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
研究组 & 干预措施
the immunogenicity profiles of the AdimFlu-S
Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later.
Negative control group: dialysis patients who refused to receive influenza vaccination.
干预措施: AdimFlu-S (Drug)
结局指标
主要结局
Change of antibody titer before and after influenza vaccination
时间窗: 18 weeks
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.
次要结局
- Seroresponse rate(0, 3 weeks, 6 weeks, 9 weeks and 18 weeks)
- the safety and tolerability profiles of the vaccine(0, 3 week, 6 weeks, 9 weeks, 18 weeks)