A Phase IV, Open Label Study to Evaluate the Short and Long Term Immune Response and CROSS-protection After Vaccination With viroSOME Adjuvanted Inflexal V in Elderly Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Seroconversion
研究概览
简要总结
A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male adults aged >60 years on the day of enrollment
- •Written informed consent
- •Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)
排除标准
- •Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- •Acute febrile illness (≥38.0 °C)
- •Prior vaccination with an influenza vaccine for season 2011/2012
- •Known hypersensitivity to any vaccine component
- •Previous history of a serious adverse reaction to influenza vaccine
- •History of egg protein allergy or severe atopy
- •Known blood coagulation disorder
- •Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/day prednisolone or equivalent (inhaled or topical steroids are allowed)
- •Known immunodeficiency (including leukemia, HIV seropositivity) or cancer
- •Investigational medicinal product received in the past 3 months (90 days)
- •Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
- •Participation in another clinical trial
- •Employee at the investigational site or relative of the investigator
- •Anticipated non-compliance with study procedures
研究组 & 干预措施
All subjects
干预措施: Inflexal V (Biological)
结局指标
主要结局
Seroconversion
时间窗: 3 weeks after vaccination (Day 22 ± 2 days)
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Seroprotection
时间窗: 3 weeks after vaccination (Day 22 ± 2 days)
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Geometric Mean Titer
时间窗: 3 weeks after vaccination (Day 22 ± 2 days)
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
次要结局
- Seroprotection(6 months post-vaccination)
- Geometric Mean Titer(6 months post-vaccination)
- Seroconversion(6 months post-vaccination)