A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,654
- 试验地点
- 10
- 主要终点
- Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
研究概览
简要总结
The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and 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 (Participant)
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
- •18 to 60 years of age (first age group) OR over 60 years of age (second age group)
- •mentally competent to understand the nature, the scope and the consequences of the study
- •able and willing to give written informed consent prior to study entry
- •available for all the visits scheduled in the study
- •residence in the study area
- •in good health as determined by:
- •medical history,
- •physical examination,
- •clinical judgment of the investigator.
排除标准
- •unable or unwilling to give written informed consent to participate in the study
- •suffering from an acute infectious disease
- •any serious disease such as:
- •cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),_
- •autoimmune disease (including rheumatoid arthritis),
- •advanced arteriosclerotic disease or complicated diabetes mellitus,
- •chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
- •acute or progressive hepatic disease,
- •acute or progressive renal disease,
- •congestive heart failure
- •surgery planned during the study period
- •bleeding diathesis
- •history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- •known or suspected impairment/alteration of immune function resulting from:
- •receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy),
- •receipt of immunostimulants,
- •receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
- •high risk for developing an immunocompromising disease within the past 6 months
- •history of drug or alcohol abuse
- •laboratory confirmed influenza disease in the past 6 months
- •received influenza vaccine within the past 6 months
- •received another vaccine or any investigational agent within the past 60 days, or planned vaccination within 3 weeks following the study vaccination
- •any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days
- •pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days)
- •any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
结局指标
主要结局
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
时间窗: Before vaccination (day 1) and three weeks after vaccination (day 22)
Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70% in the ≥18 to ≤60 years of age group or \>60% in the ≥61 years of age group.
Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
时间窗: Three weeks after vaccination (day 22)
Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is \>2.5 in the ≥18 to ≤60 years of age group or \>2.0 in the ≥61 years of age group.
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
时间窗: Three weeks after vaccination (day 22)
Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer \<10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is \>40% in the ≥18 to ≤60 years of age group or \>30% in the ≥61 years of age group.
次要结局
- Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination(Up to 7 days postvaccination)