A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before in the V58P4 Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,235
- 试验地点
- 10
- 主要终点
- Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine
研究概览
简要总结
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 < 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
- •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
- •in good health as determined by:
- •Medical history related to the previous six months,
- •Physical examination,
- •Clinical judgment of the investigator.
排除标准
- •Unwilling or unable to give written informed consent to participate in the study
- •Currently experiencing an acute infectious disease
- •Any serious disease such as, for example:
- •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
- •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 expect to receive another vaccine within 3 weeks following the study vaccination
- •Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
- •Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever _ 38°C within the past 5 days
- •Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
- •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
cTIV\cTIV (adults)
Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
干预措施: Cell culture derived influenza vaccine (Biological)
cTIV\TIV (adults)
Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
干预措施: egg-derived influenza subunit vaccine (Biological)
cTIV\cTIV (elderly)
Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
干预措施: Cell culture derived influenza vaccine (Biological)
cTIV\TIV (elderly)
Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
干预措施: egg-derived influenza subunit vaccine (Biological)
TIV\TIV (adults)
Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
干预措施: egg-derived influenza subunit vaccine (Biological)
TIV\cTIV (adults)
Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
干预措施: Cell culture derived influenza vaccine (Biological)
TIV\TIV (elderly)
Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
干预措施: egg-derived influenza subunit vaccine (Biological)
TIV\cTIV (elderly)
Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
干预措施: Cell culture derived influenza vaccine (Biological)
结局指标
主要结局
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine
时间窗: Day 1 to Day 7 postvaccination
To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .
次要结局
- Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine(Up to 6 months postvaccination)
- Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects(Day 22 postvaccination)
- Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects(Day 22 postvaccination)
- Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.(Day 22 postvaccination)
- Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.(Day 22 postvaccination)