A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
研究概览
简要总结
The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to <61 years of age
- •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
- •in good health as determined by:
- •medical history,
- •physical examination,
- •clinical judgment of the Investigator.
排除标准
- •unwilling or unable to give written informed consent to participate in the study
- •participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
- •currently experiencing an acute infectious disease
- •any serious disease, such as, for example:
- •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
- •history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
- •known or suspected impairment/alteration of immune function, for example resulting from:
- •receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
- •receipt of immunostimulants,
- •receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
- •high risk for developing an immunocompromising disease
- •history of drug or alcohol abuse
- •laboratory-confirmed influenza disease within 6 months prior to Visit 1
- •receipt of influenza vaccine within 6 months prior to Visit 1
- •receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
- •any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
- •if female, pregnant or breastfeeding
- •if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
- •planned relocation abroad during the study period
- •any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
研究组 & 干预措施
TIV group
干预措施: Egg-Derived Trivalent Subunit Influenza Vaccine (TIV) (Biological)
cTIV_lot 1
干预措施: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV) (Biological)
cTIV_lot 2
干预措施: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV) (Biological)
cTIV_lot 3
干预措施: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV) (Biological)
结局指标
主要结局
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
时间窗: Day 22 postvaccination
Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5.
Percentage of Subjects With HI Titers ≥40
时间窗: Day 22 postvaccination
Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70%.
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
时间窗: Day 22 postvaccination
Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after 1. one dose of cTIV for each of the three vaccine lots separately and 2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is \>40%. As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
时间窗: Day 22 postvaccination
The haemagglutinin Inhibition (HI) antibody titer response following 1. one dose of cTIV for each of the three lots separately and 2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs). The HI GMTs were evaluated using egg-derived antigen assay.
次要结局
- Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine(Day 1 - Day 181 postvaccination)
- Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.(Day 1 to Day 7 postvaccination)