NCT00560066已完成4 期
A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Novartis Vaccines15 个研究点 分布在 1 个国家目标入组 1,398 人开始时间: 2007年11月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,398
- 试验地点
- 15
- 主要终点
- Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV
研究概览
简要总结
Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.
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
- •Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
- •Able to comply with all study procedures and requirements.
排除标准
- •History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
- •Fatal prognosis of an underlying medical condition (<12 months life expectancy);
- •History of Guillain-Barre syndrome;
- •Bleeding diathesis or receiving anticoagulants of the coumarin type;
- •Hospitalization or residence in a nursing care facility;
- •Planned to receive seasonal influenza vaccine outside of this study;
- •Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
- •Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
- •Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the study;
- •Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives;
- •Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.
结局指标
主要结局
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV
时间窗: From Day 1 up to and including Day 7 post-vaccination
Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.
次要结局
- Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV(From Day 1 through Day 7 post-vaccination)
- Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV(From Day 1 through Day 7 post-vaccination)
- Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV(Before vaccination (Day 1) and three weeks after vaccination (Day 22))
- Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV(Three weeks post-vaccination (Day 22))
- Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV(Before vaccination (Day 1) and three weeks after vaccination (Day 22))
- Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV(Three weeks post-vaccination (Day 22))
研究者
研究点 (15)
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