EUCTR2007-002872-32-DE进行中（未招募）不适用
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.
ovartis Vaccines and Diagnostics S.r.l.0 个研究点开始时间: 2007年8月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
- •2. able to comply with all study procedures and requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
- •2. fatal prognosis of an underlying medical condition (<12 months life expectancy);
- •3. history of Guillain-Barré syndrome;
- •4. bleeding diathesis or receiving anticoagulants of the coumarin type;
- •5. hospitalization or residence in a nursing care facility;
- •6. plans to receive seasonal influenza vaccine outside of this study;
- •7. receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
- •8. fever (defined as axillary temperature =38.0°C) or any acute illness within 3 days prior to study vaccination;
- •9. 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 of the observation period study;
- •10. any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives;
- •11. females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do 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 are considered acceptable forms of birth control.
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