EUCTR2016-001557-41-BE进行中（未招募）1 期
A Phase III, Multi-center, Single-dose, Randomized, Double-blind, Non-inferiority and Lot-to-lot Consistency Study of Immunogenicity and Safety Evaluation of AdimFlu-S Quadrivalent Inactivated Influenza Vaccine (QIS) versus Fluarix Tetra Vaccine in Healthy Subjects.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,100
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. Males or non-pregnant females and aged =18 years;
- •2. Stable health status is defined by the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment;
- •3. Willing and able to adhere to visit schedules and all study requirements. If necessary, the burden of a site visit can be removed by a subject-centric approach. At investigators’ discretion, registered nurses and technology can be used in off-site facilities such as nursing home for subject recruitment, monitoring, and sample collection;
- •4. Subjects are willing to provide signed study-specific informed consent.
- •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 630
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1470
排除标准
- •1. Subjects received seasonal influenza vaccine within 6 months prior to study vaccination;
- •2. Clinically or virologically confirmed influenza infection within 6 months preceding the study start;
- •3. Any known or suspected allergy to any constituent of influenza vaccines (including but not limited to egg proteins) or a history of severe adverse reaction to a previous influenza vaccine;
- •4. Personal or family history of Guillain-Barré Syndrome;
- •5. Diagnosed coagulant function abnormality (e.g. clotting factor deficiency, clotting hemorrhagic disease, abnormal platelet function);
- •6. An acute febrile illness within 1 week prior to vaccination;
- •7. Subjects with influenza-like illness as defined by the presence of fever (temperature = 38.0°C).
- •8. Female subjects who are pregnant, lactating or likely to become pregnant during the study; also women of childbearing potential who disagree to use an acceptable method of contraception (e.g. hormonal contraceptives, IUD, barrier device or abstinence) throughout the study;
- •9. Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports;
- •10. Treatment with an investigational drug or device within 3 months prior to study vaccination;
- •11. Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection;
- •12. Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to = 20 mg/day of prednisone or equivalent for persons for > 2 weeks. Inhaled and topical steroids are allowed;
- •13. Receipt of live virus vaccine (both licensed and investigated) within 1 month prior to study vaccine or expected receipt within 1 month after study vaccination; receipt of any inactivated vaccine (both licensed and investigated) within 2 weeks prior to study vaccination or expected receipt within 1 month after study vaccination;
- •14. Receipt of any blood products, including immunoglobulin, within 3 months prior to study vaccination, which might interfere with assessment of the immune response;
- •15. Underlying condition which in the investigators’ opinion may interfere with evaluation of the study vaccine or prevents the subject from participating in the study.
研究者
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