Randomized, Double-Blind, Active-Controlled Trial to Assess the Safety and Immunogenicity of Solvay's Cell-Derived Influenza Vaccine, Including Revaccination, in Elderly subjects.

Abbott Biologicals B.V.0 个研究点目标入组 600 人开始时间: 2009年9月15日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Abbott Biologicals B.V.
入组人数: 600

研究概览入排标准研究者记录与标识符相似试验

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. Female or male subjects > 61 years of age.
•2. Willing and able to give informed consent before any protocol procedures are performed.
•3. Able to adhere to visit schedules and all protocol required study procedures.
•4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as
•hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been unchanged for at least 3 months preceding study vaccination).
•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. Seasonal influenza vaccination or laboratory confirmed seasonal influenza infection
•within six months preceding the date of study vaccination or planning an influenza
•vaccination (seasonal or novel Influenza A (H1N1)) within three weeks of study
•vaccination.
•2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
•3. A serious adverse reaction after a previous vaccination, including influenza vaccination.
•4. A history of Guillain-Barré syndrome.
•5. Known to be allergic to constituents of the study vaccines.
•6. Fever and/or presence of an acute infectious episode of the upper and/or lower respiratory airways. Fever is defined as an oral temperature of = 38ºC. Enrollment can be postponed until a subject has been a febrile for 72 hours.
•7. Being a solid organ or bone marrow/stem cell transplant recipient.
•8. Use of immune system modulators including: systemic corticosteroids,
•immunosuppressive agents such as cyclosporine, intravenous monoclonal antibodies and intravenous or intramuscular gamma-globulin preparations within four weeks of study vaccination or if planned for use any time during the study. Topical use of corticosteroids (e.g. cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the package insert, is allowed.
•9. Chronic diseases requiring long-term immunosuppressive therapy.
•10. Receipt of another investigational product within 90 days prior to entering this study (date of informed consent), participating in the long-term follow-up of another clinical trial, unwilling to refuse to participate in another clinical trial during the current clinical study.
•11. Known drug or alcohol abuse.
•12. Blood or plasma transfusions received within three months of study vaccination.
•13. Vaccination with a live vaccine or a killed/inactivated vaccine in the four weeks prior to study vaccination.
•14. Being an employee of the Sponsor/CRO conducting this study or personnel of the study site.
•15. During the second year of the study only: History of vaccination with a seasonal
•influenza vaccine following initial study vaccination on studies Day 1 (Visit 1).

研究者

发起方

Abbott Biologicals B.V.

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