Randomized, Double-Blind, Active-Controlled Study in Adults to Assess the Safety and Immunogenicity of Abbott’s Candidate Quadrivalent Influenza Vaccine and its Non-Inferiority to Trivalent Influenza Vaccine.

Abbott Biologicals B.V.0 个研究点目标入组 1,980 人开始时间: 2015年1月20日最近更新: 2016年5月2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: 1,980

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. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
•2. Men and women aged = 18 years of age at the day of study vaccination.
•3. Being in good health as judged by medical history, physical examination and clinical judgment of the Investigator (subjects may have underlying chronic illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If on regular prescribed medication for a condition, the medication dose must have been stable for at least three 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 1140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 840

排除标准

•1. History of allergy to egg, chicken proteins, or other vaccine components.
•2. History of serious adverse reaction to any influenza vaccine.
•3. History of Guillain-Barré syndrome.
•4. Confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment.
•5. Receipt of any vaccine within the preceding 4 weeks prior to study vaccination or planned vaccination during the study between Visit 1 (Day 1) and Visit 2 (Day 22).
•6. Having fever and/or presenting with an acute disease or infection on the day of study vaccination. Fever is defined as an oral temperature of = 38.0 ºC.
•7. Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding study vaccination.
•8. Using or having used medication that influences the immune system (such as corticosteroids and monoclonal antibodies) during the four weeks prior to the study or planned use thereof during the study. Topical use of corticosteroids (i.e., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed.
•9. Receipt of blood or blood products within the 3 months preceding enrollment.
•10. Participation in a placebo-controlled influenza vaccine clinical trial any time prior to entering this study if the treatment arm is not known.
•11. Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the study vaccine including (but not limited to) bleeding disorder, known immunodeficiency, seizure disorder, acute, severe or progressive hepatic, renal, neurological or neuromuscular disease.
•12. Being a solid organ or bone marrow/stem cell transplant recipient.
•13. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months before the day of study vaccination.

研究者

发起方

Abbott Biologicals B.V.

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