NL-OMON35419已完成3 期
An Open-Label Phase III Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as well as in Specified Risk Groups - H5N1 Influenza Vaccine - 810705
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Baxter
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Are 18 years of age or older
- •-Agree to keep a daily record of symptoms for the duration of the study
- •-Are generally healthy, as determined by the investigator*s clinical judgment
- •through collection of medical history and performance of a physical
- •examination.
排除标准
- •-Have a history of exposure to H5N1 virus or a history of vaccination with an
- •H5N1 influenza vaccine;
- •-Are at high risk of contracting H5N1 influenza infection
- •-Have a history of severe allergic reactions or anaphylaxis;
- •-Have a rash, dermatological condition or tattoos which may interfere with
- •injection site reaction rating;
- •-Have received any live vaccine within 4 weeks or inactivated vaccine within 2
- •weeks prior to vaccination in this study;
- •-Currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder.
研究者
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