EUCTR2007-002894-30-AT进行中（未招募）不适用
AN OPEN-LABEL PHASE II STUDY TO ASSESS THE IMMUNOGENICITY AND SAFETY OF A BOOSTER VACCINATION WITH A HETEROLOGOUS VERO CELL-DERIVED WHOLE VIRUS H5N1 INFLUENZA VACCINE IN A HEALTHY YOUNG ADULT POPULATION (FOLLOW UP TO STUDY 810501) - INACTIVATED A/H5N1/INDONESIA/05/2005 INFLUENZA VACCINE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Baxter AG
- 入组人数
- 141
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
- •Completed through the Day 42 visit in study 810501
- •Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- •Are clinically healthy, as determined by the Investigator’s clinical judgment through collection of medical history and performance of a physical examination
- •Agree to keep a daily record of symptoms for the duration of the study
- •If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Have a history of vaccination with an H5N1 influenza virus since the second vaccination in study 810501
- •Have had an allergic reaction to one of the components of the vaccine since the second vaccination in Study 810501
- •Have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in Study 810501
- •Are unable to lead an independent life as a result of either physical or mental handicap
- •Suffer from any kind of immunodeficiency since the second vaccination in Study 810501
- •Suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
- •Have had severe allergic reactions or anaphylaxis since the second vaccination in Study 810501
- •Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
- •Have undergone systemic corticoid therapy within 30 days prior to study entry
- •Have a functional or surgical asplenia
- •Have a known or suspected problem with alcohol or drug abuse
- •Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
- •Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator
- •If female: are pregnant or lactating
研究者
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