NCT00530660已完成2 期
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)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20)
研究概览
简要总结
The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who participated in Study 810501 will be eligible for participation in the study if they:
- •Completed 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
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
结局指标
主要结局
Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20)
时间窗: 9 months
次要结局
未报告次要终点
研究者
研究点 (2)
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