NCT00617851已完成3 期
A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years
Novartis Vaccines2 个研究点 分布在 1 个国家目标入组 1,507 人开始时间: 2007年11月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,507
- 试验地点
- 2
- 主要终点
- Geometric Mean Titers (GMTs), by Vaccine Lots
研究概览
简要总结
The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 49 years of age;
- •In good health as determined by medical history and physical examination;
- •Able and willing to provide written informed consent prior to any study procedure;
- •Able to comply with all study procedures and available for all clinic visits scheduled in the study.
排除标准
- •Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
- •History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
- •Known or suspected impairment/alteration of immune function
- •Receipt of an influenza vaccine within 6 months prior to Visit 1;
- •Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
- •Laboratory-confirmed influenza disease within 6 months prior to Visit 1
结局指标
主要结局
Geometric Mean Titers (GMTs), by Vaccine Lots
时间窗: 21 days after vaccination
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
次要结局
- Number of Subjects With at Least One Unsolicited Adverse Event(3 weeks after vaccination)
- Geometric Mean Titers (GMTs), by Vaccine Group and Strain(21 days after vaccination)
- Number of Subjects Reporting Solicited Local and Systemic Symptoms(7 days after vaccination)
- Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)(21 days after vaccination)
- Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)(21 days after vaccination)
- Percentage of Subjects With Seroprotection and Seroconversion (Strain B)(21 days after vaccination)
研究者
研究点 (2)
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