NCT00735475已完成4 期
A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years
Seqirus26 个研究点 分布在 1 个国家目标入组 1,268 人开始时间: 2008年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,268
- 试验地点
- 26
- 主要终点
- Geometric Mean Titer 21 Days After the Study Vaccination
研究概览
简要总结
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.
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
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
- •Written informed consent ;
- •Willingness to provide a blood sample.
排除标准
- •Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
- •Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
- •Known history of Guillain-Barré Syndrome;
- •Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
- •Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
- •History of seizures;
- •Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
- •Clinically significant history of malignancy
- •Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
- •Current immunosuppressive or immunomodulative therapy;
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
- •Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
- •Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
- •Current treatment with warfarin or other anticoagulants;
- •Major congenital defects;
- •Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
- •Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
- •History of psychiatric disorders;
- •Resident of long term care facility.
研究组 & 干预措施
Afluria®
Experimental
干预措施: CSL Limited Influenza Virus Vaccine (Afluria®) (Biological)
Fluzone®
Active Comparator
干预措施: US Licensed Influenza Virus Vaccine (Fluzone®) (Biological)
结局指标
主要结局
Geometric Mean Titer 21 Days After the Study Vaccination
时间窗: 21 days after vaccination
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination
时间窗: 21 days after vaccination
Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
次要结局
- Frequency and Intensity of Unsolicited Adverse Events (UAEs)(21 days after vaccination)
- Serious Adverse Events(180 days after vaccination)
- Duration of Local and Systemic Solicited Symptoms(5 days after vaccination)
- Frequency and Intensity of Local and Systemic Solicited Symptoms(5 days after vaccination)
- New Onsets of Chronic Illness(180 days after vaccination)
研究者
研究点 (26)
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