A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,893
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
研究概览
简要总结
This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.
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
- 3 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects 3 to 64 years of age
排除标准
- •Receipt of other investigational products within 3 months or other vacine within 1 month;
- •Allergy to eggs, egg products, or any other vaccine component;
- •Laboratory confirmed influenza disease within 6 months;
- •Have previously received an influenza vaccination (3 to 8 years only);
研究组 & 干预措施
Comparator influenza vaccine
干预措施: Comparator influenza vaccine (Biological)
Influenza virus vaccine
干预措施: Influenza virus vaccine (Biological)
结局指标
主要结局
Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
时间窗: 21 days after vaccination
To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
时间窗: 21 days after vaccination
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
次要结局
- Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age(7 days after vaccination)
- Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age(21 days after vaccination)
- Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age(21 days after vaccination)
- Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age(21 days after vaccination)
- Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age(7 days after vaccination)
- Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age(50 days after last vaccination)
- Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age(50 days after last vaccination)
- Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age(50 days after last vaccination)
- Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.(7 days after each vaccination)
- Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age(21 days after vaccination)