A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2010/2011 Formulation of Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
研究概览
简要总结
The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18 years and older at the time of the first study vaccination.
排除标准
- •Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
- •Clinical signs of an active infection
- •Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry
- •Females who are pregnant or lactating
研究组 & 干预措施
Adults
Healthy volunteers aged 18 to 59 years
干预措施: CSL's 2010/2011 Formulation of Enzira® Vaccine (Biological)
Older Adults
Healthy volunteers aged 60 years or older
干预措施: CSL's 2010/2011 Formulation of Enzira® Vaccine (Biological)
结局指标
主要结局
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
时间窗: Approximately 21 days after vaccination
As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
时间窗: Approximately 21 days after vaccination
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
时间窗: Approximately 21 days after vaccination
GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.
次要结局
- Frequency of Any Solicited Adverse Events (AEs)(During the 4 days after vaccination (Day 0 plus 3 days))
- Frequency and Intensity of Any Unsolicited Adverse Events(After vaccination until the end of the study; approximately 21 days)