A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2013/2014 Formulation of the 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
- 2
- 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
This is a study to assess the immune (antibody) response and safety of the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.
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
- •Males or females aged 18 years or older at the time of vaccination.
- •Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.
排除标准
- •Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
- •Clinical signs of an active infection.
- •A clinically significant medical condition.
- •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 (aged 18 to 59 years)
The study vaccine (Enzira® vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection.
干预措施: Enzira® vaccine (Biological)
Older Adults (aged 60 years or older)
The study vaccine (Enzira® vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection.
干预措施: 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 (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10. A significant increase (H1N1, H3N2, and B influenza virus strains) 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
For the H1N1, H3N2 and B influenza virus strains. Note: No SRH data were collected.
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
时间窗: Approximately 21 days after vaccination
GMFI (H1N1, H3N2, and B influenza virus strains) 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 of Any Unsolicited AEs(After vaccination until the end of the study; approximately 21 days.)