A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged ≥ 18 to < 60 Years) and 'Older Adults' (Aged ≥ 60 Years).
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 a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.
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 at the time of providing informed consent
- •Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
- •Willing and able to adhere to all protocol requirements
- •Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
- •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
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 Enzira® vaccine
- •Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
- •A clinically significant medical or psychiatric condition
- •A confirmed or suspected immunosuppressive condition
- •History of seizures
- •History of Guillain-Barré Syndrome
- •Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry
- •Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine
- •Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry
- •Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of Enzira® vaccine
- •Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine
- •Currently receiving treatment with warfarin or other anticoagulants
- •Evidence or history of substance or alcohol abuse within the 12 months before study entry
- •Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period
- •Females who are pregnant or lactating
- •Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation
研究组 & 干预措施
Adults
Healthy volunteers aged 18 to 59 years
干预措施: Inactivated Influenza Vaccine (2009 / 2010 formulation) (Biological)
Older Adults
Healthy volunteers aged 60 years or older
干预措施: Inactivated Influenza Vaccine (2009 / 2010 formulation) (Biological)
结局指标
主要结局
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 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 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
- The Incidence of Any Unsolicited Adverse Events (AEs).(After vaccination until the end of the study; approximately 21 days)
- The Frequency of Any Solicited Systemic Symptoms.(During the 4 days after vaccination (Day 0 plus 3 days))
- The Frequency of Any Solicited Local Reactions.(During the 4 days after vaccination (Day 0 plus 3 days))