A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 6
- 主要终点
- Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
研究概览
简要总结
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
- •For children < 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.
排除标准
- •Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.
结局指标
主要结局
Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
时间窗: Before and 21 days after the first vaccination
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
时间窗: 21 days after the second vaccination
Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
时间窗: Before and 21 days after the first vaccination
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
HI Antibody Titre Seroconversion Rate After the Second Vaccination
时间窗: Before and 21 days after the second vaccination
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
GMFI in the HI Antibody Titre After the Second Vaccination
时间窗: Before and 21 days after the second vaccination
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
时间窗: 21 days after the first vaccination
次要结局
- Duration of Solicited AEs After the Second Vaccination(During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.)
- Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination(During the 7 days after each vaccination)
- Duration of Solicited AEs After the First Vaccination(During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.)
- Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)(Up to 180 days after the last vaccination)
- Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination(During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs)