A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 473
- 试验地点
- 13
- 主要终点
- Seroconversion Rate 21 Days After Second Study Vaccination
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
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 9 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 gestation.
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
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Biological)
CSL425 (7.5 mcg)
7.5 mcg of hemagglutinin antigen per dose
干预措施: CSL's 2009 H1N1 Influenza Vaccine (CSL425) (Biological)
CSL425 (15 mcg)
15 mcg of hemagglutinin antigen per dose
干预措施: CSL's 2009 H1N1 Influenza Vaccine (CSL425) (Biological)
结局指标
主要结局
Seroconversion Rate 21 Days After Second Study Vaccination
时间窗: 21 days after the second study vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Seroconversion Rate 21 Days After First Study Vaccination
时间窗: 21 days after the first study vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination
时间窗: 21 days after the first study vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination
时间窗: 21 days after the second study vaccination
次要结局
- Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A(During the 7 days after each study vaccination)
- Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination(During the 21 days after each vaccination)
- Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A(During the 7 days after each study vaccination)
- Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B(During the 7 days after each study vaccination)
- Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B(During the 7 days after each study vaccination)
- Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)(Up to 180 days after the last vaccination)