A Phase II, Single-centre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's Monovalent H1N1 Influenza Virus Vaccine in Healthy Adults Aged 18 to < 65 Years.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
研究概览
简要总结
The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged >= 18 to < 65 years at the time of providing informed consent.
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.
研究组 & 干预措施
CSL425 (30 mcg)
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
干预措施: CSL425 (Biological)
CSL425 (15 mcg)
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
干预措施: CSL425 (Biological)
结局指标
主要结局
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
时间窗: 21 days after the first vaccination
GMFI in the HI and MN Antibody Titer After the Second Vaccination
时间窗: Before and 21 days after the second vaccination
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
时间窗: Before and 21 days after the second vaccination
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
时间窗: Before and 21 days after the first vaccination
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
时间窗: Before and 21 days after the first vaccination
GMFI in 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 or MN Antibody Titre of 1:40 or More After the Second Vaccination
时间窗: 21 days after the second vaccination
次要结局
- Duration of Solicited Systemic AEs After the First Vaccination(From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7)
- HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group(Before and 21 days after the second vaccination)
- Duration of Solicited Local AEs After the Second Vaccination(From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7)
- Frequency and Intensity of Solicited Systemic AEs After the First Vaccination(From Day 0 to Day 6 after the first vaccination)
- Duration of Solicited Local AEs After the First Vaccination(From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7)
- Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group(21 days after the second vaccination)
- GMFI in the HI Antibody Titre 180 Days After the Second Vaccination(21 days and 180 days after the second vaccination)
- Frequency and Intensity of Unsolicited AEs(From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs)
- GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group(Before and 21 days after the first vaccination)
- GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group(Before and 21 days after the second vaccination)
- Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group(21 days after the first vaccination)
- Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination(Before and 21 days after each vaccination)
- Duration of Solicited Systemic AEs After the Second Vaccination(From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7)
- HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group(Before and 21 days after the first vaccination)
- Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination(180 days after the second vaccination)
- Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination(From Day 0 to Day 6 after the first vaccination)
- 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)
- Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination(Before and 21 days after each vaccination)
- Frequency and Intensity of Solicited Local AEs After the Second Vaccination(From Day 0 to Day 6 after the second vaccination)
- Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination(From Day 0 to Day 6 after the second vaccination)