A Phase III, Open, Randomized, Multicenter, Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 11
- 主要终点
- Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
研究概览
简要总结
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
时间窗: At Day 10 post Dose 1
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
时间窗: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
时间窗: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Seroconversion Factor for Influenza A Subtype H9N2
时间窗: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.
Number of Seroprotected Subjects Against H9N2
时间窗: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Number of Subjects With Seroprotection Power Against H9N2
时间窗: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
次要结局
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 30-days (Day 0-30) post vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 to Day 51)
- Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells(At Days 0, 10, 21 and 42 post vaccination)
- Frequency of Antigen-specific CD4 T-cells(At Days 0, 10, 21 and 42 post-vaccination)
- Cytokine-positive CD4 T-cells Frequency(At Days 10, 21 and 42 post-vaccination)
- Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells(At Days 0, 10, 21 and 42 post-vaccination)
- Frequency of Antigen-specific CD8 T-cells(At Days 0, 10, 21 and 42 post-vaccination)
- Cytokine-positive CD8 T-cells Frequency(At Days 10, 21 and 42 post-vaccination)
- Number of Subjects With Solicited Local Symptoms(During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups))
- Number of Subjects With Solicited General Symptoms(During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups))
- Number of Subjects With Unsolicited AEs(During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups))
- Number of Subjects With SAEs(Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups))
- Number of Subjects With Any SAEs(Up to 30-day post Dose 3 (Days 365-394))
- Number of Subjects With Antibody Persistence(At Days 189 and 365)
- Seroconversion Factor (SCF) for Influenza A Subtype H9N2.(At Days 189 and 365)