A Study to Evaluate Immunogenicity and Safety of Boostrix When Co-administered With Fluarix in Subjects 19 Years of Age and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,726
- 试验地点
- 12
- 主要终点
- Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
研究概览
简要总结
The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.
排除标准
- •Administration of an influenza vaccine within six months prior to study entry
- •Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
- •Administration of a Tdap vaccine at any time prior to study entry.
- •Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
- •History of diphtheria and/or tetanus and/or pertussis disease.
- •History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.
研究组 & 干预措施
BOOSTRIX+FLUARIX GROUP
Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
干预措施: Fluarix® (Biological)
FLUARIX BOOSTRIX GROUP
Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
干预措施: Fluarix® (Biological)
FLUARIX BOOSTRIX GROUP
Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
干预措施: Boostrix® (Biological)
BOOSTRIX+FLUARIX GROUP
Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
干预措施: Boostrix® (Biological)
结局指标
主要结局
Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
时间窗: At Month 1 post-Boostrix® vaccination
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza
时间窗: At Month 1 post-Fluarix® vaccination
The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens
时间窗: At Month 1 post-Boostrix® vaccination
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively.
Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value
时间窗: At Month 1 post-Boostrix® vaccination
The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).
Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B
时间窗: At Month 1 post-Fluarix® vaccination
Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer.
次要结局
- Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN)(At Day 0 and Month 1 post-Boostrix® vaccination)
- Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens(At Month 1 post-Boostrix® vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the whole study period (from Day 0 to Month 2))
- Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value(At Month 1 post-Boostrix® vaccination)
- Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T)(At Day 0 and Month 1 post-Boostrix® vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day period (Day 0-30) following each vaccination, up to 2 months)
- Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens(At Month 1 post-Boostrix® vaccination)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months)
- Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers(At Month 1 post-Fluarix® vaccination)