Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
研究概览
简要总结
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.
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
- 2 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants aged ≥2 and <43 months at the first vaccination of the study drug (recommended: ≥2 and <7 months)
- •Written informed consent is obtained from a legal guardian (parent)
排除标准
- •Possibility of anaphylaxis due to food or pharmaceuticals
- •With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
- •With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
- •Participated in other studies within 12 weeks before obtaining consent
- •Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment
- •Additional screening criteria check may apply for qualification.
研究组 & 干预措施
BK1310
干预措施: DPT-IPV-Hib (Biological)
ActHIB® and Tetrabik
干预措施: Hib vaccine (Biological)
ActHIB® and Tetrabik
干预措施: DPT-IPV (Biological)
结局指标
主要结局
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
时间窗: 4 weeks after the primary immunization (Visit 4)
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8
次要结局
- Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody(4 weeks after the booster dose (Visit 6))
- Geometric Mean Antibody Titer of Anti-PRP Antibody(4 weeks after the booster dose (Visit 6))
- Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody(4 weeks after the booster dose (Visit 6))
- Geometric Mean Antibody Titer Against Diphtheria Toxin(4 weeks after the booster dose (Visit 6))
- Geometric Mean Antibody Titer Against Pertussis(4 weeks after the booster dose (Visit 6))
- Geometric Mean Antibody Titer Against Tetanus Toxin(4 weeks after the booster dose (Visit 6))
- Geometric Mean Antibody Titer Against Polio Virus(4 weeks after the primary immunization (Visit 4))
- Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus(4 weeks after the booster dose (Visit 6))
- Fold Change in Geometric Mean Antibody Titer Against Polio Virus(Baseline and 4 weeks after the primary immunization (Visit 6))
- Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody(4weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer of Anti-PRP Antibody(4weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer Against Diphtheria Toxin(4 weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer Against Pertussis(4 weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer Against Tetanus Toxin(4 weeks after the primary immunization (Visit 4))