NCT02140047已完成2 期
Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, 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 efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control 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 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants aged ≥2 and <7 months at the first vaccination of the study drug
- •Written informed consent is obtained from a legal guardian (parent)
排除标准
- •With obvious pyrexia (axillary temperature of 37.5ºC or higher) at vaccination of the study drug
- •With known serious acute disease
- •With known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, and respiratory disease
- •With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
- •History of anaphylaxis due to food or pharmaceuticals
- •With experience of Hib infection, diphtheria, pertussis, tetanus, and acute poliomyelitis
- •With experience of Hib vaccination, or administration of vaccine including either diphtheria, pertussis, tetanus, or polio as a constituent
- •History of convulsions
- •Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination
- •Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
- •Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) continuously for more than 1 week
- •Participated in other studies within 12 weeks before obtaining consent
研究组 & 干预措施
MT-2301-Low
Experimental
干预措施: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV (Biological)
ActHIB
Active Comparator
干预措施: Haemophilus influenza type b conjugate vaccine + DPT-IPV (Biological)
MT-2301-High
Experimental
干预措施: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV (Biological)
结局指标
主要结局
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
时间窗: 4 weeks after the primary immunization (Visit 4)
次要结局
- Geometric Mean Antibody Titer Against Pertussis(4 weeks after the booster dose (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(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 Tetanus Toxin(4 weeks after the booster dose (Visit 6))
- Fold Change in Geometric Mean Antibody Titer Against Polio Virus(4 weeks after the booster dose (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(4 weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer of Anti-PRP Antibody(4 weeks 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))
- Fold Change in Geometric Mean Antibody Titer Against Polio Virus(4 weeks after the primary immunization (Visit 4))
研究者
研究点 (1)
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