A Randomized, Double-Blind, Multicenter, Parallel-Group Comparative Phase III Study Evaluating the Efficacy and Safety of TAK-816 Compared With ActHIB in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 416
- 试验地点
- 22
- 主要终点
- Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 ϻg/mL
研究概览
简要总结
The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when administered to healthy Japanese infants as multiple subcutaneous doses.
详细描述
Haemophilus Influenzae type b (Hib) is one of the major causes of infectious meningitis in children, and can also cause sepsis, cellulitis, arthritis, epiglottitis, pneumonia and myelitis.
TAK-816 is a conjugated Hib vaccine being tested in healthy infants aged 3-6 months at the time of the first dose.
The objective of this study is to evaluate the efficacy (immunogenicity) and safety of TAK-816 (10 ϻg/0.5 mL) in comparison with ActHIB (Haemophilus b Conjugate Vaccine) as a control.
In addition, the efficacy (immunogenicity) and safety of Absorbed Diphtheria-Purified Pertussis-Tetanus Combined (DPT-TAKEDA) vaccine when TAK-816 and DPT vaccine are administered concomitantly will also be investigated.
For the Primary Immunization Phase of this study: three doses of TAK-816 or ActHIB 10 µg/0.5 mL and DPT-TAKEDA 0.5 mL will be administered at 4-week intervals over 8 weeks (Visit 1, 2, 3). At4 weeks after the third dose, a follow-up observation and evaluation will be made (Visit 4).
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
- 3 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female infants aged ≥3 and <7 months (excluding hospitalized infants).
- •Infants whose legal acceptable representatives have given informed consent to the study prior to enrollment.
- •Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
排除标准
- •Any serious acute illness.
- •Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
- •History of possible Haemophilus influenzae type b (Hib) infection.
- •History of possible pertussis, diphtheria or tetanus infection.
- •Previously diagnosed immunodeficiency.
- •A documented history of anaphylaxis to any ingredient of the investigational products (TAK-816, ActHIB or DPT-TAKEDA).
- •A history of convulsions.
- •Previous administration of another Hib vaccine.
- •Previous administration of any other vaccine containing any of the components of polio, diphtheria, pertussis, or tetanus.
- •Treatment with any live vaccine during the 27 days before the first dose of TAK-816 or with any inactivated vaccine during the 6 days before dosing.
研究组 & 干预措施
TAK-816
干预措施: TAK-816+ DPT-TAKEDA (Biological)
ActHIB
干预措施: ActHIB+ DPT-TAKEDA (Biological)
结局指标
主要结局
Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 ϻg/mL
时间窗: 4 weeks after the third dose (Visit 4)
次要结局
- Proportion of participants with an anti-PT GMT(4 weeks after the single booster dose (Visit 6))
- Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥0.15 ϻg/mL(4 weeks after the third dose (Visit 4))
- Proportion of participants with an anti-PRP geometric mean titers (GMT)(4 weeks after the third dose (Visit 4))
- Proportion of participants with an anti-pertussis toxin (PT) titer ≥10 EU/mL(4 weeks after the third dose (Visit 4))
- Proportion of participants with an anti-PRP titer ≥1 ϻg/mL(4 weeks after the single booster dose. (Visit 6))
- Proportion of participants with an anti-PRP GMT(4 weeks after the single booster dose. (Visit 6))
- Proportion of participants with an anti-PRP titer ≥0.15 ϻg/mL(4 weeks after the single booster dose. (Visit 6))
- Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL(4 weeks after the single booster dose (Visit 6))
- Proportion of participants with an anti-diphtheria toxoid GMT(4 weeks after the single booster dose (Visit 6))
- Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL(4 weeks after the single booster dose (Visit 6))
- Proportion of participants with an anti-PT titer ≥10 EU/mL(4 weeks after the single booster dose (Visit 6))
- Proportion of participants with an anti-filamentous hemagglutinin (FHA) titer ≥10 EU/mL(4 weeks after the third dose (Visit 4))
- Proportion of participants with an anti-FHA GMT(4 weeks after the single booster dose (Visit 6))
- Proportion of participants with an anti-FHA titer ≥10 EU/mL(4 weeks after the single booster dose (Visit 6))
- Proportion of participants with an anti-tetanus toxoid GMT(4 weeks after the single booster dose (Visit 6))