NCT02919293Unknown1 期
Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
研究概览
简要总结
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.
Primary objective:
- To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
- To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to that of adjuvant MenAC-Hib conjugate vaccine.
Secondary objective:
•To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health infants aged 2 to 5 months.
- •Legal guardian has signed written informed consent.
- •Guardian may finish the whole visit in the judgment of investigator.
- •2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine.
- •Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.
排除标准
- •Fever, body temperature ≥37.1℃.
- •History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine.
- •Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection.
- •Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease.
- •Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection.
- •Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease.
- •Subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°C) within 3 days.
- •Any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial.
结局指标
主要结局
Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
时间窗: Day 30 post-vaccination
Occurrence of adverse events during a 30 day follow-up period after each vaccination
时间窗: 30 day after each vaccination
次要结局
- Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine(Day 30 post-vaccination)
- Occurrence of severe adverse events within six months post-vaccination(six months post-vaccination)
研究者
研究点 (1)
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