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
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.
研究组 & 干预措施
Adjuvant-Free MenAC-Hib Conjugate Vaccine Group
Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine.
干预措施: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free) (Biological)
Adjuvant MenAC-Hib Conjugate Vaccine Group
Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.
干预措施: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant) (Biological)
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
- Occurrence of severe adverse events within six months post-vaccination(six months post-vaccination)
- 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)