A Randomized, Positive-controlled, Non-inferiority Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine in Healthy Infants and Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,992
- 主要终点
- Number of Participants With Solicited Adverse Reactions
研究概览
简要总结
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical trial is planned to conduct in healthy infants and children in China.
详细描述
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a randomized, positive-controlled, non-inferiority phase III clinical trial is planned to conduct in healthy infants and children in China.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 3-5 months/ 6-11 months/ 1-5 y for each age group
- •Without vaccination history of Hib conjugate vaccine
- •One of his/her guardians is able to understand and sign the informed consent
- •Subjects' guardian can and will comply with the requirements of the protocol
- •Subjects with temperature <=37.0°C on axillary setting
排除标准
- •Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- •Subject who is allergic to any ingredient of the vaccines
- •Subject with damaged or low immune function which has already been known
- •Subject who had a Hib disease medical history
- •Subject with acute febrile illness or infectious disease
- •Major congenital defects, developmental disorders or serious chronic illness
- •Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
- •Subject who has serious allergic history
- •Subject with other medical history not suitable for vaccination such as difficulty for blood collection
- •Any prior administration of immunodepressant or corticosteroids in last 6 months
- •Any prior administration of blood products in last 3 months
- •Any prior administration of other research medicine/vaccine in last 30 days
- •Any prior administration of any attenuated live vaccine in last 14 days
- •Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine
- •Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or his/her guardian's signature on informed consent
研究组 & 干预措施
Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)
Hib conjugate vaccine
干预措施: Hib conjugate vaccine (Biological)
Vaccine (Walvax Biotechnology Co., LTD.)
Hib conjugate vaccine
干预措施: Hib conjugate vaccine (Biological)
结局指标
主要结局
Number of Participants With Solicited Adverse Reactions
时间窗: 0-7 days after each dose
Number of Participants with Solicited Adverse Reactions
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml
时间窗: 28 days after full course of vaccination
次要结局
- the Anti-PRP Geometric Mean Concentrations (GMCs)(28 days after full course of vaccination)
- the Anti-PRP Geometric Mean Fold Increase (GMFI)(28 days after full course of vaccination)
- Incidence of Unsolicited Adverse Reactions(0-28 days after each dose)
- Incidence of Serious Adverse Event (SAE) During the Whole Study Period(0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y)
- Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml(28 days after full course of vaccination)