A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- The GMT of anti-EV71 antibodies in serum after first vaccination
研究概览
简要总结
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.
The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase I study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. In order to provide more evidence for the immunogenicity of the vaccine, to further explore the probable immunizing dose and the safety profile of this vaccine, a phase II clinical trial is planed to conduct.
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
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For children group (aged from 12-36 months):
- •Healthy children aged from 12 to 36 months old as established by medical history and clinical examination
- •The subjects' guardians are able to understand and sign the informed consent
- •Had never received the vaccine against EV71
- •Subjects who can and will comply with the requirements of the protocol
- •Subjects with temperature <=37.0°C on axillary setting
- •For infants group (aged from 6-11 months):
- •Healthy infants aged from 6 to 11 months old as established by medical history and clinical examination
- •The subjects' guardians are able to understand and sign the informed consent
- •Had never received the vaccine against EV71
- •Subjects who can and will comply with the requirements of the protocol
- •Subjects with temperature <=37.0°C on axillary setting
排除标准
- •For children group (aged from 12-36 months):
- •Subject who has a medical history of HFMD
- •<= 37 weeks gestation
- •Subjects with a birth weight <2.5 kg
- •Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- •Family history of seizures or progressive neurological disease
- •Family history of congenital or hereditary immunodeficiency
- •Severe malnutrition or dysgenopathy
- •Major congenital defects or serious chronic illness, including perinatal brain damage
- •Autoimmune disease
- •Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- •Any acute infections in last 7 days
- •Any prior administration of immunodepressant or corticosteroids in last 6month
- •Any prior administration of blood products in last 3 month
- •Any prior administration of other research medicines in last 1 month
- •Any prior administration of attenuated live vaccine in last 28 days
- •Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- •Under the anti-TB prevention or therapy
- •Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- •For infants group (aged from 6-11 months):
- •Subject who has a medical history of HFMD
- •<= 37 weeks gestation
- •Subjects with a birth weight <2.5 kg
- •Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- •Family history of seizures or progressive neurological disease
- •Family history of congenital or hereditary immunodeficiency
- •Severe malnutrition or dysgenopathy
- •Major congenital defects or serious chronic illness, including perinatal brain damage
- •Autoimmune disease
- •Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- •Any acute infections in last 7 days
- •Any prior administration of immunodepressant or corticosteroids in last 6month
- •Any prior administration of blood products in last 3 month
- •Any prior administration of other research medicines in last 1 month
- •Any prior administration of attenuated live vaccine in last 28 days
- •Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- •Under the anti-TB prevention or therapy
- •Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- •Exclusion Criteria for the second dose:
- •Had any Grade 3 or Grade 4 adverse reaction within 7 days after first dose
- •Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
- •Had any SAE related to first dose during the following-up of first dose
- •Any condition that in the opinion of the investigator, or IRB
结局指标
主要结局
The GMT of anti-EV71 antibodies in serum after first vaccination
时间窗: 28 days after first vaccination
to evaluate the GMT of anti-EV71 antibodies in serum 28 days after first vaccination
The GMT of anti-EV71 antibodies in serum after second vaccination
时间窗: 28 days after second vaccination
to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination
Frequency of systemic and local adverse reactions after the first vaccination
时间窗: 28 days after the first vaccination
Frequency of systemic and local adverse reactions in healthy Children and infants following first doses of EV71 vaccine
Frequency of systemic and local adverse reactions after the second vaccination
时间窗: 28 days after the second vaccination
Frequency of systemic and local adverse reactions in healthy Children and infants following second doses of EV71 vaccine
次要结局
- The seroconversion rate of anti-EV71 antibodies in serum after first vaccination(28 days after first vaccination)
- The seroconversion rate of anti-EV71 antibodies in serum after second vaccination(28 days after second vaccination)
- Frequency of adverse events and any SAE after the first vaccination(28 days after the first vaccination)
- Frequency of adverse events and any SAE after the second vaccination(28 days after the second vaccination)
- The clinical abnormality of hematological examination, blood biochemical test and urinalysis after first vaccination in children(3 days after first vaccination)
- The clinical abnormality of hematological examination, blood biochemical test and urinalysis after second vaccination in children(3 days after second vaccination)
- The persistence of immunogenicity of the EV71vaccine after two doses in children and infants(6 months after blood collection at day 56)