A Prospective, Open-label, Multi-center, Phase 3 Study to Evaluate the Immunogenicity and Safety of an Inactivated EV71 Enterovirus Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 378
- 试验地点
- 6
- 主要终点
- Immunogenicity of Envacgen®
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of EV71 vaccine (Envacgen®) in Children Aged 6 to <10 Years compared to Children Aged 2 to <6 Years.
详细描述
This is a prospective, open-label, multi-center, phase 3 study. Participants will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. The last study visit is on Day 237 when participants will be contacted via telephone to assess for adverse events .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 2 to <10 years as established by medical history and clinical examination.
- •Subject and/or the subject's parent/guardian is able to understand and sign the ICF.
排除标准
- •Has poor venous access.
- •Currently has a fever defined as ear/rectal temperature ≥ 38°C or axillary temperature ≥ 37.5 °C within 2 days before the time of planned vaccination.
- •Has had previously known exposure to EV71 or has received EV71 vaccine.
- •Has a history of herpangina or HFMD associated with enterovirus infection in the past 28 days before the date of planned study drug vaccination.
- •Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
- •Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component or any residual trace components such as formaldehyde of the Envacgen® vaccine.
- •Has used any investigational/nonregistered product (including drug, vaccine, or invasive medical device) within 28 days before study vaccination or plans to use any of them during the study period.
- •Has confirmed or suspected autoimmune disorder or immunodeficiency.
- •Has been administered or plans to be administered with any licensed live attenuated vaccine within 14 days before or after each study vaccination.
- •Has used immunoglobulins via intravenous route or any blood products within 11 months before vaccination or plans to use any of them during the study period.
- •Has received immunosuppressant, cytotoxic drug, corticosteroid (including prednisolone ≥ 0.5 mg/kg/day or equivalent), immunomodulator or acetylsalicylic acid for > 14 days within 6 months before the first vaccination or plans to use any of them during the study period. (Inhaled and topical steroids are allowed).
- •Has any medical or psychiatric condition that is a contraindication to protocol participation based on the judgment of the Investigator.
研究组 & 干预措施
Children Aged 6 to <10 Years
EV71 Vaccine (Envacgen®)
干预措施: Envacgen® (Biological)
Children Aged 2 to <6 Years
EV71 Vaccine (Envacgen®)
干预措施: Envacgen® (Biological)
结局指标
主要结局
Immunogenicity of Envacgen®
时间窗: Day 1 to 28 days after the second vaccination.
1. Geometric Mean Titer (GMT) of Neutralizing Antibody (NTAb) Measurement of NTAb titers against EV71 at 28 days after the second dose of Envacgen® in children aged 6 to \<10 years (Old group) compared with children aged 2 to \<6 years (Young group). 2. Seroresponse Rate (SRR) of Neutralizing Antibody (NTAb) Percentage of participants with seroresponse (defined as at least a four-fold increase from baseline in NTAb titers) at 28 days after the second dose of Envacgen® in children aged 6 to \<10 years (Old group) compared with children aged 2 to \<6 years (Young group).
Incidence of Adverse Events(AEs) [Safety]
时间窗: Day 1 to 28 days after the second vaccination.
Number and percentage of participants in the Old group (6 to \<10 years) and Young group (2 to \<6 years) with any reported adverse events within 28 days after vaccination with Envacgen®.
Incidence of Adverse Events(AEs) [Safety]
时间窗: Day 1 to 28 days after the second vaccination.
Number and percentage of participants in the Old group (6 to \<10 years) and Young group (2 to \<6 years) with any reported adverse events within 28 days after vaccination with Envacgen®.
Immunogenicity of Envacgen®
时间窗: Day 1 to 28 days after the second vaccination.
1. Geometric Mean Titer (GMT) of Neutralizing Antibody (NTAb) Measurement of NTAb titers against EV71 at 28 days after the second dose of Envacgen® in children aged 6 to \<10 years (Old group) compared with children aged 2 to \<6 years (Young group). 2. Seroresponse Rate (SRR) of Neutralizing Antibody (NTAb) Percentage of participants with seroresponse (defined as at least a four-fold increase from baseline in NTAb titers) at 28 days after the second dose of Envacgen® in children aged 6 to \<10 years (Old group) compared with children aged 2 to \<6 years (Young group).
次要结局
- Incidence of Adverse Events(AEs) [Safety](Day 1 to 180 days after the second vaccination.)
- Incidence of Adverse Events(AEs) [Safety](Day 1 to 180 days after the second vaccination.)