NCT03865238已完成3 期
A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled, Multi-region Study to Evaluate the Efficacy, Safety, and Immunogenicity of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant in Infants and Children
Medigen Vaccine Biologics Corp.6 个研究点 分布在 2 个国家目标入组 3,061 人开始时间: 2019年4月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,061
- 试验地点
- 6
- 主要终点
- Number of Laboratory Confirmed EV71-Associated Disease
研究概览
简要总结
Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. A booster vaccine will be given 365 days after the first dose in subjects 2 months to < 2 years of age. The last study visit is on Day 422 when subjects will be contacted via telephone / home visit system to assess for adverse events and concomitant medications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children and infants aged from 2 months to less than 6 years as established by medical history and clinical examination.
- •The subjects' parents/guardians are able to understand and sign the ICF.
排除标准
- •Age < 2 months or ≥ 6 years.
- •For subjects < 1 year, gestational age < 34 weeks or birth weight < 2200 grams.
- •Has poor venous access (for subjects in sub-study only).
- •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 previous known exposure to EV71 or has received EV71 vaccine.
- •Has a history of herpangina or HFMD associated with enterovirus infection in the past 30 days before the date of the 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 of the vaccine.
- •Has used any investigational/non-registered product (including drug, vaccine, or invasive medical device) within 28 days before vaccination or plan to use during the study period.
- •Has confirmed or suspected autoimmune disorder, or immunodeficiency.
- •Administration of any licensed live attenuated vaccine within 14 days before or after each study vaccination (with the exceptions of live attenuated Rotavirus vaccine via oral route).
- •Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period.
- •Has had immunosuppressants, cytotoxic drugs, corticosteroids (including prednisolone ≥ 0.5 mg/kg/day or equivalent), or immunomodulators taken for > 14 days within 6 months before first vaccination or plan to use before the last scheduled study visit. (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.
结局指标
主要结局
Number of Laboratory Confirmed EV71-Associated Disease
时间窗: Approximately 14 months
The primary outcome is the number of Laboratory confirmed EV71-associated disease by viral isolation or CODEHOP assay.
次要结局
未报告次要终点
研究者
研究点 (6)
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