NCT01268787已完成1 期
A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers
National Health Research Institutes, Taiwan4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Primary endpoint
研究概览
简要总结
This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers
详细描述
This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject who is free of obvious health problems
- •Able and willing to comply with the study procedure adn give written informed consent
排除标准
- •Female who is pregnant/lactating or planning to be pregnant
- •Body mass index(BMI) > 35
- •Oral temperature > 37.5 Celsius at the time of planned vaccination
- •Subject with any abnormal laboratory results at screening
- •With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
- •Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder
- •With a history of hypersensitivity to vaccine or allergic disease
- •Use of any investigational/non-registered product within 30 days prior to vaccination
- •Use of immunoglobulins or any blood products within 3 months prior to vaccination
- •Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination
结局指标
主要结局
Primary endpoint
时间窗: 210 Days
The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
1 期
To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy AdultsCoronavirus Disease (COVID-19)NCT04885361OSE Immunotherapeutics48
已完成
4 期
Phase IV Clinical Trial, Immunogenicity and Safety of EV71 VaccineHand, Foot and Mouth DiseaseNCT03278132Sinovac Biotech Co., Ltd120
已完成
1 期
Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and AdolescentsCovid19NCT04954287CyanVac LLC72
已完成
1 期
Safety, Tolerability, and Immunogenicity of ALFQ in a HIV Vaccine Containing A244 and B.65321 in Healthy AdultsHuman Immunodeficiency Virus (HIV)AIDS VirusNCT05423418U.S. Army Medical Research and Development Command65
终止
1 期
A Phase I Safety and Immunogenicity Preventive Vaccine Trial Based on the HIV-1 Tat and V2-deleted Env Proteins (ISS P-002)HIV InfectionNCT01441193Barbara Ensoli, MD11