EUCTR2022-003455-33-Outside-EU/EEA进行中（未招募）1 期
A Double-Blind, Randomized, Placebo-Controlled, Age Descending and Expansion Phase 2 Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female at least 1.5 years and =45 years old at time of screening.
- •2. In good health as determined by medical history, physical examination including height and weight.
- •3. Normal safety laboratory values at screening.
- •4. Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen.
- •5. Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception.
- •6. Weight: Within 1.3 times of the upper limit of local normal age-adjusted body mass index (BMI).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 309
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 51
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. For participants =12 years, clinically significant electrocardiogram (ECG) findings.
- •2. History of significant dermatologic (skin) disease within last 6 months.
- •3. History of diabetes mellitus.
- •4. History of thymic pathology, thymectomy, myasthenia or any immunodeficiency.
- •5. History of recurring headaches or migraines.
- •6. Hypersensitivity to any vaccine.
- •7. For participants =12 years, positive urine screen for cocaine, amphetamines, opiates, or cannabinoids.
- •8. History of alcohol abuse.
- •9. Pregnant or lactating female.
研究者
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