NCT00519389已完成1 期
A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novavax
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Safety and reactogenicity of H5N1 VLP Vaccine
研究概览
简要总结
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 to 40 years of age at the time of the vaccination.
- •Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).
- •Available by telephone.
- •Free of obvious health problems as established by medical history and clinical examination before entering the study.
- •If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
- •Must provide written, informed consent.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- •Has received any other licensed vaccines within 4 weeks prior to enrollment in this study.
- •Has received any influenza vaccine within the prior 12 month period.
- •Has received any investigational vaccine designed for protection against avian influenza.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
- •Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
- •Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º F.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.
结局指标
主要结局
Safety and reactogenicity of H5N1 VLP Vaccine
时间窗: 6 months
次要结局
- Immunogenicity of H5N1 VLP Influenza vaccine(6 months)
研究者
研究点 (2)
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