NCT00921947已完成1 期
A Phase II, Randomized, Open-Label Study to Evaluate the Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) in Healthy Adults
VaxInnate Corporation2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年6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
- 2
- 主要终点
- Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
研究概览
简要总结
- To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
- To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men or women aged 18 to 49 years inclusive.
- •Able and willing to provide written informed consent to participate.
- •Healthy, as determined by medical history, physical examination, and vital signs.
- •Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
- •Willing to provide multiple blood specimens collected by venipuncture.
- •Females should avoid becoming pregnant during the course of the study
- •Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination.
- •Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.
排除标准
- •Persons under 18 years old or 50 years or older.
- •Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
- •Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
- •Persons who have had a prior serious reaction to influenza vaccine.
- •Persons with a history of anaphylactic-type reaction to injected vaccines.
- •Persons with a history of drug or chemical abuse in the year preceding the study.
- •Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study.
- •Persons who received any other vaccine within one week prior to enrollment (may delay enrollment).
- •Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment).
- •Persons currently participating in another research study involving any study medications (medicines or vaccines).
结局指标
主要结局
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
时间窗: 0 to 7 days after vaccination
Solicited local and general symptoms experienced within 7 days after vaccination 1.
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
时间窗: 14 days after vaccination
Solicited local and general symptoms experienced within 14 days after vaccination 2
次要结局
- Anti-M2e Serum Antibody Concentration(42 days (+/- 2))
研究者
研究点 (2)
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