NCT01111968已完成1 期
Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 4
- 主要终点
- the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
研究概览
简要总结
This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.
详细描述
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health adults of both genders
- •Age ≥ 18 ≤ 50 years
- •Able to understand every required study procedure
- •Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
- •Normal values for pre-stablished laboratory assays
- •Accpetance to participate and sign the consent form
排除标准
- •Any chronic condition
- •Be on immunossupressive or stimulant therapy
- •Have egg alergy
- •Have past history of alergy to sazonal influenza vaccine
- •Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
- •Acute infectious disease during seven days prior vaccination
- •Female on breasthfeeding
- •Confirmed prior infection by pandemic influenza A
- •Participation in another clinical trial in the last 6 months
- •Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
结局指标
主要结局
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
时间窗: 21 days after each vaccination
Volunteers will receive two doses of vaccine,21 days apart.
次要结局
- Safety and tolerability(30 minutes and 72 hours after vaccination)
研究者
研究点 (4)
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