Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events.
研究概览
简要总结
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
详细描述
The Brazilian National Immunization Program (PNI) has introduced a oral monovalent vaccine against rotavirus for infants in its immunization schedule since 2006. Its introduction increased the Brazilian Ministry of Health budget because the vaccination in Brazil is free of charge. An agreement between Path Foundation and Butantan Institute has made possible the transfer of technology to Butantan Institute to produce, at a reduced cost, a pentavalent rotavirus vaccine including the the rotavirus serotypes more frequent in 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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male healthy
- •Age ≥18-40 years
- •Not taking immunosuppressive drugs
- •No clinical history of gastrointestinal diseases or surgeries
- •No history of cardiac, neurologic, immunologic or endocrine diseases
- •Normal eligibility laboratory tests
- •To be willing to participate and sign the informed consent form
- •No participation in another clinical trial in the past 6 months
排除标准
- •Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
结局指标
主要结局
Number of Participants With Adverse Events.
时间窗: Within the first five days post-vaccination.
Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.
次要结局
- Anti-rotavirus IgA Level.(before each dose (total of doses:3) and after 6 weeks of the third dose)