A Prospective Intervention Phase I Study in Three Age De-escalating Group to Assess the Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Solicited symptoms after each immunization
研究概览
简要总结
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
详细描述
To describe the safety of this vaccine after each immunization. To assess preliminary information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.
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
- Double (Participant, Investigator)
盲法说明
The study for the neonates is double-blind, randomized study. While, the study for the adults and childrens is open-labeled study
入排标准
- 年龄范围
- 1 Minute 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo-Neonates
3 doses of 1 ml of Placebo (contains 30% sucrose in DMEM) per oral
干预措施: Placebo (Other)
Rotavirus (Bio Farma) Vaccine-Adult
1 doses of 1 ml of Rotavirus vaccine per oral
干预措施: Rotavirus (Bio Farma) Vaccine (Biological)
Rotavirus (Bio Farma) Vaccine-Neonates
3 doses of 1 ml of Rotavirus vaccine per oral
干预措施: Rotavirus (Bio Farma) Vaccine (Biological)
Rotavirus (Bio Farma) Vaccine-Children
1 doses of 1 ml of Rotavirus vaccine per oral
干预措施: Rotavirus (Bio Farma) Vaccine (Biological)
结局指标
主要结局
Solicited symptoms after each immunization
时间窗: 0-7 days
Number of subjects with solicited systemic and gastrointestinal symptoms in the day 0-7 following each dose of investigational product
次要结局
- Serious adverse events of Rotavirus (Bio Farma) vaccine(28 days)
- Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group(28 days)
- Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group(28 days)
- Serum neutralizing antibody (SNA) following immunization(4-6 weeks after last immunization)
- Adverse events of Rotavirus (Bio Farma) vaccine(28 days)
- Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination(7 days)
- Excretion of rotavirus in stools in neonates group(3-7 days)
- Number of subjects with >=3 times increasing antibody from baseline to post investigational product dosing(4-6 weeks after last immunization)
- Serum anti-rotavirus immunoglobulin (Ig)A following immunization(4-6 weeks after last immunization)
- Geometric Mean Titer (GMT) following immunization(4-6 weeks after last immunization)