NCT01575197已完成4 期
Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana
PATH1 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2012年9月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules
研究概览
简要总结
The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.
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
- None
入排标准
- 年龄范围
- 42 Days 至 55 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 42 and 55 days of age at the time of enrollment.
- •Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
- •Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.
排除标准
- •If child has previously had intussusception or abdominal surgery.
- •Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
- •Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
- •Birthweight less than 2000 grams or gestation < 36 weeks, if this information is available.
- •Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
- •Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
- •After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
- •The child has received rotavirus vaccine outside of this study.
结局指标
主要结局
Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules
时间窗: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre-vaccination as measured by Enzyme Immunoassay (EIA).
次要结局
- SAE Assessment(Throughout study period; Group 1: from enrollment through approximately 8 weeks of study participation, Groups 2 & 3: from enrollment through approximately 12 weeks of study participation)
- IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules(4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
- IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules(4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
- IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule(4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
- Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination(Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
- Vaccine-type Rotavirus Shedding in Stool(Days 4 and 7 post each study vaccination)
研究者
研究点 (1)
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