The Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding Around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PATH
- 入组人数
- 1,140
- 试验地点
- 1
- 主要终点
- Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml
研究概览
简要总结
Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives:
- To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life.
- To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.
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
- 6 Weeks 至 18 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
- •Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
- •Written informed consent obtained from the parents or guardians.
排除标准
- •Hypersensitivity to any of the vaccine components.
- •Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
- •Use of any immunosuppressive drugs.
- •Previous intussusception or abdominal surgery.
- •Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
- •Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
- •Immunoglobulin and/or blood products use since birth or during the study period.
研究组 & 干预措施
Baseline seroconversion for rotavirus
EPI vaccines
Primary 2: Rotavirus vaccine withholding breast feeding
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding
干预措施: Rotavirus vaccine (Biological)
Primary 2: Rotavirus vaccine with immediate breast feeding
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding
干预措施: Rotavirus vaccine (Biological)
Primary 1: Rotavirus vaccine 10 and 14 weeks
EPI vaccines + rotavirus vaccine at 10 and 14 weeks
干预措施: Rotavirus vaccine (Biological)
Primary 1: Rotavirus vaccine 6, 10 and 14 weeks
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks
干预措施: Rotavirus vaccine (Biological)
Primary 1: Rotavirus vaccine 6 and 10 weeks
EPI vaccines + rotavirus vaccine at 6 and 10 weeks
干预措施: Rotavirus vaccine (Biological)
结局指标
主要结局
Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml
时间窗: 6, 10, 14 and 18 weeks
次要结局
未报告次要终点