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临床试验/NCT01199874
NCT01199874已完成4 期

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

PATH1 个研究点 分布在 1 个国家目标入组 1,140 人开始时间: 2011年4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
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:

  1. 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.
  2. 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

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.

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

研究者

发起方
PATH
申办方类型
Other
责任方
Sponsor

研究点 (1)

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