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临床试验/NCT00710983
NCT00710983Unknown不适用

Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

Bandim Health Project1 个研究点 分布在 1 个国家开始时间: 2008年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
试验地点
1
主要终点
Mortality by sex

研究概览

简要总结

Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.

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
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Normal birth weight, no overt illness or gross malformations -

排除标准

  • 未提供

研究组 & 干预措施

A

Active Comparator

Oral polio vaccine

干预措施: Oral polio vaccine (Biological)

B

No Intervention

No oral polio vaccine

结局指标

主要结局

Mortality by sex

次要结局

  • Morbidity, growth, immunology

研究者

申办方类型
Other

研究点 (1)

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