Diphteria-tetanus-pertussis (DTP) Vaccination and Child Survival: Randomized Study of Not Providing DTP Vaccination Together With or After Measles Vaccination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6,534
- 试验地点
- 1
- 主要终点
- Mortality till 4 years of age
研究概览
简要总结
In non-randomized studies, routine childhood vaccinations have been observed to have non-targeted effects. Difteria-tetanus-pertussis (DTP) vaccine provided with or after measles vaccine (MV) is associated with increased mortality in areas with herd immunity to pertussis.
We will examine in a randomised study of 6000 children the effect of not administering DTP simultaneously with or after MV on overall child mortality, hospitalization rates, and the immunological responses after vaccination. We will also examine potential sex-differential effects in the outcomes and interactions with other vaccines, other health interventions and season.
详细描述
Background: Infectious diseases are the main cause of high child mortality in Africa. In several non-randomised studies, routine childhood vaccinations have been observed to have non-targeted effects. Live vaccines like measles vaccine (MV) seem to protect against overall mortality, whereas killed vaccines, like DTP, may have no beneficial effects, especially for girls. DTP provided with or after MV may be associated with increased mortality. The mechanisms behind these effects are unknown.
Hypothesis: Not providing DTP together with or after MV is associated with a 35 % reduction in overall mortality and 23% reduction in hospitalizations.
Objectives: To examine in a randomised study of 6000 children the effect of not administering DTP simultaneously with or after MV on
- Overall child mortality
- Hospitalization rates and major causes of hospitalization
- The immunological profile after vaccination
- Sex-differences in the above mentioned outcomes
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child should be missing DTP3 or DTP4
- •The child should have received DTP2
- •The child should have received MV already or receive MV on the day of enrolment
排除标准
- •Normally applied contraindications for receiving vaccinations, including high fever
结局指标
主要结局
Mortality till 4 years of age
时间窗: June 2011
Hospitalisations till 4 years of age
时间窗: June 2011
Adverse events 1 month after intervention
时间窗: December 2008
次要结局
- Immunological responses(July 2008)
- Morbidity(June 2011)