Clinical Trial: Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Diphteria-tetanus-pertussis (DTP) Vaccination and Child Survival: Randomized Study of Not Providing DTP Vaccination Together With or After Measles Vaccination

Brief Summary:

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.


Detailed Summary:

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

  1. Overall child mortality
  2. Hospitalization rates and major causes of hospitalization
  3. The immunological profile after vaccination
  4. Sex-differences in the above mentioned outcomes

Methods:

Surveillance system: BHP's demographic surveillance system in Bissau covers 6 districts with a population of 90,000; 3,500 children are born each year.

Hospitalizations: There is only one pediatric ward in Bissau and all hospitalizations are identified in the BHP register.

Vaccinations: Vaccinations are provided and registered at the 3 health centres in the study area.

Intervention: In this study 6000 children are randomised as they come to r
Sponsor: Bandim Health Project

Current Primary Outcome:

  • Mortality till 4 years of age [ Time Frame: June 2011 ]
  • Hospitalisations till 4 years of age [ Time Frame: June 2011 ]
  • Adverse events 1 month after intervention [ Time Frame: December 2008 ]


Original Primary Outcome:

  • Mortality till 4 years of age
  • Hospitalisations till 4 years of age
  • Adverse events 1 month after intervention


Current Secondary Outcome:

  • Immunological responses [ Time Frame: July 2008 ]
  • Morbidity [ Time Frame: June 2011 ]


Original Secondary Outcome:

  • Immunogical responses
  • Morbidity


Information By: Bandim Health Project

Dates:
Date Received: October 25, 2005
Date Started: October 2005
Date Completion:
Last Updated: February 25, 2012
Last Verified: February 2012