Clinical Trial: Additional Measles Vaccine at 4 Months of Age

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality and to Explore the Role of Maternal Measles A

Brief Summary:

Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality compared with the WHO strategy of one dose of MV at 9 months.

Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of age1. As in a previous trial it is expected that the beneficial effect is strongest for girls.

Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than children receiving MV at 4 months with no detectable MatAb.

Implications: These hypotheses are based on a previous RCT showing strong beneficial effects of providing an early measles vaccine, in particular among children with MatAb.


Detailed Summary:
Sponsor: Bandim Health Project

Current Primary Outcome: Mortality

Differences in mortality rates between the intervention and control groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Morbidity
    Symptoms of infection
  • Hospitalisations/consultations
    Visits to health center for consultation due to illness, hospitalisation
  • Growth
    Weight, length, arm circumference
  • Measles infection
    Measles infection assessed by medical doctor and/or verified by blood samples


Original Secondary Outcome: Same as current

Information By: Bandim Health Project

Dates:
Date Received: August 3, 2011
Date Started: August 2011
Date Completion:
Last Updated: November 14, 2013
Last Verified: November 2013