Clinical Trial: Trial of Additional Measles Vaccine to Reduce Child Mortality

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

Official Title: A Two-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso and Guinea-Bissau

Brief Summary:

Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival.

Objective: To evaluate in a two-site RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention.

Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated.

Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each site the investigators intend to enroll at

Detailed Summary:
Sponsor: Bandim Health Project

Current Primary Outcome: Mortality [ Time Frame: 4 months - 3 years ]

Overall mortality from 4 months to 3 years by sex and age at enrolment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: 4 to 9 months of age and from 9 months to 3 years of age ]
    Mortality from 4 to 9 months of age and from 9 months to 3 years of age
  • Morbidity [ Time Frame: 4 months - 3 years of age ]
    Hospital admissions, consultations, specific morbidity and measles infection
  • Growth
  • Antibody titres


Original Secondary Outcome: Same as current

Information By: Bandim Health Project

Dates:
Date Received: July 17, 2012
Date Started: July 2012
Date Completion: May 2016
Last Updated: August 6, 2014
Last Verified: August 2014