Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01668745
Recruitment Status : Unknown
Verified August 2014 by Bandim Health Project.
Recruitment status was:  Recruiting
First Posted : August 20, 2012
Last Update Posted : August 7, 2014
Sponsor:
Collaborators:
Centre de Recherche en Sante de Nouna, Burkina Faso
Navrongo Health Research Centre, Ghana
Heidelberg University
National Institute for Public Health and the Environment, RIVM, Holland
Information provided by (Responsible Party):
Bandim Health Project

Tracking Information
First Submitted Date  ICMJE August 16, 2012
First Posted Date  ICMJE August 20, 2012
Last Update Posted Date August 7, 2014
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
Mortality [ Time Frame: 4 months - 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2012)
  • Mortality [ Time Frame: 4 to 9 months of age and from 9 months to 3 years of age ]
  • Morbidity [ Time Frame: 4 months - 3 years of age ]
  • Growth [ Time Frame: 4 months to 3 years of age ]
  • Antibody titres [ Time Frame: 9 months to 3 years of age ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • Mortality [ Time Frame: 4 to 9 months of age and from 9 months to 3 years of age ]
  • Morbidity [ Time Frame: 4 months - 3 years of age ]
  • Growth
  • Antibody titres
Current Other Pre-specified Outcome Measures
 (submitted: August 29, 2012)
Immunological markers [ Time Frame: 9 months to 3 years of age ]
Provided funding becomes available
Original Other Pre-specified Outcome Measures
 (submitted: August 16, 2012)
Immunological markers
Provided funding becomes available
 
Descriptive Information
Brief Title  ICMJE Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso.
Official Title  ICMJE 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 multi-center 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. Three trials are planned in Guinea-Bissau, Ghana 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, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Centre de Recherche en Sante de Nouna. 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 43% reduction in overall mortality at each site the investigators intend to enroll at least 4050 children in Burkina Faso. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored.

Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Measles Vaccine
Intervention  ICMJE Biological: Early measles vaccine
Study Arms  ICMJE
  • Experimental: Early measles vaccine
    The intervention is about to administer an early standard dose of Edmonston-Zagreb (EZ) measles vaccine in addition to the conventional dose. As such children will be randomised to receive either an early measles vaccine at 4 months after DTP3 or not. Thereafter both groups of children will receive the recommended EZ measles vaccine at 9 months of age according to WHO policy.
    Intervention: Biological: Early measles vaccine
  • No Intervention: Control
Publications * Aaby P, Martins CL, Garly ML, Balé C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 6, 2014)
4050
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Children who

  • received the third dose of pentavalent vaccine at least 28 days before enrolment
  • are between 4 and 6 months old
  • belong to households of the existing HDSS

Exclusion Criteria:

Children

  • with serious malformation
  • who are severely sick (needing hospitalisation)
  • with high fever (>38.5 C axillary temperature)
  • who are severely malnourished (mid-upper-arm-circumference (MUAC) < 110 mm and/or bilateral peripheral oedema)
  • who have received neonatal vitamin A supplementation
  • whose parents/guardians state that they intend to permanently move out of the study area before the child reaches 9 months of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Months to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Burkina Faso
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01668745
Other Study ID Numbers  ICMJE OPTIMUNISE_NOUNA_early MV
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bandim Health Project
Study Sponsor  ICMJE Bandim Health Project
Collaborators  ICMJE
  • Centre de Recherche en Sante de Nouna, Burkina Faso
  • Navrongo Health Research Centre, Ghana
  • Heidelberg University
  • National Institute for Public Health and the Environment, RIVM, Holland
Investigators  ICMJE Not Provided
PRS Account Bandim Health Project
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP