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

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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Measles Vaccine Biological: Early measles vaccine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : May 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Biological: Early measles vaccine
No Intervention: Control

Outcome Measures

Primary Outcome Measures :
  1. Mortality [ Time Frame: 4 months - 3 years ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 4 to 9 months of age and from 9 months to 3 years of age ]
  2. Morbidity [ Time Frame: 4 months - 3 years of age ]
  3. Growth [ Time Frame: 4 months to 3 years of age ]
  4. Antibody titres [ Time Frame: 9 months to 3 years of age ]

Other Outcome Measures:
  1. Immunological markers [ Time Frame: 9 months to 3 years of age ]
    Provided funding becomes available

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668745

Contact: Ali Sié, MD +22620537043 alisie.crsn@fasonet.bf
Contact: Maurice Yé, MD +22670244811 yemaure@yahoo.fr

Burkina Faso
Centre de Recherche en Sante de Nouna Recruiting
Nouna, Burkina Faso
Contact: Ali Sie, MD, PhD         
Sponsors and Collaborators
Bandim Health Project
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
More Information

Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01668745     History of Changes
Other Study ID Numbers: OPTIMUNISE_NOUNA_early MV
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Keywords provided by Bandim Health Project:
Child mortality
Measles vaccine
Non-specific effects

Additional relevant MeSH terms:
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs