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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Bandim Health Project
Sponsor:
Collaborators:
Centre de Recherche en Sante de Nouna, Burkina Faso
Navrongo Health Research Centre, Ghana
Heidelberg University
Medical Research Council Unit, The Gambia
Information provided by (Responsible Party):
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01668745
First received: August 16, 2012
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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 50% 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 50% reduction in overall mortality at each site the investigators intend to enroll at least 2,650 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 Intervention Phase
Measles Vaccine
Biological: Early measles vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multi-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso, Ghana, and Guinea-Bissau. Burkina Faso Protocol.

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality [ Time Frame: 4 months - 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 4 to 9 months of age and from 9 months to 3 years of age ] [ Designated as safety issue: Yes ]
  • Morbidity [ Time Frame: 4 months - 3 years of age ] [ Designated as safety issue: Yes ]
  • Growth [ Time Frame: 4 months to 3 years of age ] [ Designated as safety issue: No ]
  • Antibody titres [ Time Frame: 9 months to 3 years of age ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Immunological markers [ Time Frame: 9 months to 3 years of age ] [ Designated as safety issue: No ]
    Provided funding becomes available


Estimated Enrollment: 3190
Study Start Date: May 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668745

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

Locations
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
Medical Research Council Unit, The Gambia
  More Information

Publications:
Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01668745     History of Changes
Other Study ID Numbers: OPTIMUNISE_NOUNA_early MV
Study First Received: August 16, 2012
Last Updated: August 23, 2013
Health Authority: Burkina Faso: Ministry of Health

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

Additional relevant MeSH terms:
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014