The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age (MVEPI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Bandim Health Project
Sponsor:
Collaborator:
Institudo Nacional de Saude Publica INASA
Information provided by (Responsible Party):
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01306006
First received: February 24, 2011
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts exclusively on children below 12 months of age; children who have reached 12 months of age are no longer entitled to vaccines through the EPI program. This has affected the measles vaccination coverage, approx. 30% of the children in the rural area do not receive measles vaccine (MV).

Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on survival, reducing mortality by approximately 50% - far more than can be explained by prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on survival, and the current policy may have important consequences for overall child mortality.

To test the implications of the current policy of only vaccinating children below 12 months of age, the investigators will conduct a cluster randomized trial, in which children will receive their vaccines according to the current national EPI policy (National policy) or receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).

The investigators hypothesise that among children enrolled after 12 months of age, mortality is 50% lower in children randomised to receive MV compared with children randomised to follow the national policy and not receive MV.


Condition Intervention Phase
Mortality
Vaccines
Biological: Providing measles vaccine for all children 9-35 months who have not yet received a routine 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: The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality

Secondary Outcome Measures:
  • Hospital morbidity

Estimated Enrollment: 3500
Study Start Date: February 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MV-for-all
Measles vaccine provided to all children aged 9 months -3 years of age
Biological: Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine
Normal measles vaccines licensed for distribution through the national EPI program
No Intervention: National policy
Measles vaccine provided to children aged 9-11 months, if there are sufficient children to open a measles vaccine vial.

  Eligibility

Ages Eligible for Study:   9 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 9-35 months, not yet received routine measles vaccination, resident in study area

Exclusion Criteria:

  • To ill to be vaccinated (according to local practice)
  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: NCT01306006

Locations
Guinea-Bissau
Bandim Health Project Not yet recruiting
Bissau, Guinea-Bissau
Contact: Ane B Fisker, MD       a.fisker@bandim.org   
Contact: Christina Rasmussen       crn@ssi.dk   
Principal Investigator: Ane B Fisker, MD         
Principal Investigator: Amabelia Rodrigues, PhD         
Principal Investigator: Christine S Benn, MD, PhD         
Principal Investigator: Peter Aaby, DMSC         
Bandim Health Project Recruiting
Bissau, Guinea-Bissau
Contact: Ane Fisker, MD       a.fisker@bandim.org   
Sponsors and Collaborators
Bandim Health Project
Institudo Nacional de Saude Publica INASA
  More Information

Additional Information:
No publications provided

Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01306006     History of Changes
Other Study ID Numbers: MV-EPI
Study First Received: February 24, 2011
Last Updated: August 23, 2013
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
Mortality
Vaccines

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

ClinicalTrials.gov processed this record on July 24, 2014