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

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ClinicalTrials.gov Identifier: NCT01306006
Recruitment Status : Unknown
Verified August 2014 by Bandim Health Project.
Recruitment status was:  Recruiting
First Posted : March 1, 2011
Last Update Posted : August 7, 2014
Sponsor:
Collaborator:
Institudo Nacional de Saude Publica INASA
Information provided by (Responsible Party):
Bandim Health Project

Brief Summary:

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 or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Mortality

Secondary Outcome Measures :
  1. Hospital morbidity


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
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)

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): 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

Additional Information:
Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01306006     History of Changes
Other Study ID Numbers: MV-EPI
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Keywords provided by Bandim Health Project:
Mortality
Vaccines

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs