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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Bandim Health Project.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306006
First Posted: March 1, 2011
Last Update Posted: August 7, 2014
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.
Collaborator:
Institudo Nacional de Saude Publica INASA
Information provided by (Responsible Party):
Bandim Health Project
February 24, 2011
March 1, 2011
August 7, 2014
February 2011
December 2015   (Final data collection date for primary outcome measure)
Mortality
Same as current
Complete list of historical versions of study NCT01306006 on ClinicalTrials.gov Archive Site
Hospital morbidity
Same as current
Not Provided
Not Provided
 
The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age
The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Mortality
  • Vaccines
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
  • Active Comparator: MV-for-all
    Measles vaccine provided to all children aged 9 months -3 years of age
    Intervention: Biological: Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine
  • No Intervention: National policy
    Measles vaccine provided to children aged 9-11 months, if there are sufficient children to open a measles vaccine vial.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
3500
December 2016
December 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
9 Months to 35 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
 
NCT01306006
MV-EPI
Not Provided
Not Provided
Not Provided
Bandim Health Project
Bandim Health Project
Institudo Nacional de Saude Publica INASA
Not Provided
Bandim Health Project
August 2014

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