The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age (MVEPI)
Primary Purpose
Mortality, Vaccines
Status
Completed
Phase
Phase 4
Locations
Guinea-Bissau
Study Type
Interventional
Intervention
Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Mortality focused on measuring Mortality, Vaccines
Eligibility 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)
Sites / Locations
- Bandim Health Project
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
MV-for-all
National policy
Arm Description
Measles vaccine provided to all children aged 9 months -3 years of age
Measles vaccine provided to children aged 9-11 months, if there are sufficient children to open a measles vaccine vial.
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Hospital morbidity
Full Information
NCT ID
NCT01306006
First Posted
February 24, 2011
Last Updated
April 30, 2021
Sponsor
Bandim Health Project
Collaborators
Institudo Nacional de Saude Publica INASA
1. Study Identification
Unique Protocol Identification Number
NCT01306006
Brief Title
The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age
Acronym
MVEPI
Official Title
The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 2011 (Actual)
Primary Completion Date
December 2, 2017 (Actual)
Study Completion Date
December 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bandim Health Project
Collaborators
Institudo Nacional de Saude Publica INASA
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mortality, Vaccines
Keywords
Mortality, Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MV-for-all
Arm Type
Active Comparator
Arm Description
Measles vaccine provided to all children aged 9 months -3 years of age
Arm Title
National policy
Arm Type
No Intervention
Arm Description
Measles vaccine provided to children aged 9-11 months, if there are sufficient children to open a measles vaccine vial.
Intervention Type
Biological
Intervention Name(s)
Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine
Intervention Description
Normal measles vaccines licensed for distribution through the national EPI program
Primary Outcome Measure Information:
Title
Mortality
Secondary Outcome Measure Information:
Title
Hospital morbidity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Bandim Health Project
City
Bissau
Country
Guinea-Bissau
12. IPD Sharing Statement
Citations:
PubMed Identifier
33941513
Citation
Byberg S, Aaby P, Rodrigues A, Stabell Benn C, Fisker AB. The mortality effects of disregarding the strategy to save doses of measles vaccine: a cluster-randomised trial in Guinea-Bissau. BMJ Glob Health. 2021 May;6(5):e004328. doi: 10.1136/bmjgh-2020-004328.
Results Reference
derived
Links:
URL
http://www.bandim.org
Description
Related Info
Learn more about this trial
The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age
We'll reach out to this number within 24 hrs