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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age

Conditions
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Mortality, Vaccines

Intervention / Treatment
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* Biological: Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MV-for-all<br>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<br>* Normal measles vaccines licensed for distribution through the national EPI program<br>|
| No Intervention: National policy<br>Measles vaccine provided to children aged 9-11 months, if there are sufficient children to open a measles vaccine vial. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital morbidity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mortality, Vaccines