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

Bandim Health Project

Status and phase: Completed; Phase 4

Conditions: Mortality; Vaccines

Treatments: Biological: Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01306006

MV-EPI

Details and patient eligibility

About

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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 9 to 35 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,500 participants in 2 patient groups

MV-for-all

Active Comparator group

Description:

Measles vaccine provided to all children aged 9 months -3 years of age

Treatment:

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

National policy

No Intervention group

Description:

Measles vaccine provided to children aged 9-11 months, if there are sufficient children to open a measles vaccine vial.