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

Mortality Clinical Trial

— MVEPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306006
• Other study ID #: MV-EPI
• Status: Completed
• Phase: Phase 4
• Start date: February 2011
• Est. completion date: December 2, 2017

Study information

• Verified date: April 2021
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: December 2, 2017
• Est. primary completion date: December 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 35 Months

Eligibility

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)

Related Conditions & MeSH terms

• Measles
• Mortality
• Vaccines

Intervention

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

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau

Sponsors (2)

Lead Sponsor	Collaborator
Bandim Health Project	Institudo Nacional de Saude Publica INASA

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Secondary	Hospital morbidity

External Links

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