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

Phase 4

Completed

• Conditions: Mortality; Vaccines
• Interventions: Biological: Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine

• Registration Number: NCT01306006
• Lead Sponsor: Bandim Health Project

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-26
• Study First Posted: 2011-03-01
• Primary Completion: 2017-12-02
• Study Completion: 2017-12-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3500

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MV-for-all	Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine	Measles vaccine provided to all children aged 9 months -3 years of age

Primary Outcome Measures

Name	Time	Method
Mortality

Secondary Outcome Measures

Name	Time	Method
Hospital morbidity

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Guinea-Bissau