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OpenTrials
Completed

NCT Number: NCT01306006

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

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.

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Key information

Conditions

Age range

9 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bandim Health Project

Bissau, Guinea-Bissau

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Biological

Normal measles vaccines licensed for distribution through the national EPI program

Primary outcomes

  1. Mortality

Secondary outcomes

  1. Hospital morbidity

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Collaborators

  • Institudo Nacional de Saude Publica INASA

Registry information

Acronym: MVEPI

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2011
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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