Trial | NCT01306006  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3500
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.
Study Started
Feb 28
2011
Primary Completion
Dec 02
2017
Study Completion
Dec 02
2017
Last Update
May 05
2021

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

MV-for-all Active Comparator

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

National policy No Intervention

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

Criteria 

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)
No Results Posted