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

NCT01306006 | Completed Phase 4

• 1 other identifier: MV-EPI
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Mortality; Vaccines

Keywords

Mortality; Vaccines

Outcome Measures

Primary Outcomes (1)

• Mortality

Secondary Outcomes (1)

• Hospital morbidity

Study Arms (2)

MV-for-all

ACTIVE COMPARATOR

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

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

National policy

NO INTERVENTION

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

Interventions

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

MV-for-all

Eligibility Criteria

• Age: 9 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 9-35 months, not yet received routine measles vaccination, resident in study area

You may not qualify if:

• To ill to be vaccinated (according to local practice)

Sponsors & Collaborators

• Bandim Health Project: lead
• Institudo Nacional de Saude Publica INASA: collaborator

Study Sites (1)

Bandim Health Project

Bissau, Guinea-Bissau

Location

Related Publications (1)

• Byberg S, Aaby P, Rodrigues A, Stabell Benn C, Fisker AB. The mortality effects of disregarding the strategy to save doses of measles vaccine: a cluster-randomised trial in Guinea-Bissau. BMJ Glob Health. 2021 May;6(5):e004328. doi: 10.1136/bmjgh-2020-004328.

  PMID: 33941513 RESULT

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: March 1, 2011
• Study Start: February 1, 2011
• Primary Completion: December 2, 2017
• Study Completion: December 2, 2017
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

GU (1)