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

NCT ID: NCT01306006

Last Updated: 2026-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2017-12-02

Brief Summary

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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

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Conditions

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Mortality Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MV-for-all

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

Normal measles vaccines licensed for distribution through the national EPI program

National policy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

9 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institudo Nacional de Saude Publica INASA

UNKNOWN

Sponsor Role collaborator

Bandim Health Project

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bandim Health Project

Bissau, , Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

References

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McClure BA, Du H, Liu YH, Clarke AE. S-locus products in Nicotiana alata pistils are subject to organ-specific post-transcriptional processing but not post-translational processing. Plant Mol Biol. 1993 Apr;22(1):177-81. doi: 10.1007/BF00039008.

Reference Type RESULT
PMID: 8098964 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33941513 (View on PubMed)

Related Links

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Other Identifiers

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MV-EPI

Identifier Type: -

Identifier Source: org_study_id

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