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Measles Vaccination at Health System Contacts

NCT04220671 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5400

Last updated 2025-07-29

No results posted yet for this study

Summary

In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and admissions by around 30%.

In Guinea-Bissau 30% of children do not receive a routine MV scheduled at 9 months of age, putting both the individual child's health and measles eradication at risk. The coverage of a second dose of MV, which was added to the Bissau-Guinean vaccination programme in 2022, is even lower. WHO recommends vaccination at health system contacts, including those for curative services. At the paediatric ward of the national hospital in Guinea-Bissau, there are more than 2600 yearly contacts with measles-un or under-vaccinated children aged 9-59 months, but no vaccines are given. In a randomised controlled trial, we will assess the effect of providing MV vs placebo to 5400 children at hospital contacts (at discharge or after an out-patient consultation) to test the hypothesis that MV reduces the risk of admission or death (composite outcome) by 25% over the subsequent 6 months.

Conditions

  • Measles Vaccine
  • Hospital Admission
  • Mortality
  • Non-specific (Heterologous) Effects of Vaccines

Interventions

BIOLOGICAL

measles vaccine

Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection

OTHER

Saline

0.9% NaCl

Sponsors & Collaborators

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Ane Fisker, MD, PhD · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-08
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04220671 on ClinicalTrials.gov