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Measles Vaccination at Health System Contacts

StatusEnrolling by Invitation
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Jan 2025 to Dec 2026
    • Study completion date: Aug 2025 to Jun 2027
    • Eligibility criteria expanded, about 30 words
    v6
  2. Primary completion date: Dec 2023 to Jan 2025
    • Study completion date: Dec 2024 to Aug 2025
    v5
  3. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Primary completion date: Feb 2023 to Dec 2023
    • Study completion date: Jul 2023 to Dec 2024
    v4
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2020 to Jan 8, 2020
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04220671
Lead Sponsor Bandim Health Project
Conditions
(from sponsor)		 Measles Vaccine, Hospital Admission, Mortality, Non-specific (Heterologous) Effects of Vaccines
Enrollment 5,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov