A Phase 4 interventional study of measles vaccine and Saline in Measles Vaccine, Hospital Admission and Mortality, sponsored by Bandim Health Project. Enrolling by invitation at 1 site in Guinea-Bissau. Open to participants aged 9 Months to 59 Months. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Bandim Health Project · Phase 4, Interventional, and Prevention
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.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's planned enrollment of 5,400 is above the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →Bandim Health Project is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
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Measles-under-vaccinated children (received first but not second dose of MV)
Exclusion Criteria:
Standard dose measles vaccine, 0.5 ml
Biological: measles vaccine
Saline injection, 0.5 ml
Other: Saline
Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection
0.9% NaCl
Non-accident mortality or admission (Composite outcome)
Composite outcome of non-accidental death (recorded through telephone interviews and passive case detection) or an identified non-accidental hospital admission at the national hospital Simao Mendes
Time frame: 6 months
Non-accidental mortality
Non-accidental mortality. For the secondary outcomes, censoring will be applied for children whom we do not succeed to contact by telephone
Time frame: 6 and 12 months
Non-accidental hospital admission with an overnight stay in any health facility
Since we rely on passive case detection at the national hospital, we will not censor analysis time of children with no information by telephone interviews in the primary analysis. For the secondary outcomes, censoring will be applied for children whom we do not succeed to contact by telephone
Time frame: 6 months
Cause specific hospital admissions at the national hospital.
classifying admissions in the main categories: Respiratory infections, Gastro-intestinal infections, Sepsis, Malaria and other
Time frame: 6 months
Adverse events
Registered contacts with the health system (information on consultations or admissions during the first 2 weeks after enrolment identified through the registration system at the national hospital and registration of outpatient consultations at the health centres in the study area. Among the first 1000 enrolled measles unvaccinated children: Home visits to assess specific symptoms and minor morbidity at day 2, 4, 7 and 14. Among the first 500 enrolled children who have received the first but not the second dose of MV: Telephone follow up after 7 and 14 days.
Time frame: 2 weeks
Plan to share: No — Provided request, data can be made available
Started Jan 2020 (actual). Primary completion is estimated for Dec 2026, 83 months after the start.
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Studies of the drug tested here: Measles Vaccine
Bandim Health Project