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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Standard dose measles vaccine, 0.5 ml |
|
| Control | Placebo Comparator | Saline injection, 0.5 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| measles vaccine | Biological | Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 and 12 months |
| Non-accidental hospital admission with an overnight stay in any health facility |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Measles-under-vaccinated children (received first but not second dose of MV)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ane Fisker, MD, PhD | Bandim Health Project | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bandim Health Project | Bissau | Guinea-Bissau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35461287 | Derived | Fisker AB, Martins JSD, Jensen AM, Martins C, Aaby P, Thysen SM. Health effects of utilising hospital contacts to provide measles vaccination to children 9-59 months-a randomised controlled trial in Guinea-Bissau. Trials. 2022 Apr 23;23(1):349. doi: 10.1186/s13063-022-06291-z. |
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Provided request, data can be made available
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| ID | Term |
|---|---|
| D008458 | Measles Vaccine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Saline | Other | 0.9% NaCl |
|
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 |
| 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 | 6 months |
| 2 weeks |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |