Measles Vaccination at Health System Contacts

Study Overview
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Brief Summary
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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. 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-unvaccinated 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.

Official Title
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Health Effects of Utilising Curative Health System Contacts to Provide Measles Vaccination - a Randomised Controlled Trial

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

Intervention / Treatment
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* Biological: measles vaccine
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Measles-unvaccinated children 9-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes. Exclusion Criteria: Axil temperature >38.0 Mid upper arm circumference <110 mm

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Standard dose measles vaccine, 0.5 ml | Biological: measles vaccine<br>* Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection<br>|
| Placebo Comparator: Control<br>Saline injection, 0.5 ml | Other: Saline<br>* 0.9% NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |