Measles Vaccination at Health System Contacts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: measles vaccine, Saline.
- Who it may be relevant to
- Registry conditions: Measles Vaccine, Hospital Admission, Mortality, Non-specific (Heterologous) Effects of Vaccines. Basic parameters: 9 months — 59 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Guinea-Bissau
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Health Effects of Utilising Curative Health System Contacts to Provide Measles Vaccination - a Randomised Controlled Trial
Overview
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.
Interventions
- Biological measles vaccine
Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection - Other Saline
0.9% NaCl
Primary outcome measures
- Non-accident mortality or admission (Composite outcome) [Time frame: 6 months]
Secondary outcome measures (3)
- Non-accidental mortality [Time frame: 6 and 12 months]
- Non-accidental hospital admission with an overnight stay in any health facility [Time frame: 6 months]
- Cause specific hospital admissions at the national hospital. [Time frame: 6 months]
Eligibility criteria
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.
Measles-under-vaccinated children (received first but not second dose of MV)
- 15-59 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Guinea-Bissau · 1 center
- Bandim Health Project — Bissau
Publications
- 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. PMID 35461287
Identifiers
NCT: NCT04220671 · 053/CNES/INASA/2019