Measles Vaccine, Hospital Admission, Mortality, Non-specific (Heterologous) Effects of Vaccines
Conditions
Brief summary
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
BIOLOGICALmeasles vaccine
Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection
OTHERSaline
0.9% NaCl
Sponsors
Bandim Health Project
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-accident mortality or admission (Composite outcome) | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-accidental mortality | 6 and 12 months | Non-accidental mortality. For the secondary outcomes, censoring will be applied for children whom we do not succeed to contact by telephone |
| Non-accidental hospital admission with an overnight stay in any health facility | 6 months | 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 |
| Cause specific hospital admissions at the national hospital. | 6 months | classifying admissions in the main categories: Respiratory infections, Gastro-intestinal infections, Sepsis, Malaria and other |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2 weeks | 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. |
Countries
Guinea-Bissau
Outcome results
None listed