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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04220671
Other study ID # 053/CNES/INASA/2019
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date January 8, 2020
Est. completion date August 2025

Study information

Verified date January 2022
Source Bandim Health Project
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 5400
Est. completion date August 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 9 Months to 59 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
measles vaccine
Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection
Other:
Saline
0.9% NaCl

Locations

Country Name City State
Guinea-Bissau Bandim Health Project Bissau

Sponsors (1)

Lead Sponsor Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. Home visits to assess specific symptoms and minor morbidity at day 2, 4, 7 and 14. 2 weeks
Primary 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 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
Secondary 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
Secondary 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
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