Measles Vaccination at Health System Contacts

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04220671
• Other study ID #: 053/CNES/INASA/2019
• Status: Enrolling by invitation
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

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

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