NCT04220671

Measles Vaccination at Health System Contacts

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

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,400 (estimated)
• Sponsor: Bandim Health Project · Academic / Other
• Sex: All
• Age: 9 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	measles vaccine	Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection
OTHER	Saline	0.9% NaCl

Timeline

• Start date: 2020-01-08
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2020-01-07
• Last updated: 2025-07-29

Locations

1 site across 1 country: Guinea-Bissau