Measles Vaccination at Health System Contacts

Phase 4

• Conditions: Measles Vaccine; Hospital Admission; Mortality; Non-specific (Heterologous) Effects of Vaccines
• Interventions: Other: Saline; Biological: measles vaccine

• Registration Number: NCT04220671
• Lead Sponsor: Bandim Health Project

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Study Start: 2020-01-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-01-24
• Primary Completion: 2025-01
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline	Saline injection, 0.5 ml
Intervention	measles vaccine	Standard dose measles vaccine, 0.5 ml

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Guinea-Bissau