Measles Vaccination at Health System Contacts

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mortality; Measles Vaccine; Hospital Admission; Non-specific (Heterologous) Effects of Vaccines
• Intervention / Treatment: Biological: measles vaccine; Other: Saline

• Study Type: Interventional
• Enrollment (Estimated): 5400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Guinea-Bissau
  • Bissau, Guinea-Bissau
    • Bandim Health Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Standard dose measles vaccine, 0.5 ml	Biological: measles vaccine; Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection
Placebo Comparator: Control; Saline injection, 0.5 ml	Other: Saline; 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. 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.	2 weeks

Collaborators and Investigators

• Sponsor: Bandim Health Project
• Investigators: Principal Investigator: Ane Fisker, MD, PhD, Bandim Health Project

Publications and helpful links

General Publications

• Fisker AB, Martins JSD, Jensen AM, Martins C, Aaby P, Thysen SM. Health effects of utilising hospital contacts to provide measles vaccination to children 9-59 months-a randomised controlled trial in Guinea-Bissau. Trials. 2022 Apr 23;23(1):349. doi: 10.1186/s13063-022-06291-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Morbillivirus Infections; Measles
• Other Study ID Numbers: 053/CNES/INASA/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Provided request, data can be made available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No