Measles Vaccination at Health System Contacts

NCT04220671 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: 053/CNES/INASA/2019
• Study Type: interventional
• Target: 5,400
• Locations: 1 country
• Sites: 1

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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Non-accidental mortality

  6 and 12 months

• Non-accidental hospital admission with an overnight stay in any health facility

  6 months

• Cause specific hospital admissions at the national hospital.

  6 months

Other Outcomes (1)

• Adverse events

  2 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Standard dose measles vaccine, 0.5 ml

Biological: measles vaccine

Control

PLACEBO COMPARATOR

Saline injection, 0.5 ml

Other: Saline

Interventions

measles vaccine BIOLOGICAL

Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection

Intervention

Saline OTHER

0.9% NaCl

Control

Eligibility Criteria

• Age: 9 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Measles-unvaccinated children
• 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)
• months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.

You may not qualify if:

• Axil temperature \>38.0
• Mid upper arm circumference \<110 mm

Sponsors & Collaborators

• Bandim Health Project: lead

Study Sites (1)

Bandim Health Project

Bissau, Guinea-Bissau

Location

Related Publications (1)

• 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.

  PMID: 35461287 DERIVED

MeSH Terms

Interventions

Measles Vaccine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ane Fisker, MD, PhD

  Bandim Health Project

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 7, 2020
• Study Start: January 8, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)