NCT04220671

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

ENROLLING BY INVITATION Phase 4 Last updated 25 July 2025

What this trial tests

Phase 4 trial testing measles vaccine in Measles Vaccine in 5,400 participants. Enrolling by invitation.

Timeline

8 January 2020

Primary endpoint
1 December 2026

1 June 2027

Quick facts

Lead sponsor	Bandim Health Project
Phase	Phase 4
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	5,400
Start date	8 January 2020
Primary completion	1 December 2026
Estimated completion	1 June 2027
Sites	1 location across Guinea-Bissau

Drugs / interventions tested

• measles vaccine — full drug profile →
• Saline

Conditions studied

• Measles Vaccine — all drugs for Measles Vaccine →
• Hospital Admission — all drugs for Hospital Admission →
• Mortality — all drugs for Mortality →
• Non-specific (Heterologous) Effects of Vaccines — all drugs for Non-specific (Heterologous) Effects of Vaccines →

Sponsor

Bandim Health Project — full company profile →

Who can join

Adults 9 Months to 59 Months, any sex, with Measles Vaccine or Hospital Admission. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Non-accident mortality or admission (Composite outcome)
  Time frame: 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Health effects of utilising hospital contacts to provide measles vaccination to children 9-59 months-a randomised controlled trial in Guinea-Bissau.
   Fisker AB, Martins JSD, Jensen AM, Martins C, et al · · 2022 · cited 1× · PMID 35461287 · DOI 10.1186/s13063-022-06291-z