Measles Vaccination at Health System Contacts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

5400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Additional Measles Vaccine at 4 Months of Age

NCT01486355

Measles Infection

UNKNOWN PHASE4

A Second Dose of Measles Vaccine (MV) in the Second Year of Life

NCT02943681

Child Mortality Child Morbidity

COMPLETED NA

Non-Specific Effects of Standard Titre Measles Vaccination

NCT00168662

Measles

COMPLETED PHASE4

Trial of Additional Measles Vaccine to Reduce Child Mortality

NCT01644721

Measles Vaccine

COMPLETED PHASE4

Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso.

NCT01668745

Measles Vaccine

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Standard dose measles vaccine, 0.5 ml

Group Type EXPERIMENTAL

measles vaccine

Intervention Type BIOLOGICAL

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

Control

Saline injection, 0.5 ml

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

0.9% NaCl

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

measles vaccine

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

Intervention Type BIOLOGICAL

Saline

0.9% NaCl

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.