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Enrolling by Invitation

NCT Number: NCT04220671

Measles Vaccination at Health System Contacts

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.

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Key information

Conditions

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

Age range

9 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bandim Health Project

Bissau, Guinea-Bissau

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measles vaccine

Biological

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

Saline

Other

0.9% NaCl

Primary outcomes

  1. 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

Secondary outcomes

  1. Non-accidental mortality

    Time frame: 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

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

    Time frame: 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

  3. Cause specific hospital admissions at the national hospital.

    Time frame: 6 months

    classifying admissions in the main categories: Respiratory infections, Gastro-intestinal infections, Sepsis, Malaria and other

Other outcomes

  1. Adverse events

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2020
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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