Measles Vaccination at Health System Contacts

Bandim Health Project

Status and phase: Invitation-only; Phase 4

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

Treatments: Biological: measles vaccine; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04220671

053/CNES/INASA/2019

Details and patient eligibility

About

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.

Enrollment: 5,400 estimated patients

Sex: All

Ages: 9 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,400 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Standard dose measles vaccine, 0.5 ml

Treatment:

Biological: measles vaccine

Control

Placebo Comparator group

Description:

Saline injection, 0.5 ml

Treatment:

Other: Saline