Measles Vaccination at Health System Contacts
Primary Purpose
Measles Vaccine, Hospital Admission, Mortality
Status
Enrolling by invitation
Phase
Phase 4
Locations
Guinea-Bissau
Study Type
Interventional
Intervention
measles vaccine
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Measles Vaccine
Eligibility Criteria
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.
Exclusion Criteria:
- Axil temperature >38.0
- Mid upper arm circumference <110 mm
Sites / Locations
- Bandim Health Project
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Standard dose measles vaccine, 0.5 ml
Saline injection, 0.5 ml
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Non-accidental mortality
Non-accidental mortality. For the secondary outcomes, censoring will be applied for children whom we do not succeed to contact by telephone
Non-accidental hospital admission with an overnight stay in any health facility
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
Cause specific hospital admissions at the national hospital.
classifying admissions in the main categories: Respiratory infections, Gastro-intestinal infections, Sepsis, Malaria and other
Full Information
NCT ID
NCT04220671
First Posted
January 5, 2020
Last Updated
January 21, 2022
Sponsor
Bandim Health Project
1. Study Identification
Unique Protocol Identification Number
NCT04220671
Brief Title
Measles Vaccination at Health System Contacts
Official Title
Health Effects of Utilising Curative Health System Contacts to Provide Measles Vaccination - a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bandim Health Project
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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. 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-unvaccinated 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles Vaccine, Hospital Admission, Mortality, Non-specific (Heterologous) Effects of Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Standard dose measles vaccine, 0.5 ml
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Saline injection, 0.5 ml
Intervention Type
Biological
Intervention Name(s)
measles vaccine
Intervention Description
Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
0.9% NaCl
Primary Outcome Measure Information:
Title
Non-accident mortality or admission (Composite outcome)
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Non-accidental mortality
Description
Non-accidental mortality. For the secondary outcomes, censoring will be applied for children whom we do not succeed to contact by telephone
Time Frame
6 and 12 months
Title
Non-accidental hospital admission with an overnight stay in any health facility
Description
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
Time Frame
6 months
Title
Cause specific hospital admissions at the national hospital.
Description
classifying admissions in the main categories: Respiratory infections, Gastro-intestinal infections, Sepsis, Malaria and other
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
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. Home visits to assess specific symptoms and minor morbidity at day 2, 4, 7 and 14.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Exclusion Criteria:
Axil temperature >38.0
Mid upper arm circumference <110 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ane Fisker, MD, PhD
Organizational Affiliation
Bandim Health Project
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bandim Health Project
City
Bissau
Country
Guinea-Bissau
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Provided request, data can be made available
Citations:
PubMed Identifier
35461287
Citation
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.
Results Reference
derived
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Measles Vaccination at Health System Contacts
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