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Measles Vaccination at Health System Contacts

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ClinicalTrials.gov Identifier: NCT04220671
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Bandim Health Project

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.


Condition or disease Intervention/treatment Phase
Measles Vaccine Hospital Admission Mortality Non-specific (Heterologous) Effects of Vaccines Biological: measles vaccine Other: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Health Effects of Utilising Curative Health System Contacts to Provide Measles Vaccination - a Randomised Controlled Trial
Actual Study Start Date : January 8, 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Standard dose measles vaccine, 0.5 ml
Biological: measles vaccine
Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection

Placebo Comparator: Control
Saline injection, 0.5 ml
Other: Saline
0.9% NaCl




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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. Home visits to assess specific symptoms and minor morbidity at day 2, 4, 7 and 14.



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Ages Eligible for Study:   9 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220671


Contacts
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Contact: Ane Fisker 32688366 a.fisker@bandim.org

Locations
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Guinea-Bissau
Bandim Health Project Recruiting
Bissau, Guinea-Bissau
Contact: Ane Fisker, MD       a.fisker@bandim.org   
Sponsors and Collaborators
Bandim Health Project
Investigators
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Principal Investigator: Ane Fisker, MD, PhD Bandim Health Project
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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT04220671    
Other Study ID Numbers: 053/CNES/INASA/2019
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Provided request, data can be made available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases