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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01644721 |
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Date of registration:
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17/07/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of Additional Measles Vaccine to Reduce Child Mortality
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Scientific title:
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A Two-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso and Guinea-Bissau |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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3750 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01644721 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Guinea-Bissau
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Contacts
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Name:
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Cesario Martins, MD, PhD |
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Address:
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Telephone:
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Email:
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c.martins@bandim.org |
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Affiliation:
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Name:
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Amabelia Rodrigues, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bandim Health Project |
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Name:
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Cesario Martins, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bandim Health Project |
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Name:
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Peter Aaby, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bandim Health Project |
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Name:
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Cesario Martins, MD, PhD |
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Address:
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Telephone:
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Email:
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c.martins@bandim.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Children who
- received the third dose of pentavalent vaccine at least 28 days before enrolment
- are between 4 and 6 months old
- belong to households of the existing HDSS
Exclusion Criteria:
Children
- with serious malformation
- who are severely sick (needing hospitalisation)
- with high fever (>38.5 C axillary temperature)
- who are severely malnourished (mid-upper-arm-circumference (MUAC) < 110 mm and/or
bilateral peripheral oedema)
- who have received neonatal vitamin A supplementation
- whose parents/guardians state that they intend to permanently move out of the study
area before the child reaches 9 months of age
Age minimum:
4 Months
Age maximum:
6 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Measles Vaccine
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Intervention(s)
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Biological: Early measles vaccine
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Primary Outcome(s)
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Mortality
[Time Frame: 4 months - 3 years]
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Secondary Outcome(s)
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Antibody titres
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Morbidity
[Time Frame: 4 months - 3 years of age]
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Mortality
[Time Frame: 4 to 9 months of age and from 9 months to 3 years of age]
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Growth
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Secondary ID(s)
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OPTIMUNISE_BHP_early MV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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