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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01486355 |
Date of registration:
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03/08/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Additional Measles Vaccine at 4 Months of Age
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Scientific title:
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A Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality and to Explore the Role of Maternal Measles Antibodies for the Beneficial Non-specific Effects of Measles Vaccine |
Date of first enrolment:
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August 2011 |
Target sample size:
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Recruitment status: |
Recruiting |
URL:
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http://clinicaltrials.gov/show/NCT01486355 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, 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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Peter Aaby, DMSc |
Address:
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Telephone:
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+45 3268 3950 |
Email:
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p.aaby@bandim.org |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children aged 4 to 7 months who received the third dose of pentavalent vaccine at
least 4 weeks earlier
Exclusion Criteria:
- Malformations
- Severely ill
- Severely malnourished
Age minimum:
4 Months
Age maximum:
7 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Measles Infection
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Intervention(s)
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Biological: Measles vaccine
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Primary Outcome(s)
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Mortality
[Time Frame: Differences in mortality rates between the intervention and control groups]
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Secondary Outcome(s)
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Measles infection
[Time Frame: Measles infection assessed by medical doctor and/or verified by blood samples]
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Hospitalisations/consultations
[Time Frame: Visits to health center for consultation due to illness, hospitalisation]
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Morbidity
[Time Frame: Symptoms of infection]
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Growth
[Time Frame: Weight, length, arm circumference]
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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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