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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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8 March 2021 |
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Main ID: |
NCT03460002 |
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Date of registration:
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21/11/2016 |
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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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Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children
RE-CAMP |
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Scientific title:
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A Cluster Randomized Controlled Trial on the Campaign Effect of Measles Vaccine and Oral Polio Vaccine on General Hospital Admissions and Mortality Among Children |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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28000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03460002 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Care Provider).
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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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Aksel Jensen, 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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Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project |
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Name:
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Anshu Varma, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project |
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Name:
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Ane Fisker, 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, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project |
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Name:
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Amabelia Rodrigues, Ph |
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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, Guinea-Bissau |
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Name:
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Peter Aaby, DMSc,Professor |
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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, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project |
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Key inclusion & exclusion criteria
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Inclusion Criteria: Children aged 0-59 months living with families registered in the rural
Bandim Health Project Health and Demographic Surveillance Site are included, provided a
parent/guardian consent.
Exclusion Criteria:
- the child has temperature > 39.0?C or a severe acute illness as defined by the
examining nurse
OR
- the child has as a mid upper arm circumference < 110 mm and is older than 6 months
(most feasible local indicator of AIDS and chronic immunosuppressive disease)
OR
- the child has experienced a severe allergic reaction after previous vaccination, drug
or food.
OR
- the child is enrolled in an ongoing study of Bacillus Calmette Guerin vaccine and is <
2 months old
OR
- For the RECAMP-MV trial: the child is enrolled in RECAMP-OPV
Age minimum:
N/A
Age maximum:
59 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Children
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Morbidity
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Mortality
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Non-specific/Heterologous Effects of Vaccines
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Measles Vaccination
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Oral Polio Vaccine
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Intervention(s)
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Biological: Measles vaccine
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Biological: Oral polio vaccine
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Primary Outcome(s)
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Composite outcome: mortality and hospital admission (measured as a rate)
[Time Frame: Enrolment to end of study (longest follow-up 2 years)]
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Secondary Outcome(s)
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Hospital admission
[Time Frame: Enrolment to end of study (longest follow-up 2 years)]
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Mortality
[Time Frame: Enrolment to end of study (longest follow-up 2 years)]
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Nutritional status
[Time Frame: Enrolment to end of study (longest follow-up 2 years)]
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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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