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Main
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Note: This record shows only the 20 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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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201301000454298 |
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Date of registration:
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12/11/2012 |
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Primary sponsor: |
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Public title:
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Identifying interventions to improve immunization safety (4ISAFETY)
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Scientific title:
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VACCINES SAFETY: EFFECT OF SUPERVISION AND SMS ON IMPROVING THE REPORTING RATE OF ADVERSE EVENTS FOLLOWING IMMUNIZATION. |
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Date of first enrolment:
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2012-11-26 |
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Target sample size:
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480 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201301000454298 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
stratified allocation (factors used to stratify are: Health region, category of health facilities),
Allocation will be determined by the holder of the sequence who is situated off site,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Blaise
Genton |
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Address:
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Socinstrasse 57, 4002 Basel
4002
Basel
Switzerland |
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Telephone:
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+41 79 556 58 68 |
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Email:
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Blaise.Genton@unibas.ch |
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Affiliation:
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Project leader |
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Name:
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Lazare
Kaptue |
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Address:
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Clinique Batos
1937
Yaound?
Cameroon |
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Telephone:
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00237 77 93 42 32 |
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Email:
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prkaptue@hotmail.com |
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Affiliation:
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President Cameroon National Ethics Committee |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion and criteria
At health facility level
? Be officially recognized and situated in a health district involved in the December 2012 meningitis immunization campaign,
? Have at least one health personnel,
? Be providing permanent health care
At health personnel level
? Be in charge or involved in AEFI surveillance
? Be owner of a cell phone and subscriber of any of local telephone company
? Accept to be present during the intervention phase of the study period
Exclusion criteria: Exclusion criteria
At health facility level
? Refusal to participate of the head of the health facility,
? Not covered by any of local telephone company network,
At health personnel level
? Not involved in AEFI surveillance,
? Be a a trainee,
? Target number of participants required (sample size)
Age minimum:
21 Year
Age maximum:
65 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Immunization safety
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Primary Outcome(s)
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AEFI reporting rate, Serious AEFI investigation rate
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Secondary Outcome(s)
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EAFI detection rate, Knowledge of health personnel on AEFI detection, reporting and investigation, Completeness of AEFI reporting form, Promptitude of AEFI reporting
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Secondary ID(s)
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208/CNE/SE/2012
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Source(s) of Monetary Support
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MA . SANTE (Meilleur Acces aux Soins de Sant?)
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Cameroon country bureau WHO
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