Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201301000454298 Date of Approval: 12/11/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Identifying interventions to improve immunization safety (4ISAFETY)
Official scientific title VACCINES SAFETY: EFFECT OF SUPERVISION AND SMS ON IMPROVING THE REPORTING RATE OF ADVERSE EVENTS FOLLOWING IMMUNIZATION.
Brief summary describing the background and objectives of the trial As the assessment of drug safety from clinical trials is limited in detecting all its potential harmful effects, we need strategies to insure a sustainable surveillance of adverse events following immunization (AEFI). This trial has as objective to determine and compare effects of supervision and SMS in improving the notification and investigation rates of AEFI during a vaccination campaign against meningitis in Cameroon.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) 4 immunization safet
Disease(s) or condition(s) being studied Immunization safety,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/12/2012
Actual trial start date 26/11/2012
Anticipated date of last follow up 29/01/2013
Actual Last follow-up date 22/01/2013
Anticipated target sample size (number of participants) 440
Actual target sample size (number of participants) 480
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
208/CNE/SE/2012 Cameroon National ethichs Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS once per health personnel every ten day 40 days sending every ten days one standardized SMS to one health personnel 110
Control Group supervision every ten days 40 days standardized supervision every ten days of the health personnel in charge of AEFI surveillance in the health facility for 40 days 110 Active-Treatment of Control Group
Control Group SMS and Supervision alternate supervision and SMS every ten days 40 days alternate every ten days either standardized supervision or SMS targeting the health personnel in charge AEFI surveillance for forty days 110 Active-Treatment of Control Group
Control Group no trial intervention no dose 40 days no trial intervention but health facilities could be supervised as routinly bu District Medical Officers 110 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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) 21 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/05/2012 Cameroon National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Face Lycee de Nkoleton Yaoundé 1937 Cameroon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/05/2012 Cameroon National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Face Lycéé de Nkoleton Yaoundé 1397 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome AEFI reporting rate, Serious AEFI investigation rate At the end of interventions
Secondary Outcome EAFI detection rate, Knowledge of health personnel on AEFI detection, reporting and investigation, Completeness of AEFI reporting form, Promptitude of AEFI reporting At the end of interventions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adamaoua Health Region It will be a community based interventions in two health regions No applicable No applicable Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Cameroon country bureau WHO Montée Bastos, Yaoundé Bastos, Yaounde Yaoundé Montée Bastos, Yaou Cameroon
MA . SANTE (Meilleur Acces aux Soins de Santé) Avenue de mvolye Yaoundé 33490 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cameroon Ministry of Public Health Boulevard Douala Manga Bell Yaoundé Boulevard Douala Ma Cameroon Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Ateudjieu Jerome Boulevard Douala Manga Bell Yaoundé Boulevard Douala M Cameroon
¿ Prof. Blaise Genton PolycliniqueMédicaleUniversitaire, Bugnon Lausanne 44, 1005 Switzerland
Dr Beat Stoll Médecine interne FMH, Institut de médecine sociale et préventive Geneva 1211 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jerome Ateudjieu atdjerom@yahoo.fr 0023799701011 Boulevard Douala Manga Bell
City Postal code Country Position/Affiliation
Yaoundé 33490 Cameroon Research Officer Division of Health Operations Research
Role Name Email Phone Street address
Public Enquiries Lazare Kaptue prkaptue@hotmail.com 00237 77 93 42 32 Clinique Batos
City Postal code Country Position/Affiliation
Yaoundé 1937 Cameroon President Cameroon National Ethics Committee
Role Name Email Phone Street address
Scientific Enquiries Blaise Genton Blaise.Genton@unibas.ch +41 79 556 58 68 Socinstrasse 57, 4002 Basel
City Postal code Country Position/Affiliation
Basel 4002 Switzerland Project leader
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information