{"doc_desc":{"title":"Surveillance active de la s\u00e9curit\u00e9 des vaccins contre la COVID-19 en vie r\u00e9elle en France via les \u00e9v\u00e9nements rapport\u00e9s par les patients (EVANESCO : Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes)","idno":"FRESH-PEF73996-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73996-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73996"},{"agency":"FReSH","code":"FRESH-PEF73996"}]},"title":"Surveillance active de la s\u00e9curit\u00e9 des vaccins contre la COVID-19 en vie r\u00e9elle en France via les \u00e9v\u00e9nements rapport\u00e9s par les patients (EVANESCO : Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes)","alternate_title":"EVANESCO"},"study_authorization":{"agency":[{"name":"CPP"},{"name":"ANSM"}]},"authoring_entity":[{"type":"investigator","name":"Caroline;DUREAU-POURNIN","PILabo":"University of Bordeaux \/ Bordeaux PharmacoEpi (BPE) Research Platform - Inserm CIC1401","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":"Consortium europ\u00e9en coordonn\u00e9 par l'Universit\u00e9 d'Utrecht, Pays-Bas; Centres participants : Pharmacovigilance Centre LAREB, Pays-Bas; Federal Agency for Medicines and Health Products, Belgique; Luxembourg Institute of Health, Luxembourg; University of Verona, Italie; University of Bordeaux, France; DSRU, Angleterre; Paul Ehrlich Institute, Allemagne; HALMED, Croatie","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"COVID-19"},{"keyword":"vaccins"},{"keyword":"r\u00e9actions ind\u00e9sirables"}],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Estimer les taux d\u2019incidence des r\u00e9actions ind\u00e9sirables (adverse drug reactions, ADR) rapport\u00e9es par les personnes vaccin\u00e9es contre la COVID-19 selon les vaccins utilis\u00e9s en France, en temps quasi-r\u00e9el. Objectifs secondaires : - D\u00e9crire le taux d\u2019incidence des ADR selon le vaccin utilis\u00e9 et les populations sp\u00e9cifiques concern\u00e9es : femmes enceintes, personnes pr\u00e9sentant des comorbidit\u00e9s s\u00e9v\u00e8res (personnes fragiles, personnes pr\u00e9sentant des maladies auto-immunes), personnes \u00e2g\u00e9es, enfants, personnes r\u00e9cemment vaccin\u00e9es par un autre vaccin ; - D\u00e9tecter de nouveaux signaux de s\u00e9curit\u00e9 potentiels ; - Identifier les facteurs de risque possibles des ADR.","abstract":"","coll_dates":[{"start":"2021-01-01","end":"2023-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"La population d\u2019\u00e9tude sera constitu\u00e9e de l\u2019ensemble des personnes vaccin\u00e9es contre la COVID-19 en France :  - Remplissant le questionnaire initial dans les 2 jours apr\u00e8s la premi\u00e8re injection du vaccin, - Comprenant la langue fran\u00e7aise, - Fournissant leur num\u00e9ro de t\u00e9l\u00e9phone ou adresse e-mail, - Donnant leur accord de participation.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"['Codage MedDRA des r\u00e9actions ind\u00e9sirables']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"6640 personnes vaccin\u00e9es en France"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"15-03-2021","lastUpdatedAuto":null,"lastUpdatedManual":"07-03-2023","isContributorPI":"Non","contributorName":"C\u00e9cile DROZ-PERROTEAU","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (Europe)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":"Non"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Recueil via une application internet s\u00e9curis\u00e9e d\u00e9di\u00e9e, avec saisie des donn\u00e9es par les personnes vaccin\u00e9es.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Centres de vaccination au niveau national et pharmacies bordelaises acceptant de d\u00e9livrer l'information sur l'\u00e9tude aupr\u00e8s des personnes vaccin\u00e9es."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}