{"doc_desc":{"title":"\u00c9tude transversale sur les enfants de 27 mois et moins \u00e9ligibles \u00e0 la politique vaccinale : \u00e9volution de l'acceptabilit\u00e9 de la vaccination contre l'h\u00e9patite B avant le remboursement d'InfanrixHexa\u00ae","idno":"FRESH-PEF160-fr","producers":[{"name":"Christel LECLERC-ZWIRN","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF160-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"160"},{"agency":"FReSH","code":"FRESH-PEF160"}]},"title":"\u00c9tude transversale sur les enfants de 27 mois et moins \u00e9ligibles \u00e0 la politique vaccinale : \u00e9volution de l'acceptabilit\u00e9 de la vaccination contre l'h\u00e9patite B avant le remboursement d'InfanrixHexa\u00ae","alternate_title":"PRALINE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Christel;LECLERC-ZWIRN","firstname":"Christel","lastname":"LECLERC-ZWIRN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87","role":"organisation id"},{"title":"SIREN","uri":"592052146","role":"organisation id"}],"email":"christel.c.leclerc-zwirn@gsk.com","affiliationName":"GLAXOSMITHKLINE (FRANCE)","PILabo":"Laboratoire GSK","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87","role":"sponsor id"},{"title":"SIREN","uri":"592052146","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]}]},"distribution_statement":{"contact":[{"name":"Christel;LECLERC-ZWIRN","lastname":"LECLERC-ZWIRN","firstname":"Christel","type":"contact","email":"christel.c.leclerc-zwirn@gsk.com","affiliationName":"GLAXOSMITHKLINE (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00z1h3j87","role":"organisation id","title":"ROR"},{"uri":"592052146","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"vaccin"},{"keyword":"pratique vaccinale"}],"topics":[{"topic":"Immunologie m\u00e9dicale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"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":"Vaccins contre l'h\u00e9patite","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/396699965","title":"CIM-11"}]}],"purpose":"Mesurer, en m\u00e9decine g\u00e9n\u00e9rale et p\u00e9diatrique, l\u2019\u00e9volution de l\u2019acceptabilit\u00e9 de la vaccination contre l\u2019h\u00e9patite B des enfants de 27 mois et moins avant le remboursement d\u2019InfanrixHexa\u00ae, puis au cours des trois ann\u00e9es suivantes en France","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2012-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\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    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u2022Enfants du registre d\u2019\u00e9ligibilit\u00e9 soumis \u00e0 la politique vaccinale de l\u2019investigateur. Ce crit\u00e8re sera \u00e9valu\u00e9 \u00e0 partir des d\u00e9clarations des m\u00e9decins, via 2 questions : 1.\u00ab Suivez-vous l\u2019enfant depuis sa naissance ? Si oui : date de la 1\u00e8re consultation de l\u2019enfant. Si non : suiviez-vous l\u2019enfant sur ses 6 premiers mois ? \u00bb 2.\u00ab Etes-vous le m\u00e9decin en charge de la vaccination de cet enfant depuis sa naissance ? \u00bb\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Autres"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"928 practitioners 13920 infants"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Le m\u00e9decin investigateur compl\u00e9tera les deux registres d\u2019\u00e9ligibilit\u00e9. Si le carnet de vaccination n\u2019est pas disponible le jour de la consultation, le m\u00e9decin demandera au parent de l\u2019enfant de fournir le carnet de vaccination dans les jours suivants et finira alors de compl\u00e9ter les donn\u00e9es de vaccination dans le registre. Si le carnet de vaccination n\u2019est pas disponible lors de la consultation, les donn\u00e9es cl\u00e9s sur la vaccination de l\u2019enfant seront compl\u00e9t\u00e9es \u00e0 l\u2019aide du dossier patient du m\u00e9decin en notifiant l\u2019absence du carnet de vaccination.Le questionnaire d\u2019acceptabilit\u00e9 (CRF papier) sera administr\u00e9 aux m\u00e9decins participants par un attach\u00e9 de recherche clinique, par t\u00e9l\u00e9phone, lors de l\u2019implantation du centre.Les donn\u00e9es seront recueillies dans le registre d\u2019\u00e9ligibilit\u00e9 pour l\u2019ensemble des patients de 12 \u00e0 15 mois et de 24 \u00e0 27 mois consultant spontan\u00e9ment l\u2019investigateur sur la dur\u00e9e de l\u2019\u00e9tude","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}