{"study_desc":{"title_statement":{"idno":"FRESH-PEF5440-en","IDno":{"metadata_no":[{"agency":"PEF","code":"5440"},{"agency":"FReSH","code":"FRESH-PEF5440"}]},"title":"Vaccinology","alternate_title":""},"study_authorization":{"agency":[{"name":"Other"}]},"authoring_entity":[{"name":"Jean-Fran\u00e7ois;NICOLAS","firstname":"Jean-Fran\u00e7ois","lastname":"NICOLAS","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"jean-francois.nicolas@chu-lyon.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM - Institut National de la Sant\u00e9 et de la Recherche \/ Equipe 14 Inserm U1111- CIRI \"Immunologie de l'allergie cutan\u00e9e et vaccination\"","isContact":true},{"name":"Aurore;ROZIERES","firstname":"Aurore","lastname":"ROZIERES","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"uri":"170852768","role":"pi id","title":"IdRef"}],"email":"aurore.rozieres@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM - Institut National de la Sant\u00e9 et de la Recherche","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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"}],"funding_agencies":[{"name":"BECTON DICKINSON FRANCE","extlink":[{"title":"SIREN","uri":"56501711"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]},{"name":""}]},"distribution_statement":{"contact":[{"name":"Jean-Fran\u00e7ois;NICOLAS","lastname":"NICOLAS","firstname":"Jean-Fran\u00e7ois","type":"contact","email":"jean-francois.nicolas@chu-lyon.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]},{"name":"Aurore;ROZIERES","lastname":"ROZIERES","firstname":"Aurore","type":"contact","email":"aurore.rozieres@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"influenza"},{"keyword":"Vaccination"},{"keyword":"immunosenescence"}],"topics":[{"topic":"Clinical immunology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"D000486"}]},{"topic":"","vocab":"cim-11","extLink":[{"uri":"100000000000000005366162204393472","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"1- To characterise immunity response to influenza vaccination in accordance with intradermal or intramuscular injection 2- To characterise immunosenescence markers in populations with no response to influenza vaccines","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"General population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"1) Over 65 years of age 2) Signed and dated consent 3) Able to attend all scheduled visits 4) Health insurance cover\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Biological data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Physical\/biological measurements (blood pressure, weight, biochemistry, imaging, etc.)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1126"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"Data from this cohort is accessible through scientific publications. If other researchers wish to access this data, a request must be made and data will be made available according to good clinical practice. No \"open access\", filtered \"access request\".","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"18-01-2013","lastUpdatedManual":"01-08-2014","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Allergobiotec is responsible for cohort sample collection (Head Dr. Aurore Rozieres, INSERM U1111-CIRI\/HCL).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Lyon and Saint \u00c9tienne"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Biological data related to inflammatory markers","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}