Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT04869735
Status:
UNKNOWN
Last Update Posted:
2021-07-06
First Post:
2021-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Information About Booster Vaccination Against DTPolio at 25 Years on This Booster Vaccination's Realization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-01', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DTPolio vaccine delivery', 'timeFrame': '12 months', 'description': 'DTPolio vaccine delivery by pharmacies within 12 months of sending information about booster vaccination against DTPolio at 25 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Booster vaccination', 'Adult', 'Information', 'DTPolio'], 'conditions': ['Vaccination']}, 'descriptionModule': {'briefSummary': 'The aim of vaccination is to protect the patient against disease by stimulating his immune system. DTPolio is a tetravalent vaccine providing protection against pertussis, diphtheria, tetanus and polio.\n\nIn France, the vaccination schedule sets the vaccination recommendations applicable to people according to their age. In this schedule, a booster of DTPolio at the age of 25 is recommended.\n\nThe vaccination coverage for patients over 16 years of age is insufficient in France.', 'detailedDescription': "The aim of the study is to evaluate impact of information about booster vaccination against DTPolio at 25 years on this booster vaccination's realization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People aged 25', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 25 years old in 2020\n* without delivery of DTPolio vaccine in 2019 or 2020\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04869735', 'acronym': 'Info-Vac', 'briefTitle': "Impact of Information About Booster Vaccination Against DTPolio at 25 Years on This Booster Vaccination's Realization", 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': "Impact of Information About Booster Vaccination Against DTPolio at 25 Years on This Booster Vaccination's Realization", 'orgStudyIdInfo': {'id': '2021-003-Info-Vac'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With information about booster vaccination', 'description': 'Adults aged 25 years in 2020 without delivery of DTPolio vaccine in 2019 or 2020, to whom information concerning this vaccination is given', 'interventionNames': ['Other: Data collection: DTPolio vaccine delivery']}, {'label': 'Without information about booster vaccination', 'description': 'Adults aged 25 years in 2020 without delivery of DTPolio vaccine in 2019 or 2020, to whom information concerning this vaccination is not given.', 'interventionNames': ['Other: Data collection: DTPolio vaccine delivery']}], 'interventions': [{'name': 'Data collection: DTPolio vaccine delivery', 'type': 'OTHER', 'description': '"with information about booster vaccination" group: Sending of information concerning booster vaccination against DTPolio at 25 years using letters, emails and SMS "without information about booster vaccination" group: no intervention', 'armGroupLabels': ['With information about booster vaccination', 'Without information about booster vaccination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brigitte VUILLEMIN', 'role': 'CONTACT', 'email': 'vuillemin0Ol@wanadoo.fr', 'phone': '03 24 72 93 77'}, {'name': 'Aline HURTAUD', 'role': 'CONTACT', 'email': 'aline.ohl-hurtaud@univ-reims.fr', 'phone': '06 86 52 46 44'}], 'facility': 'Université de Reims Champagne-Ardenne', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Brigitte VUILLEMIN', 'role': 'CONTACT', 'email': 'vuillemin0Ol@wanadoo.fr', 'phone': '03 24 72 93 77'}], 'overallOfficials': [{'name': 'Brigitte VUILLEMIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Reims CHampahne-Ardenne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}