Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 9:35 PM
Study NCT ID:
NCT06511635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-22
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Quantitative and Qualitative Study of the Determinants of Participation in a Cytomegalovirus Preventive Vaccine Study in France in Women Aged 18 to 40 Years Old.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'qualitative interview', 'timeFrame': 'Day : 1', 'description': 'To identify the motivations and the obstacles of participation in an experimental trial in women of childbearing age in Phase 3 trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recruitment methods', 'Determinants', 'CMVCTORY vaccine trial', "women's participation", 'vaccine trial'], 'conditions': ['Recruitment']}, 'descriptionModule': {'briefSummary': "During a vaccine clinical trial of Cytomegalovirus (CMV) vaccine, one of the participants' motivations was to prevent an infection responsible for malformations in a future child. Would their attitude towards a vaccine trial be the same in the context of a vaccine designed to protect them individually? By improving the knowledge of clinical research and determinants in women aged 18 to 40, this study could improve recruitment methods in this specific population for future vaccine trials within the CIC1408 infectious diseases and vaccinology area at Saint-Etienne University Hospital."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All french participants of the CMVCTORY vaccine trial.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Womens between 18 to 40 included in CMVCTORY vaccine trial\n\nExclusion Criteria:\n\n* Refusal'}, 'identificationModule': {'nctId': 'NCT06511635', 'briefTitle': 'Multicenter Quantitative and Qualitative Study of the Determinants of Participation in a Cytomegalovirus Preventive Vaccine Study in France in Women Aged 18 to 40 Years Old.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Multicenter Quantitative and Qualitative Study of the Determinants of Participation in a Cytomegalovirus Preventive Vaccine Study in France in Women Aged 18 to 40 Years Old.', 'orgStudyIdInfo': {'id': 'IRBN432024/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women between 18 to 40 included in CMVCTORY vaccine trial', 'description': 'Women between 18 to 40 included in CMVCTORY vaccine trial will be included.', 'interventionNames': ['Other: Qualitative interview', 'Other: Quantitative questionnaire']}], 'interventions': [{'name': 'Qualitative interview', 'type': 'OTHER', 'description': 'Interview between participant and a researcher, in order to identity the determinants of participation in a clinical trial among participants in the CMVictory vaccine trial.', 'armGroupLabels': ['Women between 18 to 40 included in CMVCTORY vaccine trial']}, {'name': 'Quantitative questionnaire', 'type': 'OTHER', 'description': 'Anonymous online survey using a 3-part questionnaire, studying knowledge of clinical research and the determinants of participation in a preventive vaccine study in a population of young women (aged 18-40).', 'armGroupLabels': ['Women between 18 to 40 included in CMVCTORY vaccine trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'contacts': [{'name': 'Nelly JACQUEMET, Nurse', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amandine GAGNEUX-BRUNON, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maëlle DETOC, CRA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elisabeth NOTELHO-NEVERS, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de St Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Nelly JACQUEMET, nurse', 'role': 'CONTACT', 'email': 'rechercheclinique.infectiologie.IDE@chu-st-etienne.fr', 'phone': '(0)477829658', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Nelly JACQUEMET, nurse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}