Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 7:10 AM
Study NCT ID:
NCT07282795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 670}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-02-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of solicited injected site reactions.', 'timeFrame': 'Up to 7 days after vaccination', 'description': 'Number of participants experiencing solicited injection site reactions'}, {'measure': 'Occurrence of solicited systemic reactions', 'timeFrame': 'Up to 7 days after vaccination', 'description': 'Number of participants experiencing solicited systemic reactions'}, {'measure': 'Occurrence of unsolicited Adverse Events (AE)', 'timeFrame': 'From vaccination to Visit 2 (up to approximately 42 days)', 'description': 'Number of participants experiencing AEs'}, {'measure': 'Occurrence of unsolicited Adverse Drug Reactions (ADR)', 'timeFrame': 'From vaccination to Visit 2 (up to approximately 42 days)', 'description': 'Number of participants experiencing ADRs'}, {'measure': 'Occurrence of unexpected Adverse Events (AE)', 'timeFrame': "From vaccination to participant's last contact (up to approximately 42 days)", 'description': 'Number of participants experiencing unexpected AEs'}, {'measure': 'Occurrence of unexpected Adverse Drug Reactions (ADR)', 'timeFrame': "From vaccination to participant's last contact (up to approximately 42 days)", 'description': 'Number of participants experiencing unexpected ADRs'}, {'measure': 'Occurrence of Serious Adverse Events (SAE)', 'timeFrame': "From vaccination to participant's last contact (up to approximately 42 days)", 'description': 'Number of participants experiencing SAEs'}, {'measure': 'Occurrence of unexpected Serious Adverse Drug Reactions (SADR)', 'timeFrame': "From vaccination to participant's last contact (up to approximately 42 days)", 'description': 'Number of participants experiencing unexpected SADRs'}, {'measure': 'Occurrence of Adverse Event of Special Interest (AESI)', 'timeFrame': "From vaccination to participant's last contact (up to approximately 42 days)", 'description': 'Number of participants experiencing AESIs'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flu', 'Efluelda®'], 'conditions': ['Influenza Immunization', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To objective of this study is to investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda® in adults aged 65 years or older under routine clinical practice, as per approved indications This is an open-label, multi-center, observational active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Regulation on the Operation of Risk Management Plans".\n\nThe study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators will recruit participants after vaccination with Efluelda® as per routine healthcare visits and according to approved local product labeling, at study centers (general hospitals or clinics located in South Korea).\n\n600 evaluable participants will be included and will include male and female adults aged 65 years and older.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 65 years or older on the day of enrollment\n* The informed consent form has been signed and dated\n* Receipt of 1 dose of Efluelda® on the day of enrollment according to the approved local product label\n\nNote: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.\n\nExclusion Criteria:\n\n* Previous history of enrollment in this study\n* Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure'}, 'identificationModule': {'nctId': 'NCT07282795', 'briefTitle': 'Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe, a High-dose Trivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea', 'orgStudyIdInfo': {'id': 'FIM00018'}, 'secondaryIdInfos': [{'id': 'U1111-1331-8205', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Efluelda® Vaccination Group', 'description': 'Adults aged 65 years of age or older will receive 1 dose of Efluelda® vaccination intramuscularly on Day 1', 'interventionNames': ['Biological: Efluelda® Pre-filled syringe']}], 'interventions': [{'name': 'Efluelda® Pre-filled syringe', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical Form:\n\nSuspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration', 'armGroupLabels': ['Efluelda® Vaccination Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Trial Transparency email recommended (Toll free for US & Canada)', 'role': 'CONTACT', 'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'phoneExt': 'option 6'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}