Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT02267733
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2014-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'C000618615', 'term': 'Fluzone High-Dose'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2014-10-13', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Disease Control', 'timeFrame': 'up to 10 months', 'description': 'Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria'}], 'secondaryOutcomes': [{'measure': 'Influenza related morbidity rate', 'timeFrame': 'up to 10 months', 'description': 'Measure the rate of influenza related morbidity at the end of the flu season'}, {'measure': 'Serologic Protection Rate after initial vaccine', 'timeFrame': '30 days post vaccine', 'description': 'Evaluate rates of serologic protection (defined as HAI titer \\> 40) following initial vaccine dose'}, {'measure': 'Serologic Protection Rate after initial vaccine', 'timeFrame': '30 days post booster', 'description': 'Evaluate rates of serologic protection (defined as HAI titer \\> 40) following booster vaccine dose'}, {'measure': 'T cell response', 'timeFrame': '30 day post initial vaccine', 'description': 'Measurement of CD4+/CD8+, NK cells and influenza-specific T cell'}, {'measure': 'T cell response', 'timeFrame': '30 day post booster', 'description': 'Measurement of CD4+/CD8+, NK cells and influenza-specific T cell'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Influenza', 'Gammopathy']}, 'descriptionModule': {'briefSummary': 'A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status', 'detailedDescription': 'In this study, we will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective of age. All patients will receive an initial vaccine followed by a booster vaccine 30 days (+/- 7 days) later and will then be followed for outcomes until the end of flu season.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understand and voluntarily sign an informed consent document\n* Age \\>= 18 years at the time of signing the informed consent form\n* Diagnosis of any monoclonal gammopathy; Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic/ active multiple myeloma, asymptomatic / active Waldenstrom Macroglobulinemia (WM)\n\nExclusion Criteria:\n\n* An serious egg allergy or prior serious adverse reaction to an influenza vaccine\n* Use of any other influenza vaccine for the 2014 to 2015 flu season\n* Women who are pregnant or plan to become pregnant in the study period'}, 'identificationModule': {'nctId': 'NCT02267733', 'acronym': 'SHIVERING', 'briefTitle': 'Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)', 'orgStudyIdInfo': {'id': '1406014244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Disease', 'description': 'Patients not requiring anti-tumor therapy', 'interventionNames': ['Drug: Fluzone']}, {'type': 'EXPERIMENTAL', 'label': 'Disease Requiring Anti-tumor therapy', 'description': 'Patients that have disease requiring anti-tumor therapy at any time', 'interventionNames': ['Drug: Fluzone']}], 'interventions': [{'name': 'Fluzone', 'type': 'DRUG', 'otherNames': ['Fluzone High Dose'], 'description': 'Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration', 'armGroupLabels': ['Disease Requiring Anti-tumor therapy', 'Early Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Andrew Branagan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}