Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-02-07 @ 8:59 AM
Study NCT ID:
NCT02213432
Status:
TERMINATED
Last Update Posted:
2016-02-24
First Post:
2014-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influenza Vaccination in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'whyStopped': 'Insufficient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2014-08-07', 'studyFirstSubmitQcDate': '2014-08-07', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprotection rate', 'timeFrame': '21-28 days after vaccination', 'description': 'The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)'}], 'secondaryOutcomes': [{'measure': 'Seroconversion factor', 'timeFrame': '21-28 days after vaccination', 'description': 'Seroconversion factor is defined as mean fold increases in geometric mean titers of the haemagglutination inhibition(HI) after vaccination, expressed as a multiple.'}, {'measure': 'Seroconversion rate', 'timeFrame': '21-28 days after vaccination', 'description': 'Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre'}, {'measure': 'Geometric mean titre of HI', 'timeFrame': '21-28 days after vaccination', 'description': 'Geometric mean titers of HI (haemagglutination inhibition) after vaccination'}, {'measure': 'Vaccine-related adverse events', 'timeFrame': 'within 28 days', 'description': 'the proportion of patients with any or serious vaccine-related adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['influenza vaccine', 'cancer'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.', 'detailedDescription': 'The participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11 vaccination group.\n\nDay 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group will get the vaccine at Day 11, 10 days after chemotherapy begins.\n\nAs the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.\n\nHemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants.\n\nAll the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer.\n\n Specific definition of each term is like following:\n * The solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies.\n * Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks.\n * Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as Xeloda are excluded.\n2. Patients who did not receive the influenza vaccination yet in the current year.\n3. Older than 19 years\n4. Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2\n5. Cell blood count meets following criteria:\n\n * Neutrophile count ≥ 1.5 x 10\\^9/L\n * Platelet count ≥ 100 x 10\\^9/L\n * Hemoglobin ≥ 8 g/dL\n6. Patients who can understand and agreed with the informed consents.\n\nExclusion Criteria:\n\n1. Patients who have any contraindication for influenza vaccination.\n2. Patients who are supposed to receive the last chemotherapy at the enrollment\n3. Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy\n4. Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)\n5. Patients with HIV and low CD 4+ T cell count (\\< 500/uL)\n6. Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine\n7. Patients who have transplanted organ and receive immunosuppressants\n8. Patients who are supposed to get prophylactic G-CSF after chemotherapy\n9. Patients who are suspected to have active infectious disease.'}, 'identificationModule': {'nctId': 'NCT02213432', 'briefTitle': 'Influenza Vaccination in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy', 'orgStudyIdInfo': {'id': '1407-057-593'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Day 1 vaccination', 'description': 'Different timing of influenza vaccination: Day 1\n\nDay 1 vaccination group: patients will be vaccinated against influenza at the day (Day 1) when chemotherapy starts.', 'interventionNames': ['Biological: Different timing of influenza vaccination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Day 11 vaccination', 'description': 'Different timing of influenza vaccination: Day 11\n\nDay 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts', 'interventionNames': ['Biological: Different timing of influenza vaccination']}], 'interventions': [{'name': 'Different timing of influenza vaccination', 'type': 'BIOLOGICAL', 'description': 'The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.', 'armGroupLabels': ['Day 1 vaccination', 'Day 11 vaccination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Wan Beom Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wan Beom Park', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}