Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT01961960
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Intramuscular ASP7374
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-27', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemagglutination inhibition (HI) antibody titer', 'timeFrame': 'Day 1 and Day 29', 'description': 'evaluated for A/H1N1, A/H3N2, and B'}], 'secondaryOutcomes': [{'measure': 'neutralizing antibody titer', 'timeFrame': 'Day 1 and Day 29', 'description': 'evaluated for A/H1N1, A/H3N2, and B'}, {'measure': 'Local and systemic reactions associated with the vaccination', 'timeFrame': 'Day 1 through Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASP7374', 'Prevention of seasonal influenza'], 'conditions': ['Influenza', 'Vaccine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '61 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy or medically stable, as judged on the basis of history and concurrent diseases.\n* Subject understands procedure of the protocol and is willing to comply with the protocol.\n* Written informed consent has been obtained.\n\nExclusion Criteria:\n\n* Scheduled to receive another vaccine during the study.\n* Received influenza HA vaccine within 180 days prior to screening.\n* Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.\n* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.\n* Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion\n* History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)\n* History of seizures, except for febrile seizures in childhood'}, 'identificationModule': {'nctId': 'NCT01961960', 'briefTitle': 'A Study to Evaluate Intramuscular ASP7374', 'organization': {'class': 'INDUSTRY', 'fullName': 'UMN Pharma Inc.'}, 'officialTitle': 'Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-', 'orgStudyIdInfo': {'id': '7374-CL-0105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP7374 group', 'interventionNames': ['Biological: ASP7374']}], 'interventions': [{'name': 'ASP7374', 'type': 'BIOLOGICAL', 'description': 'intramuscular', 'armGroupLabels': ['ASP7374 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kanto', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMN Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}