Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01411358
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2011-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-10', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-08-05', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40.', 'timeFrame': '3 weeks post vaccination', 'description': 'Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['influenza', 'vaccine', 'immunogenicity'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or non-pregnant females and aged ≥ 18 years;\n* Willing and able to adhere to visit schedules and all study requirements;\n* Subjects read and signed the study-specific informed consent.\n\nExclusion Criteria:\n\n* Subject or his/her family is employed by the participated hospital;\n* Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;\n* History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication\n* Personal or family history of Guillain-Barré Syndrome\n* An acute febrile illness within 1 week prior to vaccination;\n* Current upper respiratory illness, including the common cold or nasal congestion within 72 hours\n* Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough\n* Female subjects who are pregnant during the study\n* Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent\n* Immunodeficiency, or under immunosuppressive treatment\n* Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);\n* Receipt of any blood products, including immunoglobulin in the prior 3 months;\n* Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine"}, 'identificationModule': {'nctId': 'NCT01411358', 'briefTitle': 'Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adimmune Corporation'}, 'officialTitle': 'Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects', 'orgStudyIdInfo': {'id': 'FLU11T12A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AdimFlu-S 2011-2012', 'interventionNames': ['Biological: non-elderly aged between 18 and 60', 'Biological: elderly aged over 60']}], 'interventions': [{'name': 'non-elderly aged between 18 and 60', 'type': 'BIOLOGICAL', 'description': 'one dose of 0.5mL AdimFlu-S', 'armGroupLabels': ['AdimFlu-S 2011-2012']}, {'name': 'elderly aged over 60', 'type': 'BIOLOGICAL', 'description': 'one dose of 0.5mL AdimFlu-S', 'armGroupLabels': ['AdimFlu-S 2011-2012']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Gin-Hsiang Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng-Kung University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adimmune Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}