Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT00376402
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2006-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of a Pandemic Influenza Vaccine in Elderly Participants
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2007-06'}, 'lastUpdateSubmitDate': '2016-07-17', 'studyFirstSubmitDate': '2006-09-11', 'studyFirstSubmitQcDate': '2006-09-13', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and immunogenicity'}]}, 'conditionsModule': {'keywords': ['Pandemic', 'Influenza', 'Prevention', 'Vaccine', 'Prevention of Pandemic Influenza'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female participants\n\nExclusion Criteria:\n\n* History of clinically significant medical conditions\n* History of Guillain-Barre syndrome or active neurological disease\n* Resident of nursing home or long-term care facility'}, 'identificationModule': {'nctId': 'NCT00376402', 'briefTitle': 'Study of a Pandemic Influenza Vaccine in Elderly Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seqirus'}, 'officialTitle': 'Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants', 'orgStudyIdInfo': {'id': 'CSLCT-PAN-05-24'}}, 'armsInterventionsModule': {'interventions': [{'name': 'H5N1 Pandemic Influenza Vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX, a division of IDT Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6840', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Princess Margaret Hospital for Children', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Peter Richmond, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Hospital for Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seqirus', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Russell Basser', 'oldOrganization': 'CSL Limited'}}}}