Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT00999206
Status:
COMPLETED
Last Update Posted:
2011-08-26
First Post:
2009-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
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'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-25', 'studyFirstSubmitDate': '2009-10-20', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Vaccine', 'CHMP criteria'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': "A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Female or male subjects \\>= 18 years of age (adults \\>= 18 to \\< =60 years of age or elderly \\>= 61 years of age).\n2. Willing and able to give informed consent before any protocol procedures are performed.\n3. Able to adhere to visit schedules and all protocol required study procedures.\n4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).\n\nExclusion Criteria\n\n1. Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).\n2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.\n3. A serious adverse reaction after a previous (influenza) vaccination.\n4. A history of Guillain-Barré syndrome.\n5. Known to be allergic to constituents of the study vaccines.'}, 'identificationModule': {'nctId': 'NCT00999206', 'briefTitle': 'Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': "Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.", 'orgStudyIdInfo': {'id': 'S203.3.013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Biological: Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Biological: Influenza Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Biological: Influenza Vaccine']}], 'interventions': [{'name': 'Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'surface antigen, inactivated, prepared in cell cultures', 'armGroupLabels': ['3']}, {'name': 'Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'surface antigen, inactivated, prepared in egg (influvac ®)', 'armGroupLabels': ['4']}, {'name': 'Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'surface antigen, inactivated, prepared in cell cultures', 'armGroupLabels': ['1']}, {'name': 'Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'surface antigen, inactivated, prepared in cell cultures', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44652', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '4066', 'city': 'Auchenflower', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44662', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '2148', 'city': 'Blacktown', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44651', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '2148', 'city': 'Blacktown', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44659', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '2292', 'city': 'Broadmeadow', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44647', 'geoPoint': {'lat': -32.92371, 'lon': 151.72849}}, {'zip': '4510', 'city': 'Caboolture', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44649', 'geoPoint': {'lat': -27.08465, 'lon': 152.9511}}, {'zip': '4152', 'city': 'Carina Heights', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44646', 'geoPoint': {'lat': -27.50721, 'lon': 153.09126}}, {'zip': '4006', 'city': 'Herston', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44650', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '2077', 'city': 'Hornsby', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44663', 'geoPoint': {'lat': -33.70244, 'lon': 151.09931}}, {'zip': '4020', 'city': 'Kippa-Ring', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44645', 'geoPoint': {'lat': -27.22586, 'lon': 153.0835}}, {'zip': '3145', 'city': 'Malvern East', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44644', 'geoPoint': {'lat': -37.87397, 'lon': 145.04253}}, {'zip': '2035', 'city': 'Maroubra Junction', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44648'}, {'zip': '4075', 'city': 'Sherwood', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 44643', 'geoPoint': {'lat': -31.06485, 'lon': 152.72879}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Site Reference ID/Investigator# 44653', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '9012', 'city': 'Dunedin', 'country': 'New Zealand', 'facility': 'Site Reference ID/Investigator# 44658', 'geoPoint': {'lat': -45.87416, 'lon': 170.50361}}, {'zip': '1150', 'city': 'Grafton', 'country': 'New Zealand', 'facility': 'Site Reference ID/Investigator# 44656', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '3010', 'city': 'Rotorua', 'country': 'New Zealand', 'facility': 'Site Reference ID/Investigator# 44655', 'geoPoint': {'lat': -38.13874, 'lon': 176.24516}}, {'zip': '3110', 'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Site Reference ID/Investigator# 44654', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'zip': '6035', 'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Site Reference ID/Investigator# 44657', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'overallOfficials': [{'name': 'Hanka de Voogd, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Healthcare Products B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Biologicals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}