Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00586469
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2007-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)', 'description': "For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.", 'eventGroups': [{'id': 'EG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material', 'otherNumAtRisk': 500, 'deathsNumAtRisk': 500, 'otherNumAffected': 271, 'seriousNumAtRisk': 500, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material', 'otherNumAtRisk': 500, 'deathsNumAtRisk': 500, 'otherNumAffected': 290, 'seriousNumAtRisk': 500, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 271}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 290}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 97}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 113}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 101}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint pain at other location', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 138}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Red eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Anti-H3 and B Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'title': 'Anti-H3N2 antibody GMT', 'categories': [{'measurements': [{'value': '369.6', 'groupId': 'OG000', 'lowerLimit': '323.4', 'upperLimit': '422.4'}, {'value': '331.2', 'groupId': 'OG001', 'lowerLimit': '288.8', 'upperLimit': '379.7'}]}]}, {'title': 'Anti-B antibody GMT', 'categories': [{'measurements': [{'value': '269.6', 'groupId': 'OG000', 'lowerLimit': '241.6', 'upperLimit': '300.9'}, {'value': '245.0', 'groupId': 'OG001', 'lowerLimit': '216.7', 'upperLimit': '276.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21', 'description': 'GMTs for H1 strain is addressed as a secondary endpoint', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'title': 'Anti-H1N1 antibody GMT at Day 0 (n=297, 292)', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '17.4'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '18.1'}]}]}, {'title': 'Anti-H1N1 antibody GMT at Day 21 (n=298, 291)', 'categories': [{'measurements': [{'value': '188.1', 'groupId': 'OG000', 'lowerLimit': '163.6', 'upperLimit': '216.4'}, {'value': '169.9', 'groupId': 'OG001', 'lowerLimit': '147.3', 'upperLimit': '196.1'}]}]}, {'title': 'Anti-H3N2 antibody GMT at Day 0 (n=297, 292)', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '25.8', 'upperLimit': '35.9'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '30.1', 'upperLimit': '42.3'}]}]}, {'title': 'Anti-B antibody GMT at Day 0 (n=297, 292)', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '25.3', 'upperLimit': '33.9'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '34.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 21', 'description': 'The table contains GMTs of the H1 strains at Day 0 \\& 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Seroconverted.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'title': 'Anti-H1N1', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}]}, {'title': 'Anti-H3N2', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}, {'title': 'Anti-B', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 21.', 'description': 'The table shows the number of participants who have either a pre-vaccination titer \\< 1:10 and a post-vaccination titer \\>= 1:40 or a prevaccination titer \\>= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Participants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'title': 'Anti-H1N1 at Day 0 (n=297, 292)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Anti-H1N1 at Day 21 (n=298, 291)', 'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}]}, {'title': 'Anti-H3N2 at Day 0 (n=297, 292)', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Anti-H3N2 at Day 21 (n=298, 291)', 'categories': [{'measurements': [{'value': '293', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}]}, {'title': 'Anti-B antibody GMT at Day 0 (n=297, 292)', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}]}, {'title': 'Anti-B antibody GMT at Day21 (n=298, 291)', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Days 0 and 21', 'description': 'The table presents the number of participants with a serum haemagglutination inhibition (HI) titer \\>= 1:40 that usually is accepted as indicating protection.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 21 compared to Day 0', 'description': 'Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.', 'unitOfMeasure': 'Factor', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'title': 'Anti-H3N2', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Anti-B', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 21 compared to Day 0', 'description': 'The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table. The "fold increase" corresponds to the Unit of Measure "Factor."', 'unitOfMeasure': 'Factor', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day follow up period following vaccination.', 'description': 'Solicited local symptoms assessed include pain, redness and swelling.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'title': 'Bronchospasm', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Axillary fever >= 37.5° Celsius (C)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Joint pain at other location', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Muscle aches', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}]}, {'title': 'Red eyes', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Swelling of the face', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day period following each vaccination.', 'description': 'Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Unsolicited Adverse Events (AE).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 21-day period following each vaccination.', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'OG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'classes': [{'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Fatal SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 21 days after vaccination', 'description': 'An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'FG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '500'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '499'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1000', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Old Bulk', 'description': 'This group received a full dose of Fluviral made from aged bulk material'}, {'id': 'BG001', 'title': 'New Bulk', 'description': 'This group received a full dose of Fluviral made from new material'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '12.08', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '12.01', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '12.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '576', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2008-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2009-01-14', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-06', 'studyFirstPostDateStruct': {'date': '2008-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Anti-H3 and B Strains', 'timeFrame': 'At Day 21', 'description': 'GMTs for H1 strain is addressed as a secondary endpoint'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains', 'timeFrame': 'At Days 0 and 21', 'description': 'The table contains GMTs of the H1 strains at Day 0 \\& 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)'}, {'measure': 'Number of Participants Who Seroconverted.', 'timeFrame': 'At Day 21.', 'description': 'The table shows the number of participants who have either a pre-vaccination titer \\< 1:10 and a post-vaccination titer \\>= 1:40 or a prevaccination titer \\>= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.'}, {'measure': 'Number of Seroprotected Participants.', 'timeFrame': 'At Days 0 and 21', 'description': 'The table presents the number of participants with a serum haemagglutination inhibition (HI) titer \\>= 1:40 that usually is accepted as indicating protection.'}, {'measure': 'Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1', 'timeFrame': 'At Day 21 compared to Day 0', 'description': 'Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.'}, {'measure': 'The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B', 'timeFrame': 'At Day 21 compared to Day 0', 'description': 'The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table. The "fold increase" corresponds to the Unit of Measure "Factor."'}, {'measure': 'Number of Participants Reporting Solicited Local Symptoms', 'timeFrame': 'During the 4-day follow up period following vaccination.', 'description': 'Solicited local symptoms assessed include pain, redness and swelling.'}, {'measure': 'Number of Participants Reporting Solicited General Symptoms', 'timeFrame': 'During the 4-day period following each vaccination.', 'description': 'Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face'}, {'measure': 'Number of Participants Reporting Unsolicited Adverse Events (AE).', 'timeFrame': 'During the 21-day period following each vaccination.', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAE)', 'timeFrame': 'Within 21 days after vaccination', 'description': 'An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.'}]}, 'conditionsModule': {'keywords': ['Influenza'], 'conditions': ['Influenza Vaccines']}, 'referencesModule': {'availIpds': [{'id': '111258', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111258', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111258', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111258', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111258', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111258', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111258', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.\n\nOnce a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.\n\nBulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.\n* Male and female adults, 18 to 60 years.\n* Written informed consent obtained from the subject.\n* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.\n\nExclusion Criteria:\n\n* Acute disease at the time of enrollment.\n* Any confirmed or suspected immunosuppressive condition\n* Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.\n* A history of any demyelinating disease including Guillain-Barré syndrome.\n* Presence of an active neurological disorder.\n* Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.\n* Receipt of an influenza vaccine within 6 months prior to study enrollment.\n* Administration of any vaccines within 30 days prior to study enrollment or during the study period.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.\n* Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.\n* A history of severe adverse reaction to a previous influenza vaccination.\n* Lactating/nursing female.\n* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.'}, 'identificationModule': {'nctId': 'NCT00586469', 'briefTitle': 'A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years', 'orgStudyIdInfo': {'id': '111258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Old Bulk', 'description': 'This group receives a full dose of Fluviral made from aged bulk material', 'interventionNames': ['Biological: Fluviral']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'New Bulk', 'description': 'This group receives a full dose of Fluviral made from new material', 'interventionNames': ['Biological: Fluviral']}], 'interventions': [{'name': 'Fluviral', 'type': 'BIOLOGICAL', 'description': 'One dose, Intramuscular injection', 'armGroupLabels': ['New Bulk', 'Old Bulk']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3K 3P4', 'city': 'Coquitlam', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'zip': 'A0A 1G0', 'city': 'Bay Roberts', 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.59989, 'lon': -53.26478}}, {'zip': 'M1L 4S4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK 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'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}