Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-02-28 @ 7:11 PM
Study NCT ID:
NCT01825200
Status:
COMPLETED
Last Update Posted:
2015-02-18
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
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': 'C528512', 'term': 'FluBlok'}, {'id': 'C000613428', 'term': 'Afluria'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ldunkle@proteinsciences.com', 'phone': '203-599-6064', 'title': 'Lisa M. Dunkle, M.D., Chief Medical Officer', 'phoneExt': '153', 'organization': 'Protein Sciences Corporation'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Rash, urticaria, swelling and edema were self-reported by subjects and most were not observed by investigators. Review by independent experts indicated that 42 of 52 subject-reported events did not represent Type 1 (IgE-mediated) hypersensitivity.'}}, 'adverseEventsModule': {'timeFrame': '30 days following vaccine administration', 'description': 'Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.', 'eventGroups': [{'id': 'EG000', 'title': 'Flublok', 'description': 'Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nFlublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.', 'otherNumAtRisk': 1314, 'otherNumAffected': 20, 'seriousNumAtRisk': 1314, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Afluria', 'description': 'Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nAfluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.', 'otherNumAtRisk': 1313, 'otherNumAffected': 16, 'seriousNumAtRisk': 1313, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Cerebellar Stroke Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alcoholic Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Leg Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Salivary Gland Tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1314, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Common Hypersensitivity Reactions as Measure of Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1314', 'groupId': 'OG000'}, {'value': '1313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok', 'description': 'Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nFlublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.'}, {'id': 'OG001', 'title': 'Afluria', 'description': 'Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nAfluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1314', 'groupId': 'OG000'}, {'value': '1313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok', 'description': 'Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nFlublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.'}, {'id': 'OG001', 'title': 'Afluria', 'description': 'Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nAfluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.'}], 'classes': [{'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Medically-Attended Unsolicited Adverse Events', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Local and Systemic Events Reported as a Measure of Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1314', 'groupId': 'OG000'}, {'value': '1313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok', 'description': 'Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nFlublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.'}, {'id': 'OG001', 'title': 'Afluria', 'description': 'Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nAfluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.'}], 'classes': [{'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 Days', 'description': 'Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1314', 'groupId': 'OG000'}, {'value': '1313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok', 'description': 'Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nFlublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.'}, {'id': 'OG001', 'title': 'Afluria', 'description': 'Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nAfluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Days 0-7', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 Days', 'description': 'Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flublok', 'description': 'Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nFlublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.'}, {'id': 'FG001', 'title': 'Afluria', 'description': 'Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nAfluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1319'}, {'groupId': 'FG001', 'numSubjects': '1321'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1314'}, {'groupId': 'FG001', 'numSubjects': '1314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited at outpatient medical clinics over a period of five weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1314', 'groupId': 'BG000'}, {'value': '1313', 'groupId': 'BG001'}, {'value': '2627', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flublok', 'description': 'Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nFlublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.'}, {'id': 'BG001', 'title': 'Afluria', 'description': 'Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL\n\nAfluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '99'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '93'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '99'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '672', 'groupId': 'BG000'}, {'value': '665', 'groupId': 'BG001'}, {'value': '1337', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '642', 'groupId': 'BG000'}, {'value': '648', 'groupId': 'BG001'}, {'value': '1290', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '730', 'groupId': 'BG000'}, {'value': '725', 'groupId': 'BG001'}, {'value': '1455', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '584', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '1172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1098', 'groupId': 'BG000'}, {'value': '1083', 'groupId': 'BG001'}, {'value': '2181', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1209', 'groupId': 'BG000'}, {'value': '1214', 'groupId': 'BG001'}, {'value': '2423', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1314', 'groupId': 'BG000'}, {'value': '1313', 'groupId': 'BG001'}, {'value': '2627', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The primary analysis population includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-29', 'studyFirstSubmitDate': '2013-03-11', 'resultsFirstSubmitDate': '2014-12-19', 'studyFirstSubmitQcDate': '2013-04-02', 'lastUpdatePostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-29', 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Common Hypersensitivity Reactions as Measure of Safety', 'timeFrame': '30 Days', 'description': 'Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.'}], 'secondaryOutcomes': [{'measure': 'Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration', 'timeFrame': '30 Days', 'description': 'Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration'}, {'measure': 'Number of Participants With Local and Systemic Events Reported as a Measure of Safety', 'timeFrame': '7 Days', 'description': 'Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.'}, {'measure': 'Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety', 'timeFrame': '7 Days', 'description': 'Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '26529070', 'type': 'DERIVED', 'citation': 'Izikson R, Leffell DJ, Bock SA, Patriarca PA, Post P, Dunkle LM, Cox MM. Randomized comparison of the safety of Flublok((R)) versus licensed inactivated influenza vaccine in healthy, medically stable adults >/= 50 years of age. Vaccine. 2015 Nov 27;33(48):6622-8. doi: 10.1016/j.vaccine.2015.10.097. Epub 2015 Nov 1.'}], 'seeAlsoLinks': [{'url': 'http://proteinsciences.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.', 'detailedDescription': 'The Advisory Committee on Immunization Practices (ACIP) recommends that all people aged 6 months and older be immunized to prevent influenza. Currently the only approved influenza vaccine across the entire age group is inactivated influenza vaccine (IIV). A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Additional safety and, ultimately efficacy, data is needed to support use in adults ≥50 years of age, an important age group as adults ≥65 years of age are among those at increased risk of influenza complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ambulatory adults aged 50 years and older\n2. Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate\n3. Able to understand and comply with planned study procedures\n4. Provides written informed consent prior to initiation of any study procedure.\n\nExclusion Criteria:\n\n1. Known contraindication to either study vaccine (see product package inserts)\n2. Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study.\n3. Receipt of any new medication within 30 days prior to enrollment in this study\n4. Plans to participate in any investigation involving an investigational product during this study.\n5. Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.\n6. Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation of clinical data.'}, 'identificationModule': {'nctId': 'NCT01825200', 'briefTitle': 'Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Protein Sciences Corporation'}, 'officialTitle': 'Comparison of the Safety of Flublok® Versus Licensed Inactivated Influenza Vaccine in Healthy, Medically Stable Adults ≥ 50 Years of Age', 'orgStudyIdInfo': {'id': 'PSC11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Flublok', 'description': 'Flublok containing 3x45µg (135µg total) of recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL', 'interventionNames': ['Biological: Flublok']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Afluria', 'description': 'Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL', 'interventionNames': ['Biological: Afluria']}], 'interventions': [{'name': 'Flublok', 'type': 'BIOLOGICAL', 'description': 'A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.', 'armGroupLabels': ['Flublok']}, {'name': 'Afluria', 'type': 'BIOLOGICAL', 'description': 'Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.', 'armGroupLabels': ['Afluria']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704-1152', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Genova Clinical Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of South Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Research Associates, LLC', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '68164', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89104', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Center of Nevada, LLC', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '13901', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'facility': 'Regional Clinical Research', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rapid Medical Research, Inc.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76904', 'city': 'San Angelo', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 31.46377, 'lon': -100.43704}}], 'overallOfficials': [{'name': 'Brandon Essink, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meridian Clinical Research'}, {'name': 'Paul Bradley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meridian Clinical Research'}, {'name': 'William Seger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benchmark Research'}, {'name': 'Darrell Herrington, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benchmark Research'}, {'name': 'George Bauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benchmark Research'}, {'name': 'Frank Eder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional Clinical Research'}, {'name': 'Treva Tyson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Research'}, {'name': 'Bob Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maine Research Associates, LLC'}, {'name': 'Jeffrey Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research of South Florida'}, {'name': 'Joe Blumenau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Across America'}, {'name': 'Steven Folkerth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Center of Nevada, LLC'}, {'name': 'Leah Schmidt, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Genova Clinical Research'}, {'name': 'Eric Sheldon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miami Research Associates'}, {'name': 'Alan C. Wine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rapid Medical Research, Inc.'}, {'name': 'Terry Poling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heartland Research Associates, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protein Sciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}