Viewing Study NCT01147068

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Ignite Creation Date: 2025-12-24 @ 5:36 PM
Ignite Modification Date: 2025-12-29 @ 2:21 AM
Study NCT ID: NCT01147068
Status: COMPLETED
Last Update Posted: 2012-11-26
First Post: 2010-06-16
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'D007273', 'term': 'Injections, Intramuscular'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rizikson@proteinsciences.com', 'phone': '203-599-6064', 'title': 'Dr. Ruvim Izikson, M.D.', 'phoneExt': '163', 'organization': 'Protein Sciences Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The absence of a treatment group receiving a SE- or GLA-alone adjuvanted vaccine formulation is a limitation to the study conclusion.'}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events - 28 days following immunization; Serious adverse events, adverse events of special interest, and new onset of chronic illnesses for duration of 12-month follow-up after immunization.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle', 'otherNumAtRisk': 60, 'otherNumAffected': 39, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PanBlok 135µg No Adjuvant', 'description': '135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle', 'otherNumAtRisk': 57, 'otherNumAffected': 36, 'seriousNumAtRisk': 57, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'PanBlok 45µg No Adjuvant', 'description': '45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle', 'otherNumAtRisk': 55, 'otherNumAffected': 33, 'seriousNumAtRisk': 55, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'PanBlok 45µg and GLA 1.0µg, SE 2%', 'description': '45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle', 'otherNumAtRisk': 56, 'otherNumAffected': 35, 'seriousNumAtRisk': 56, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'PanBlok 15µg and GLA 1.0µg, SE 2%', 'description': '15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle', 'otherNumAtRisk': 56, 'otherNumAffected': 40, 'seriousNumAtRisk': 56, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'PanBlok 7.5µg and GLA 1.0µg, SE 2%', 'description': '7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle', 'otherNumAtRisk': 53, 'otherNumAffected': 32, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'PanBlok 3.8µg and GLA 1.0µg, SE 2%', 'description': '3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle', 'otherNumAtRisk': 55, 'otherNumAffected': 38, 'seriousNumAtRisk': 55, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Blood Cholesterol Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Mean Cell Haemoglobin Concentration Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Carbon Dioxide Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gamma-Glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neutrophil Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oropharngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'White Blood Cell Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Lactate Dehydrogenase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Urea Nitrogen/Creatinine Ratio Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haematocrit Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Cholesterol Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haematocrit Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hand Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG001', 'title': 'PanBlok 135µg No Adjuvant', 'description': '135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG002', 'title': 'PanBlok 45µg No Adjuvant', 'description': '45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG003', 'title': 'PanBlok 45µg and GLA 1.0µg, SE 2%', 'description': '45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG004', 'title': 'PanBlok 15µg and GLA 1.0µg, SE 2%', 'description': '15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG005', 'title': 'PanBlok 7.5µg and GLA 1.0µg, SE 2%', 'description': '7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG006', 'title': 'PanBlok 3.8µg and GLA 1.0µg, SE 2%', 'description': '3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '45'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '27'}, {'value': '82', 'groupId': 'OG003', 'lowerLimit': '69', 'upperLimit': '90'}, {'value': '75', 'groupId': 'OG004', 'lowerLimit': '62', 'upperLimit': '84'}, {'value': '66', 'groupId': 'OG005', 'lowerLimit': '53', 'upperLimit': '77'}, {'value': '72', 'groupId': 'OG006', 'lowerLimit': '58', 'upperLimit': '82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '42 Days', 'description': 'Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received study vaccine and had Day 0 and Day 42 efficacy data. The analysis results are generated by Southern Research Institute on the intention to treat efficacy population using whole virus.'}, {'type': 'SECONDARY', 'title': 'Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG001', 'title': 'PanBlok 135µg No Adjuvant', 'description': '135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG002', 'title': 'PanBlok 45µg No Adjuvant', 'description': '45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG003', 'title': 'PanBlok 45µg and GLA 1.0µg, SE 2%', 'description': '45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG004', 'title': 'PanBlok 15µg and GLA 1.0µg, SE 2%', 'description': '15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG005', 'title': 'PanBlok 7.5µg and GLA 1.0µg, SE 2%', 'description': '7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG006', 'title': 'PanBlok 3.8µg and GLA 1.0µg, SE 2%', 'description': '3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Titer was below limit of detection', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Titer was below limit of detection', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Titer was below limit of detection', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Titer was below limit of detection', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Titer was below limit of detection', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Titer was below limit of detection', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Titer was below limit of detection', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Titer was below limit of detection', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '10.7', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '14'}, {'value': '128.4', 'groupId': 'OG003', 'lowerLimit': '93', 'upperLimit': '177'}, {'value': '94.5', 'groupId': 'OG004', 'lowerLimit': '63', 'upperLimit': '142'}, {'value': '68.7', 'groupId': 'OG005', 'lowerLimit': '45', 'upperLimit': '104'}, {'value': '71.7', 'groupId': 'OG006', 'lowerLimit': '47', 'upperLimit': '108'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0, and Day 42', 'description': 'Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received study vaccine and had Day 0 and Day 42 geometric mean titers. Analysis of results were generated by Southern Research Institute on the overall population using whole virus.'}, {'type': 'SECONDARY', 'title': 'Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG001', 'title': 'PanBlok 135µg No Adjuvant', 'description': '135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG002', 'title': 'PanBlok 45µg No Adjuvant', 'description': '45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG003', 'title': 'PanBlok 45µg and GLA 1.0µg, SE 2%', 'description': '45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG004', 'title': 'PanBlok 15µg and GLA 1.0µg, SE 2%', 'description': '15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG005', 'title': 'PanBlok 7.5µg and GLA 1.0µg, SE 2%', 'description': '7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'OG006', 'title': 'PanBlok 3.8µg and GLA 1.0µg, SE 2%', 'description': '3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '12.3'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '12.7'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '21.9'}, {'value': '7', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '17.3'}, {'value': '8', 'groupId': 'OG005', 'lowerLimit': '2.1', 'upperLimit': '18.5'}, {'value': '2', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '9.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 Days', 'description': 'Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized subjects with Day 0 and Day 21 data analyzed by Cincinnati Children's Hospital Medical Center using the intent to treat population and CBER antigen."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'FG001', 'title': 'PanBlok 135µg No Adjuvant', 'description': '135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'FG002', 'title': 'PanBlok 45µg No Adjuvant', 'description': '45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'FG003', 'title': 'PanBlok 45µg and GLA 1.0µg, SE 2%', 'description': '45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'FG004', 'title': 'PanBlok 15µg and GLA 1.0µg, SE 2%', 'description': '15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'FG005', 'title': 'PanBlok 7.5µg and GLA 1.0µg, SE 2%', 'description': '7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'FG006', 'title': 'PanBlok 3.8µg and GLA 1.0µg, SE 2%', 'description': '3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}], 'periods': [{'title': 'Subjects That Received 1st Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Subjects That Received 2nd Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '51'}, {'groupId': 'FG006', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Did not complete the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Subjects That Completed Safety Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants were eligible for follow-up regardless of number of doses received.', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': 'One subject was ineligible, one subject did not complete the study, and the other data is unknown.', 'groupId': 'FG001', 'numSubjects': '57'}, {'comment': 'Data on three subjects is unknown.', 'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'comment': 'Data for one subject is unknown.', 'groupId': 'FG004', 'numSubjects': '56'}, {'comment': 'One subject was lost to follow up and one subject did not complete the study.', 'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '52'}, {'groupId': 'FG006', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy adults 18-49 years of age were screened in participating outpatient clinics for eligibility within 30 days of randomization during the 2010 influenza season.', 'preAssignmentDetails': 'Subjects whose laboratory values were exclusionary were not randomized. Women of child-bearing potential were required to have a negative pregnancy test.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '55', 'groupId': 'BG006'}, {'value': '392', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'BG001', 'title': 'PanBlok 135µg No Adjuvant', 'description': '135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'BG002', 'title': 'PanBlok 45µg No Adjuvant', 'description': '45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'BG003', 'title': 'PanBlok 45µg and GLA 1.0µg, SE 2%', 'description': '45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'BG004', 'title': 'PanBlok 15µg and GLA 1.0µg, SE 2%', 'description': '15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'BG005', 'title': 'PanBlok 7.5µg and GLA 1.0µg, SE 2%', 'description': '7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'BG006', 'title': 'PanBlok 3.8µg and GLA 1.0µg, SE 2%', 'description': '3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart\n\n0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '30.0', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '48'}, {'value': '32.0', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '31.0', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '33.5', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '27.0', 'groupId': 'BG005', 'lowerLimit': '19', 'upperLimit': '48'}, {'value': '33.0', 'groupId': 'BG006', 'lowerLimit': '19', 'upperLimit': '49'}, {'value': '32.2', 'groupId': 'BG007', 'lowerLimit': '18', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'description': 'The median was measured based on the total population of each arm.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '232', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '160', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-24', 'studyFirstSubmitDate': '2010-06-16', 'resultsFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-24', 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.', 'timeFrame': '42 Days', 'description': 'Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.'}], 'secondaryOutcomes': [{'measure': 'Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.', 'timeFrame': 'Day 0, and Day 42', 'description': 'Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.'}, {'measure': 'Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age', 'timeFrame': '21 Days', 'description': 'Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Influenza'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '24075920', 'type': 'DERIVED', 'citation': 'Treanor JJ, Essink B, Hull S, Reed S, Izikson R, Patriarca P, Goldenthal KL, Kohberger R, Dunkle LM. Evaluation of safety and immunogenicity of recombinant influenza hemagglutinin (H5/Indonesia/05/2005) formulated with and without a stable oil-in-water emulsion containing glucopyranosyl-lipid A (SE+GLA) adjuvant. Vaccine. 2013 Nov 19;31(48):5760-5. doi: 10.1016/j.vaccine.2013.08.064. Epub 2013 Sep 27.'}], 'seeAlsoLinks': [{'url': 'http://proteinsciences.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.', 'detailedDescription': "All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.\n\nOne potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18-49 years.\n* Give written informed consent to participate.\n* Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory evaluation\n* Females should fulfill one of the following criteria:\n\n * At least one year post-menopausal;\n * Surgically sterile;\n * Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after the booster vaccination; or\n * Willing to use another reliable form of contraception approved by the Investigator (e.g., intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination and until 28 days after the booster vaccination.\n* Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of first and booster vaccinations\n* Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.\n\nExclusion Criteria:\n\n* Persons under 18 years old or 50 years or older\n* Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease\n* Persons taking medications or treatments that may adversely affect the immune system\n* Persons with known allergy to eggs or other vaccine or adjuvant components\n* Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination\n* Persons who have had a prior serious reaction to any influenza vaccine\n* Persons with a known history of Guillain-Barré Syndrome\n* Persons with a history of anaphylactic-type reaction to injected vaccines\n* Persons with a history of drug or chemical abuse in the year preceding the study\n* Persons who previously received an H5N1 influenza vaccine or who plan to receive an H5N1 influenza vaccine while participating in the study\n* Persons who received a seasonal influenza vaccine six months prior to enrollment (may delay enrollment)\n* Persons who received any other vaccine within one week prior to enrollment (may delay enrollment)\n* Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment)\n* Persons currently participating in another research study involving any study medications (investigational drugs or vaccines).'}, 'identificationModule': {'nctId': 'NCT01147068', 'briefTitle': 'Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Protein Sciences Corporation'}, 'officialTitle': 'A Two-Part Placebo-Controlled Evaluation of the Safety and Immunogenicity of an A/Indonesia/5/05 Recombinant Hemagglutinin Influenza H5N1 Vaccine With and Without Glucopyranosyl Lipid A (GLA-SE) in Healthy Adults 18-49', 'orgStudyIdInfo': {'id': 'PSC22 GLA-SE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PanBlok 135µg No Adjuvant', 'description': '135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart', 'interventionNames': ['Biological: 0.5mL Intramuscular Injection']}, {'type': 'EXPERIMENTAL', 'label': 'PanBlok 45µg No Adjuvant', 'description': '45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart', 'interventionNames': ['Biological: 0.5mL Intramuscular Injection']}, {'type': 'EXPERIMENTAL', 'label': 'PanBlok 45µg and GLA 1.0µg, SE 2%', 'description': '45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart', 'interventionNames': ['Biological: 0.5mL Intramuscular Injection']}, {'type': 'EXPERIMENTAL', 'label': 'PanBlok 15µg and GLA 1.0µg, SE 2%', 'description': '15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart', 'interventionNames': ['Biological: 0.5mL Intramuscular Injection']}, {'type': 'EXPERIMENTAL', 'label': 'PanBlok 7.5µg and GLA 1.0µg, SE 2%', 'description': '7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart', 'interventionNames': ['Biological: 0.5mL Intramuscular Injection']}, {'type': 'EXPERIMENTAL', 'label': 'PanBlok 3.8µg and GLA 1.0µg, SE 2%', 'description': '3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart', 'interventionNames': ['Biological: 0.5mL Intramuscular Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart', 'interventionNames': ['Biological: 0.5mL Intramuscular Injection']}], 'interventions': [{'name': '0.5mL Intramuscular Injection', 'type': 'BIOLOGICAL', 'otherNames': ['rHA', 'recombinant hemagglutinin', 'PanBlok'], 'description': '0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle', 'armGroupLabels': ['PanBlok 135µg No Adjuvant', 'PanBlok 15µg and GLA 1.0µg, SE 2%', 'PanBlok 3.8µg and GLA 1.0µg, SE 2%', 'PanBlok 45µg No Adjuvant', 'PanBlok 45µg and GLA 1.0µg, SE 2%', 'PanBlok 7.5µg and GLA 1.0µg, SE 2%', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'John Treanor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protein Sciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO', 'investigatorFullName': 'Manon M.J. Cox', 'investigatorAffiliation': 'Protein Sciences Corporation'}}}}