Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-12 @ 4:19 AM
Study NCT ID:
NCT02680002
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C089950', 'term': 'MF59 oil emulsion'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Silvija.Tresnjak-Smith@hhs.gov', 'phone': '202-557-1993', 'title': 'Silvija Tresnjak-Smith', 'organization': 'BARDA'}, 'certainAgreement': {'otherDetails': 'Data and results owned by Sponsor. Results can be used by Institution for (a) internal non-commercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Protocol implied Clinical Study Report (CSR) would include Day 386 (end-of-study) data. Following start of study it was decided CSR would include data up to and including Day 201. CSR addendum will include data from Day 201-Day 386.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).', 'description': 'Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.', 'eventGroups': [{'id': 'EG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 44, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 49, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 47, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 57, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 48, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 47, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site pain', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site induration', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site erythema', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Joint dislocation', 'notes': 'Joint dislocation (left hip) determined to be displaced prosthesis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Infected skin ulcer', 'notes': 'Left foot.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cellulitis', 'notes': 'Left foot.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Osteomyelitis', 'notes': 'Left fifth metatarsal.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pseudomeningocele', 'notes': 'Pseudomeningocele diagnosed post-operatively following anterior/posterior cervical fusion with plating, and a C5-6 right hemilaminectomy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'notes': 'Injury resulting from motor vehicle accident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastrointestinal organ contusion', 'notes': 'Injury resulting from motor vehicle accident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rib fracture', 'notes': 'Injury resulting from motor vehicle accident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Flank pain', 'notes': 'Injury resulting from motor vehicle accident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'classes': [{'title': 'Total number solicited local AEs (Adverse Events)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Mild solicited AEs', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Moderate solicited AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Severe solicited AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 to 7', 'description': 'Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1', 'unitOfMeasure': 'occurrences', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received Dose 1 (Day 0), analyzed up to Day 7.'}, {'type': 'PRIMARY', 'title': 'Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'classes': [{'title': 'Total number solicited local AEs (Adverse Events)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Mild solicited AEs', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Moderate solicited AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Severe solicited AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21 to 28', 'description': 'Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2', 'unitOfMeasure': 'occurrences', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received Dose 2 (Day 21), analyzed up to Day 28.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'classes': [{'title': 'Total number solicited local AEs (Adverse Events)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Mild solicited local AEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Moderate solicited local AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Severe solicited local AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 0 to 7', 'description': 'Number of participants with \\>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received Dose 1 (Day 0), analyzed up to Day 7.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'classes': [{'title': 'Total number solicited local AEs (Adverse Events)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Mild solicited local AEs', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Moderate solicited local AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Total no. Severe solicited local AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 21 to 28', 'description': 'Number of participants with \\>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received Dose 2 (Day 21), analyzed up to Day 28.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'classes': [{'title': 'Total no. solicited systemic AEs (Adverse Events)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '40.6'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '36.0'}, {'value': '23', 'groupId': 'OG002', 'lowerLimit': '22.1', 'upperLimit': '45.1'}, {'value': '24', 'groupId': 'OG003', 'lowerLimit': '23.0', 'upperLimit': '46.0'}, {'value': '17', 'groupId': 'OG004', 'lowerLimit': '14.8', 'upperLimit': '36.0'}, {'value': '18', 'groupId': 'OG005', 'lowerLimit': '16.5', 'upperLimit': '38.6'}]}]}, {'title': 'Total no. Mild solicited systemic AEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '29.7'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '31.3'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '14.8', 'upperLimit': '36.0'}, {'value': '19', 'groupId': 'OG003', 'lowerLimit': '16.9', 'upperLimit': '38.6'}, {'value': '13', 'groupId': 'OG004', 'lowerLimit': '10.3', 'upperLimit': '29.7'}, {'value': '13', 'groupId': 'OG005', 'lowerLimit': '10.6', 'upperLimit': '30.5'}]}]}, {'title': 'Total no. Moderate solicited systemic AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '19.5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '12.0'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '17.7'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '13.8'}, {'value': '4', 'groupId': 'OG004', 'lowerLimit': '1.6', 'upperLimit': '14.0'}, {'value': '3', 'groupId': 'OG005', 'lowerLimit': '0.9', 'upperLimit': '12.4'}]}]}, {'title': 'Total no. Severe solicited systemic AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.6'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '0.4', 'upperLimit': '10.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 to 7', 'description': 'Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received Dose 1 (Day 0), analyzed up to Day 7.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'classes': [{'title': 'Total no. solicited systemic AEs (Adverse Events)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '29.1'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '25.4'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '28.3'}, {'value': '17', 'groupId': 'OG003', 'lowerLimit': '15.1', 'upperLimit': '36.5'}, {'value': '9', 'groupId': 'OG004', 'lowerLimit': '6.5', 'upperLimit': '24.7'}, {'value': '9', 'groupId': 'OG005', 'lowerLimit': '6.7', 'upperLimit': '25.4'}]}]}, {'title': 'Total no. Mild solicited systemic AEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '23.5'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '25.4'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '26.5'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '26.7'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '17.0'}, {'value': '9', 'groupId': 'OG005', 'lowerLimit': '6.7', 'upperLimit': '25.4'}]}]}, {'title': 'Total no. Moderate solicited systemic AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '13.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.3'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.3'}, {'value': '6', 'groupId': 'OG003', 'lowerLimit': '3.3', 'upperLimit': '18.0'}, {'value': '4', 'groupId': 'OG004', 'lowerLimit': '1.7', 'upperLimit': '15.0'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Total no. Severe solicited systemic AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21 to 28', 'description': 'Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received Dose 2 (Day 21), analyzed up to Day 28.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without 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(Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 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{'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'Day 28 (Visit 6, +1 day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Day 42 (Visit 7, plus or minus 3 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Day 201 (Visit 8, plus or minus 7 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)', 'description': 'Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who satisfied the predefined criteria for assessment.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'classes': [{'title': 'Visit 4: Day 21 (+1 day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'Visit 6: Day 28 (+1day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Visit 7: Day 42 (plus or minus 3 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Visit 8: Day 201 (plus or minus 7 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 21, 28, 42, and 201', 'description': 'Defined as proportion of subjects achieving either a prevaccination HAI titer of \\<1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI titer of at least 1:10 and a 4-fold or greater increase of HAI postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI titer is undetectable, it will be assigned a vaue of half the lower limit of detection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who satisfied the predefined criteria'}, {'type': 'SECONDARY', 'title': 'Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'OG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'OG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'OG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'OG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'classes': [{'title': 'Visit 4: Day 21 (+1 day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}, {'title': 'Visit 6: Day 28 (+1day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}]}, {'title': 'Visit 7: Day 42 (plus or minus 3 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Visit 8: Day 201 (plus or minus 7 days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 21, 28, 42, and 201', 'description': 'Defined as proportion of subjects achieving either a prevaccination MN titer of \\<1:10 and postvaccination titer of at least 1:40 or a prevaccination MN titer of at least 1:10 and a 4-fold or greater increase of MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who satisfied the predefined criteria'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'FG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant MF59 adjuvant'}, {'id': 'FG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant\n\n7.5 mcg H5N1 (stored as monobulk)\n\nMF59'}, {'id': 'FG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'FG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'FG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '70'}, {'groupId': 'FG005', 'numSubjects': '70'}]}, {'type': 'Day 0 (Dose 1)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '70'}, {'groupId': 'FG005', 'numSubjects': '68'}]}, {'type': 'Day 21 (Dose 2)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '69'}, {'groupId': 'FG004', 'numSubjects': '65'}, {'groupId': 'FG005', 'numSubjects': '63'}]}, {'type': 'Day 201', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Missed Visit 8 (Day 201)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were screened and enrolled at 6 sites in the US.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}, {'value': '419', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant'}, {'id': 'BG001', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant'}, {'id': 'BG002', 'title': '7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'BG003', 'title': '15 mcg H5N1 (Monobulk) Plus MF59 (Vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant'}, {'id': 'BG004', 'title': '90 mcg H5N1 (Monobulk) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59'}, {'id': 'BG005', 'title': '90 mcg H5N1 (Vials) Without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to <30', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '98', 'groupId': 'BG006'}]}]}, {'title': '30 to <40', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '150', 'groupId': 'BG006'}]}]}, {'title': '40 to 49', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '171', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '8.02', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '8.47', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '8.37', 'groupId': 'BG002'}, {'value': '35.7', 'spread': '8.25', 'groupId': 'BG003'}, {'value': '34.9', 'spread': '8.62', 'groupId': 'BG004'}, {'value': '36.0', 'spread': '7.60', 'groupId': 'BG005'}, {'value': '36.4', 'spread': '8.24', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '49'}, {'value': '37.5', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '48'}, {'value': '38.5', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '37.0', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '48'}, {'value': '37.0', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '35.0', 'groupId': 'BG005', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '37', 'groupId': 'BG006', 'lowerLimit': '18', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '249', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '170', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}, {'value': '289', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '116', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}, {'value': '419', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '32.79', 'spread': '9.29', 'groupId': 'BG000'}, {'value': '30.76', 'spread': '8.59', 'groupId': 'BG001'}, {'value': '31.75', 'spread': '8.35', 'groupId': 'BG002'}, {'value': '30.50', 'spread': '8.15', 'groupId': 'BG003'}, {'value': '31.76', 'spread': '8.13', 'groupId': 'BG004'}, {'value': '31.57', 'spread': '9.27', 'groupId': 'BG005'}, {'value': '31.52', 'spread': '8.62', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.93', 'groupId': 'BG000', 'lowerLimit': '20.23', 'upperLimit': '63.66'}, {'value': '28.95', 'groupId': 'BG001', 'lowerLimit': '17.76', 'upperLimit': '61.42'}, {'value': '29.79', 'groupId': 'BG002', 'lowerLimit': '17.50', 'upperLimit': '56.96'}, {'value': '28.08', 'groupId': 'BG003', 'lowerLimit': '13.89', 'upperLimit': '53.45'}, {'value': '30.21', 'groupId': 'BG004', 'lowerLimit': '20.33', 'upperLimit': '54.13'}, {'value': '30.84', 'groupId': 'BG005', 'lowerLimit': '17.89', 'upperLimit': '71.43'}, {'value': '29.70', 'groupId': 'BG006', 'lowerLimit': '17.50', 'upperLimit': '71.43'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Safety Population: Number of participants receiving at least one dose (Dose 1/Day 0) of the investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-14', 'studyFirstSubmitDate': '2016-01-26', 'resultsFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2016-02-08', 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-14', 'studyFirstPostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.', 'timeFrame': 'Days 0 to 7', 'description': 'Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1'}, {'measure': 'Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.', 'timeFrame': 'Days 21 to 28', 'description': 'Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2'}, {'measure': 'Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.', 'timeFrame': 'Days 0 to 7', 'description': 'Number of participants with \\>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1'}, {'measure': 'Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.', 'timeFrame': 'Days 21 to 28', 'description': 'Number of participants with \\>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2'}, {'measure': 'Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.', 'timeFrame': 'Days 0 to 7', 'description': 'Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1'}, {'measure': 'Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.', 'timeFrame': 'Days 21 to 28', 'description': 'Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2'}, {'measure': 'Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody', 'timeFrame': '21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)', 'description': 'Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)', 'timeFrame': 'First vaccination through 13 months', 'description': 'Number of participants with vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal'}, {'measure': 'Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.', 'timeFrame': 'First vaccination through approximately 13 months after first vaccination', 'description': 'Number of participants with adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal.'}, {'measure': 'Number of Participants With Unsolicited Adverse Events (AE)', 'timeFrame': 'Day 0 (Visit 1) through Day 201 (Visit 8)', 'description': 'Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201)'}, {'measure': 'Frequency of Unsolicited Adverse Events (AE)', 'timeFrame': '21 days following each vaccination (Days 0-21, >21 Days)', 'description': 'Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (\\>21 Days)'}, {'measure': 'Occurrence of Clinical Safety Laboratory AEs', 'timeFrame': '7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)', 'description': 'Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination'}, {'measure': 'GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies', 'timeFrame': 'Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)', 'description': 'Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201'}, {'measure': 'GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies', 'timeFrame': 'Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)', 'description': 'GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201'}, {'measure': 'Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40', 'timeFrame': 'Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)', 'description': 'Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen'}, {'measure': 'Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies', 'timeFrame': 'Days 21, 28, 42, and 201', 'description': 'Defined as proportion of subjects achieving either a prevaccination HAI titer of \\<1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI titer of at least 1:10 and a 4-fold or greater increase of HAI postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI titer is undetectable, it will be assigned a vaue of half the lower limit of detection.'}, {'measure': 'Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies', 'timeFrame': 'Days 21, 28, 42, and 201', 'description': 'Defined as proportion of subjects achieving either a prevaccination MN titer of \\<1:10 and postvaccination titer of at least 1:40 or a prevaccination MN titer of at least 1:10 and a 4-fold or greater increase of MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['A/Vietnam/H5N1 Influenza Virus']}, 'referencesModule': {'references': [{'pmid': '30553570', 'type': 'BACKGROUND', 'citation': 'Oshansky CM, Zhou J, Gao Y, Schweinle JE, Biscardi K, DeBeauchamp J, Pavetto C, Wollish A; BRITE Study Coordination Team; Webby RJ, Cioce V, Donis RO, Bright RA. Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). Vaccine. 2019 Jan 14;37(3):435-443. doi: 10.1016/j.vaccine.2018.11.069. Epub 2018 Dec 12.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/30553570', 'label': 'Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.', 'detailedDescription': 'This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored \\>10 years) and adjuvant (ie, stored \\>5 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or nonpregnant female\n* Provide written informed consent prior to study-related procedures\n* Stable health status\n* Access to consistent and reliable means of telephone contact\n* Able to understand and comply with planned study procedures\n* Agree to stay in contact with site, and no plans to move from study area for study duration\n\nExclusion Criteria:\n\n* Allergic to eggs, other vaccine components, or squalene-based adjuvants\n* Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding\n* Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry\n* Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months\n* Have an active neoplastic disease or history of hematologic malignancy\n* Have long term use (≥14 consecutive days) of glucocorticoids (\\>20 mg/day) or high-dose inhaled steroids (\\>800 mcg/day) within preceding 6 months\n* Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis\n* Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years'}, 'identificationModule': {'nctId': 'NCT02680002', 'briefTitle': 'Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant', 'organization': {'class': 'FED', 'fullName': 'Biomedical Advanced Research and Development Authority'}, 'officialTitle': 'Randomized, Double-Blinded, Phase 2 Study to Assess Safety & Immunogenicity of Stored Inactivated Monovalent Influenza A/Vietnam/H5N1 Virus Vaccine Administered Intramuscularly at Different Dose Levels Given With & Without Stored MF59® Adjuvant', 'orgStudyIdInfo': {'id': 'BARDA CSN 15-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long-term as monobulk inactivated', 'interventionNames': ['Biological: 7.5 mcg H5N1 (stored as monobulk)', 'Other: MF59 (stored as monobulk)']}, {'type': 'EXPERIMENTAL', 'label': '15 mcg H5N1 (monobulk) Plus MF59 (monobulk)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long-term as monobulk MF59 adjuvant', 'interventionNames': ['Biological: 15 mcg H5N1 (stored as monobulk)', 'Other: MF59 (stored as monobulk)']}, {'type': 'EXPERIMENTAL', 'label': '7.5 mcg H5N1 (monobulk) Plus MF59 (vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant', 'interventionNames': ['Biological: 7.5 mcg H5N1 (stored as monobulk)', 'Other: MF59']}, {'type': 'EXPERIMENTAL', 'label': '15 mcg H5N1 (monobulk) Plus MF59 (vials)', 'description': 'Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant', 'interventionNames': ['Biological: 15 mcg H5N1 (stored as monobulk)', 'Other: MF59']}, {'type': 'EXPERIMENTAL', 'label': '90 mcg H5N1 (monobulk) without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59', 'interventionNames': ['Biological: 90 mcg H5N1 (stored as monobulk)']}, {'type': 'EXPERIMENTAL', 'label': '90 mcg H5N1 (vials) without MF59', 'description': 'Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59', 'interventionNames': ['Biological: 90 mcg H5N1 (stored in vials)']}], 'interventions': [{'name': '7.5 mcg H5N1 (stored as monobulk)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)', '7.5 mcg H5N1 (monobulk) Plus MF59 (vials)']}, {'name': '15 mcg H5N1 (stored as monobulk)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['15 mcg H5N1 (monobulk) Plus MF59 (monobulk)', '15 mcg H5N1 (monobulk) Plus MF59 (vials)']}, {'name': '90 mcg H5N1 (stored as monobulk)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['90 mcg H5N1 (monobulk) without MF59']}, {'name': '90 mcg H5N1 (stored in vials)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['90 mcg H5N1 (vials) without MF59']}, {'name': 'MF59', 'type': 'OTHER', 'armGroupLabels': ['15 mcg H5N1 (monobulk) Plus MF59 (vials)', '7.5 mcg H5N1 (monobulk) Plus MF59 (vials)']}, {'name': 'MF59 (stored as monobulk)', 'type': 'OTHER', 'armGroupLabels': ['15 mcg H5N1 (monobulk) Plus MF59 (monobulk)', '7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc./Ridge Family Practice', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Johnson County Clin-Trials, Inc.', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Kentucky Researcch Associates, Inc.', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The study results will be posted on publicly available clinical trial registers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomedical Advanced Research and Development Authority', 'class': 'FED'}, 'collaborators': [{'name': 'PPD Development, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}