Viewing Study NCT00584194

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Ignite Creation Date: 2025-12-25 @ 1:32 AM
Ignite Modification Date: 2025-12-27 @ 10:51 PM
Study NCT ID: NCT00584194
Status: COMPLETED
Last Update Posted: 2020-01-03
First Post: 2007-12-20
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Immunogenicity Study of Rift Valley Fever Vaccine
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': 'D012295', 'term': 'Rift Valley Fever'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}], 'ancestors': [{'id': 'D006524', 'term': 'Hepatitis, Viral, Animal'}, {'id': 'D006520', 'term': 'Hepatitis, Animal'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D002044', 'term': 'Bunyaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'janice.rusnak@amedd.army.mil', 'phone': '301-619-4156', 'title': 'Janice Rusnak, MD', 'organization': 'USAMRIID Medical Division'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Annuals done for 5 years', 'description': 'Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).', 'eventGroups': [{'id': 'EG000', 'title': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 75, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Headache', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'notes': 'Probably related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sore throat', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sore throat', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sore throat', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Malaise', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Malaise', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Malaise', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myalgia', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myalgia', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinusitis', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinusitis', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinusitis', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bruising', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Congestion', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Congestion', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Congestion', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cough', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cough', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cough', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasal congestion', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasal congestion', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fever', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fever', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinus congestion', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinus congestion', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhea', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stuffy nose', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stuffy nose', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'warm', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fracture', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lacerations', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Axillary tenderness', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Swelling', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dry cough', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dry cough', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Light headedness', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Light headedness', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Low back pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Runny nose', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Runny nose', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Scratchy throat', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal cramping', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Head cold', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Swollen neck glands', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sneezing', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Admittance', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blurred vision', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Concussion', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hives', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stomach ache', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Foggy head', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neck swollen', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bump on right arm', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest congestion', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feeling faint', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stiff neck', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hoarseness', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Loss of appetite', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lymphadenopathy', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tender lymph nodes', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tight chest', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Wheezing', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Flashes of light', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'GI problems', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Knee injury', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Knee pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Absence from work', 'notes': 'No data', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pressure', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinus headache', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stomach virus', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urination discomfort', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear pressure', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchitis', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nail fungus', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper eyelid pain to touch', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper eyelid itchy', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper eyelid swollen', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscle strain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rotator cuff screw removal', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sweating', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bradycardia', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neck pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscle fatigue', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pinkeye', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Migraine', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Itchy bumps on arms', 'notes': 'Probably related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Joint pain', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eye trauma', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abcess', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdomen pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bil umbilial hernias', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Inguinal hernia', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Face swelling', 'notes': 'Unlikely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Elevated B/P', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'URI', 'notes': 'Possibly related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erythema', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erythema', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Induration', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Induration', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tender at site', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bruising', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Warmth at site', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tenderness', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Soreness', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Warm', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Axillary pain', 'notes': 'Probably related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Swelling', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Edema', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ecchymosis', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot at site', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Redness', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Burning and pinching', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tender to touch', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Burning sensation', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain at site', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tingling', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Swelling at site', 'notes': 'Definitely related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Rotator cuff surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cyst exicision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Loss of consciousness during physcial assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Obstructive sleep apnea surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Meniscus repair surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Partial sigmoidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Laproscopic surgery for RLQ pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Left nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety: All Incidences of Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: Geometric Mean Titers After 3rd Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.'}], 'classes': [{'title': 'Male: GMT', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '75.4'}]}]}, {'title': 'Female: GMT', 'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000', 'lowerLimit': '43.6', 'upperLimit': '128.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days after dose 3', 'description': 'Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population is based on responders (defined as a subject achieving a PRNT80 \\>1:40)'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: Geometric Mean Titers Before 6-month Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.'}], 'classes': [{'title': 'Male: GMT', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '15.3'}]}]}, {'title': 'Female: GMT', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '68.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before 6-month booster', 'description': 'Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population is based on responders (defined as a subject achieving a PRNT80 \\>1:40)'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: Geometric Mean Titers at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.'}], 'classes': [{'title': 'Male: GMT', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '118.1'}]}]}, {'title': 'Female: GMT', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000', 'lowerLimit': '23.1', 'upperLimit': '101.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'at 12 months', 'description': 'Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population is based on responders (defined as a subject achieving a PRNT80 \\>1:40)'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: Geometric Mean Titers After 6-month Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.'}], 'classes': [{'title': 'Male: GMT', 'categories': [{'measurements': [{'value': '211.8', 'groupId': 'OG000', 'lowerLimit': '140.5', 'upperLimit': '319.3'}]}]}, {'title': 'Female: GMT', 'categories': [{'measurements': [{'value': '189.0', 'groupId': 'OG000', 'lowerLimit': '128.0', 'upperLimit': '279.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'month 6 after dose 4', 'description': 'Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population is based on responders (defined as a subject achieving a PRNT80 \\>1:40)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '135'}]}]}], 'recruitmentDetails': '278 subjects were enrolled at USAMRIID to participate'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.\n\nTSI-GSD 200 RVF Vaccine: Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "Baseline includes all subjects vaccinated and doesn't account for drop outs, deviations, and withdraws. Demographics weren't given in Final Clinical Study Report. Numbers are reliant on numbers of females and males receiving vaccination."}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2017-02-02', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-30', 'studyFirstSubmitDate': '2007-12-20', 'dispFirstSubmitQcDate': '2017-02-02', 'resultsFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2007-12-31', 'dispFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-16', 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: All Incidences of Erythema', 'timeFrame': '12 months', 'description': 'Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity: Geometric Mean Titers After 3rd Vaccination', 'timeFrame': '28 days after dose 3', 'description': 'Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)'}, {'measure': 'Immunogenicity: Geometric Mean Titers Before 6-month Booster', 'timeFrame': 'Before 6-month booster', 'description': 'Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B'}, {'measure': 'Immunogenicity: Geometric Mean Titers at 12 Months', 'timeFrame': 'at 12 months', 'description': 'Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.'}, {'measure': 'Immunogenicity: Geometric Mean Titers After 6-month Booster', 'timeFrame': 'month 6 after dose 4', 'description': 'Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF'], 'conditions': ['Rift Valley Fever']}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine', 'detailedDescription': 'Study Objectives:\n\nThe objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParts A \\& B:\n\n* At least 18 years old, or if active military duty, 17 years old,\n* Females of childbearing potential must agree to have a urine pregnancy test within 48 hours before receipt of each dose of vaccine. The test results must be negative. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose, and must not be breast-feeding,\n* Subject must be actively enrolled in the SIP to be vaccinated at USAMRIID or be otherwise authorized (with documentation) by the DOD\n* Subjects must be at risk for exposure to RVF virus,\n* Subjects must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in their charts and be medically cleared for participation by an investigator. Examinations or tests may be repeated within 1 year at the discretion of the enrolling physician.\n* Volunteer must have signed and dated the approved informed consent (Volunteer Agreement Explanation and Affidavit).\n\nAdditional Inclusion Criteria for Part B:\n\n• Completion of primary series and any follow-up titer (PRNT80) \\< 1:40 from the current or a previous RVF IND 365 protocol.\n\nExclusion Criteria\n\nParts A \\& B:\n\n* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B or carrier state, or elevated liver function tests.\n* Personal history of immunodeficiency or current treatment with immunosuppressive medication, at the discretion of the physician.\n* Confirmed HIV infection.\n* Any medical condition that, at the discretion of the physician, may jeopardize the safety of the volunteer.\n* Any serious or life-threatening allergies to any component of the vaccine: formalin, human serum albumin, neomycin, streptomycin\n* Administration of any other vaccine within 28 days of any dose of RVF vaccine.\n* Any unresolved adverse event resulting from a previous immunization.\n\nAdditional Exclusion Criteria for Part B:\n\n• An adequate PRNT80 (≥ 1:40) after completion of primary series.'}, 'identificationModule': {'nctId': 'NCT00584194', 'acronym': 'RVF', 'briefTitle': 'Safety and Immunogenicity Study of Rift Valley Fever Vaccine', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study', 'orgStudyIdInfo': {'id': 'A-12592'}, 'secondaryIdInfos': [{'id': 'FY03-05', 'type': 'OTHER', 'domain': 'SIP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TSI-GSD 200 RVF Vaccine', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.', 'interventionNames': ['Biological: TSI-GSD 200 RVF Vaccine']}], 'interventions': [{'name': 'TSI-GSD 200 RVF Vaccine', 'type': 'BIOLOGICAL', 'description': 'Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \\< 1:40.', 'armGroupLabels': ['TSI-GSD 200 RVF Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21702', 'city': 'Fort Deterick', 'state': 'Maryland', 'country': 'United States', 'facility': 'U.S. Army Medical Research Institute of Infectious Diseases', 'geoPoint': {'lat': 39.43538, 'lon': -77.4286}}], 'overallOfficials': [{'name': 'Janice Rusnak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USAMRIID Medical Division'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}