Viewing Study NCT00800605

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Ignite Creation Date: 2025-12-25 @ 3:18 AM
Ignite Modification Date: 2025-12-26 @ 1:56 AM
Study NCT ID: NCT00800605
Status: COMPLETED
Last Update Posted: 2025-11-24
First Post: 2008-12-01
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'angie.kimbler@resilience.com', 'phone': '386-418-8751', 'title': 'Angie Kimbler', 'organization': 'Alachua Government Services, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection', 'otherNumAtRisk': 3623, 'deathsNumAtRisk': 3623, 'otherNumAffected': 2176, 'seriousNumAtRisk': 3623, 'deathsNumAffected': 2, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection', 'otherNumAtRisk': 3620, 'deathsNumAtRisk': 3620, 'otherNumAffected': 1945, 'seriousNumAtRisk': 3620, 'deathsNumAffected': 0, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Lymph Node Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 26}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 38}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 120}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 212}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 203}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 105}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 359}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 226}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1189}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1004}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1571}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 274}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 837}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 537}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 270}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 273}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unevaluable Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 66}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 11}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 118}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Traumatic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 55}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Body Temperature Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 335}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 217}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1042}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 648}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain In Jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1408}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1292}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 22}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 470}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 476}], 'organSystem': 'Respiratory, 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{'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 2}], 'organSystem': 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'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 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disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngeal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 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3620, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3620, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3623, 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and typing of naso-pharyngeal specimens, with a virus that is antigenically similar to one of the strains contained in the vaccine 21 days to 180 days after the date of vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3619', 'groupId': 'OG000'}, {'value': '3617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'categories': [{'title': 'Influenza Infection A/H1N1', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Influenza Infection A/H3N2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Influenza Infection B', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'No Influenza Infection', 'measurements': [{'value': '3595', 'groupId': 'OG000'}, {'value': '3537', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Number of subjects with influenza infection confirmed by viral culture and typing and/or RT-PCR analysis of naso-pharyngeal specimens that are antigenically similar to the strains contained in the vaccine', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3619', 'groupId': 'OG000'}, {'value': '3617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'categories': [{'title': 'Influenza Infection A/H1N1', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'Influenza Infection A/H3N2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Influenza Infection B', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'No Influenza Infection', 'measurements': [{'value': '3598', 'groupId': 'OG000'}, {'value': '3543', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Number of subjects with influenza infection as confirmed by viral culture and typing of naso-pharyngeal specimens regardless of whether the isolate is antigenically matched to the strains contained in the vaccine', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis'}, {'type': 'SECONDARY', 'title': 'HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3473', 'groupId': 'OG000'}, {'value': '3459', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '194.1', 'groupId': 'OG000', 'lowerLimit': '184.4', 'upperLimit': '204.3'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '18.4'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '299.7', 'groupId': 'OG000', 'lowerLimit': '285.2', 'upperLimit': '314.9'}, {'value': '22.4', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '23.5'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '301.7', 'groupId': 'OG000', 'lowerLimit': '290.5', 'upperLimit': '313.4'}, {'value': '39.3', 'groupId': 'OG001', 'lowerLimit': '37.6', 'upperLimit': '41.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '21 days', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3473', 'groupId': 'OG000'}, {'value': '3459', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '89'}, {'value': '29.8', 'groupId': 'OG001', 'lowerLimit': '28.3', 'upperLimit': '31.4'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '94.1'}, {'value': '38.8', 'groupId': 'OG001', 'lowerLimit': '37.2', 'upperLimit': '40.5'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '97.7'}, {'value': '56.2', 'groupId': 'OG001', 'lowerLimit': '54.5', 'upperLimit': '57.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Analysis'}, {'type': 'SECONDARY', 'title': 'Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3473', 'groupId': 'OG000'}, {'value': '3459', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '11.11', 'groupId': 'OG000', 'lowerLimit': '10.52', 'upperLimit': '11.74'}, {'value': '1.06', 'groupId': 'OG001', 'lowerLimit': '1.04', 'upperLimit': '1.08'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '13.51', 'groupId': 'OG000', 'lowerLimit': '12.85', 'upperLimit': '14.2'}, {'value': '1.01', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1.02'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '7.58', 'groupId': 'OG000', 'lowerLimit': '7.22', 'upperLimit': '7.97'}, {'value': '1.03', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '1.05'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '21 days', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3473', 'groupId': 'OG000'}, {'value': '3459', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '70.4', 'groupId': 'OG000', 'lowerLimit': '68.9', 'upperLimit': '71.9'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.6'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000', 'lowerLimit': '77.7', 'upperLimit': '80.4'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '1.3'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '65.7', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '67.3'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'description': 'Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline or a HIA titer ≥ 40 when there is no detectable HIA titer (HIA titer \\<10) at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3623', 'groupId': 'OG000'}, {'value': '3620', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'title': 'No Reaction', 'categories': [{'measurements': [{'value': '1994', 'groupId': 'OG000'}, {'value': '3309', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '1354', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Total with Reaction', 'categories': [{'measurements': [{'value': '1629', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Number of Subjects With Non-Serious Local Reactions During the Entire Follow-Up Period', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis'}, {'type': 'SECONDARY', 'title': 'Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3623', 'groupId': 'OG000'}, {'value': '3620', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Non-Serious Moderate or Severe Systemic AEs', 'categories': [{'measurements': [{'value': '924', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}]}, {'title': 'Any Non-Serious Systemic AEs', 'categories': [{'measurements': [{'value': '2176', 'groupId': 'OG000'}, {'value': '1945', 'groupId': 'OG001'}]}]}, {'title': 'Non-Serious Moderate or Severe Local AEs', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Non-Serious Local AEs', 'categories': [{'measurements': [{'value': '1629', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis'}, {'type': 'SECONDARY', 'title': 'Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3623', 'groupId': 'OG000'}, {'value': '3620', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'classes': [{'title': 'No Reaction', 'categories': [{'measurements': [{'value': '2312', 'groupId': 'OG000'}, {'value': '2748', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '957', 'groupId': 'OG000'}, {'value': '648', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Total with Reaction', 'categories': [{'measurements': [{'value': '1311', 'groupId': 'OG000'}, {'value': '872', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Number of Subjects With Non-Serious Systemic Reactions During the Entire Follow-Up Period', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3626'}, {'groupId': 'FG001', 'numSubjects': '3624'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3421'}, {'groupId': 'FG001', 'numSubjects': '3415'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '209'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3623', 'groupId': 'BG000'}, {'value': '3620', 'groupId': 'BG001'}, {'value': '7243', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VCIV', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine\n\nVero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Phosphate-buffered saline\n\nPlacebo: Phosphate-buffered saline: Single intramuscular injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '32.1', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '32.1', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1800', 'groupId': 'BG000'}, {'value': '1755', 'groupId': 'BG001'}, {'value': '3555', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1823', 'groupId': 'BG000'}, {'value': '1865', 'groupId': 'BG001'}, {'value': '3688', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '616', 'groupId': 'BG000'}, {'value': '638', 'groupId': 'BG001'}, {'value': '1254', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3007', 'groupId': 'BG000'}, {'value': '2982', 'groupId': 'BG001'}, {'value': '5989', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '771', 'groupId': 'BG000'}, {'value': '741', 'groupId': 'BG001'}, {'value': '1512', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2746', 'groupId': 'BG000'}, {'value': '2784', 'groupId': 'BG001'}, {'value': '5530', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.6', 'spread': '22', 'groupId': 'BG000'}, {'value': '83.3', 'spread': '21.1', 'groupId': 'BG001'}, {'value': '83.5', 'spread': '21.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171.6', 'spread': '10', 'groupId': 'BG000'}, {'value': '171.9', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '171.7', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Analysis Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2009-10-28', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2008-12-01', 'dispFirstSubmitQcDate': '2009-10-28', 'resultsFirstSubmitDate': '2025-10-29', 'studyFirstSubmitQcDate': '2008-12-01', 'dispFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-12', 'studyFirstPostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine', 'timeFrame': '180 days', 'description': 'The number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens, with a virus that is antigenically similar to one of the strains contained in the vaccine 21 days to 180 days after the date of vaccination.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine', 'timeFrame': '180 days', 'description': 'Number of subjects with influenza infection confirmed by viral culture and typing and/or RT-PCR analysis of naso-pharyngeal specimens that are antigenically similar to the strains contained in the vaccine'}, {'measure': 'Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically', 'timeFrame': '180 days', 'description': 'Number of subjects with influenza infection as confirmed by viral culture and typing of naso-pharyngeal specimens regardless of whether the isolate is antigenically matched to the strains contained in the vaccine'}, {'measure': 'HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21', 'timeFrame': '21 days'}, {'measure': 'Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21', 'timeFrame': '21 days'}, {'measure': 'Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline', 'timeFrame': '21 days'}, {'measure': 'Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21', 'timeFrame': '21 days', 'description': 'Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline or a HIA titer ≥ 40 when there is no detectable HIA titer (HIA titer \\<10) at baseline.'}, {'measure': 'Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination', 'timeFrame': '180 days', 'description': 'Number of Subjects With Non-Serious Local Reactions During the Entire Follow-Up Period'}, {'measure': 'Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period', 'timeFrame': '180 days'}, {'measure': 'Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination', 'timeFrame': '180 days', 'description': 'Number of Subjects With Non-Serious Systemic Reactions During the Entire Follow-Up Period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or placebo. Blood will be drawn from all subjects for a determination of hemagglutination inhibition antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects must return to the clinic promptly to have swab samples of their nose and throat taken whenever they feel flu symptoms and all subjects will be monitored for adverse events until Day 180.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has an understanding of the study\n* Subject agrees to study provisions\n* Subject gives written informed consent prior to study entry\n* Subject is accessible by telephone or electronic mail to receive reminders from the study site\n* If female and capable of bearing children, subject has a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agrees to employ adequate birth control measures through the first 60 post-vaccination days.\n\nExclusion Criteria:\n\n* Subject has any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC, 2008a):\n\n * Pregnancy\n * Chronic disorders of the pulmonary or cardiovascular system including asthma (hypertension is not considered a high risk condition)\n * Chronic renal disorders\n * Chronic hepatic disorders\n * Chronic hematological disorders\n * Chronic metabolic disorder (including diabetes mellitus and thyroid disorders)\n * Immunosuppression (including immunosuppression caused by medications, congenital etiologies or HIV)\n * Any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders or other neuromuscular disorders)\n * Residence in nursing home or other chronic care facility that houses persons of any age who have chronic medical conditions\n * Household contact with children aged 0 to 59 months or of someone who is included in the risk categories listed above\n * Employment as a health care worker\n* Subject is unable to lead an independent life as a result of either physical or mental handicap\n* Subject has a history of severe allergic reactions or anaphylaxis (e.g., urticaria or asthma that is clinically severe)\n* Subject has an oral temperature of \\>= 99.5° F (37.5°C) on the day of vaccination in this study. \\[NOTE: A subject meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided that certain requirements \\[in the study protocol\\] are met)\n* Subject has a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating\n* Subject has received a blood transfusion, blood products or immunoglobulins within 90 days of study entry\n* Subject has received a live vaccine within 4 weeks or inactivated or subunit vaccine within 2 weeks of study entry\n* Subject has previously been vaccinated against influenza for the 2008/2009 northern hemisphere influenza season\n* Subject has a functional or surgical asplenia\n* Subject has a known or suspected problem with alcohol or drug abuse;\n* Subject was administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product\n* Subject is a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, spouse/partner, siblings, parents) as well as employees of the investigator'}, 'identificationModule': {'nctId': 'NCT00800605', 'briefTitle': 'Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alachua Government Services, Inc.'}, 'officialTitle': 'Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine to Prevent Culture Confirmed Influenza Infection', 'orgStudyIdInfo': {'id': '720802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Vero cell-derived, trivalent, seasonal influenza vaccine', 'interventionNames': ['Biological: Vero cell-derived, trivalent, seasonal influenza vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Phosphate-buffered saline', 'interventionNames': ['Biological: Placebo: Phosphate-buffered saline']}], 'interventions': [{'name': 'Vero cell-derived, trivalent, seasonal influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'Single intramuscular injection', 'armGroupLabels': ['1']}, {'name': 'Placebo: Phosphate-buffered saline', 'type': 'BIOLOGICAL', 'description': 'Single intramuscular injection', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Quality of Life Medical & Research Center, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Research Foundation', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Benchmark Research San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Radiant Research, Inc', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of South Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pharmax Research Clinic', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research, Inc', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Atlanta', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Radiant Research, Inc - 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