Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-01-01 @ 4:43 PM
Study NCT ID:
NCT00254995
Status:
COMPLETED
Last Update Posted:
2016-04-19
First Post:
2005-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactus@sanofipasteur.com', 'title': 'Medical Drector', 'organization': 'Sanofi Pasteur Inc'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data surveillance period was from the day of vaccination up to 6 months post-vaccination from the Hospital database.', 'eventGroups': [{'id': 'EG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study', 'otherNumAtRisk': 31558, 'otherNumAffected': 0, 'seriousNumAtRisk': 31561, 'seriousNumAffected': 273}], 'seriousEvents': [{'term': 'Thrombocytopenia (Chronic, Precedes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Idiopathic thrombocytopenic purpura (Precedes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Congenital Anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 12}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Congenital Heart Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sickle Cell Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pectus Excavatum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Febrile Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Delirium Tremens', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatty Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transplant Rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abscess/Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aseptic Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Encephalitis due to Epstein-Barr Virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Viral Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pelvic Inflammatory Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toxic Shock Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Complications of Transplanted Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Foreign Body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Poisoning/Ingestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 38}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diabetes, Type 1 (New Onset)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diabetes, Type 1 (Prior Onset)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Femoral Epiphysiolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Kyphosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Systemic Lupus Erythematosus (New dx, symptoms precede)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Systemic Lupus Erythematosus (Prior onset)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Temporomandibular Joint Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cancer, Cervix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cancer, Melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cancer, Ovarian', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cancer, Pancreatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign lesion NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cancer, R/O Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "Hodgkin's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphocytic Leukemia (Chronic, Precedes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cranial Nerve Palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic Inflammatory Demyelinating Polyneuritis (Prior onset)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epilepsy (Hx of Seizure Disorder, possible seizure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epilepsy (Seizure Event, w/hx of Seizure Disorder)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "Horner's Syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Syncope/LOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pregnancy - Stillborn Delivery post Prolapsed Cord', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 61}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Suicidal Ideation/Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal Calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'End-Stage Renal Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Testicular Torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthma/RAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asphyxiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sleep Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Elective Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Inguinal Hernia/Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tooth disorder (Dental)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Idiopathic Polycystic Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumocystosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31561, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31561', 'groupId': 'OG000'}, {'value': '31065', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.\n\nThe 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.'}], 'classes': [{'title': 'Abdominal pain (ER)', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000'}, {'value': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Febrile illness (ER)', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000'}, {'value': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal Ideation/Attempt (ER)', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 60 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.', 'unitOfMeasure': 'Events per 1,000 person-months', 'reportingStatus': 'POSTED', 'populationDescription': 'All persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31561', 'groupId': 'OG000'}, {'value': '31065', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.'}], 'classes': [{'title': 'Elective procedure (H)', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}, {'value': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Febrile illness (ER)', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Genital pain (ER)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia (ER)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Mononucleosis (ER)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic perforation (H)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (ER)', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}, {'value': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.', 'unitOfMeasure': 'Events per 1,000 person-months', 'reportingStatus': 'POSTED', 'populationDescription': 'All persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21407', 'groupId': 'OG000'}, {'value': '21407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.'}], 'classes': [{'title': 'Adominal pain (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000'}, {'value': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Febrile illness (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000'}, {'value': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal Ideation/Attempt (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 60 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.', 'unitOfMeasure': 'Events per 1,000 person-months', 'reportingStatus': 'POSTED', 'populationDescription': 'All persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21407', 'groupId': 'OG000'}, {'value': '21407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.'}], 'classes': [{'title': 'Diabetes Type 1 (Prior onset)[age 11-16 years; ER]', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty breathing/SOB (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000'}, {'value': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Elective procedure (age 11-16 years; H)', 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000'}, {'value': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Febrile illness (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000'}, {'value': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Hives/Urticaria (age 11-16 years; C)', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000'}, {'value': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Mononucleosis (age 17-18 years; ER)', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Externa (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000'}, {'value': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.', 'unitOfMeasure': 'Events per 1,000 person-months', 'reportingStatus': 'POSTED', 'populationDescription': 'All persons who received Menactra vaccine and their age-matched controls during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31561', 'groupId': 'OG000'}, {'value': '31065', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.'}], 'classes': [{'title': 'Abscess/Cellulitis (ER)', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000'}, {'value': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Allergic reaction (ER)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Allergy, drug (ER)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Benign lesion (H)', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000'}, {'value': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Congenital anomaly (H)', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}, {'value': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Cyst (H)', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000'}, {'value': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue (ER)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Insect bite (ER)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal pain (ER)', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000'}, {'value': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic pain (ER)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Poisoning/Ingestion (H)', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000'}, {'value': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Post-operative complication (ER)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Post-operative complication (H)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy delivery (H)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric (ER)', 'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG000'}, {'value': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric (H)', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000'}, {'value': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Testicular pain (ER)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillitis (H)', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000'}, {'value': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Trauma (ER)', 'categories': [{'measurements': [{'value': '3.77', 'groupId': 'OG000'}, {'value': '5.13', 'groupId': 'OG001'}]}]}, {'title': 'Vision disorder (H)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Well care/Reassurance/Follow-up (ER)', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000'}, {'value': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.', 'unitOfMeasure': 'Events per 1,000 person-months', 'reportingStatus': 'POSTED', 'populationDescription': 'All persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31392', 'groupId': 'OG000'}, {'value': '31065', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.'}], 'classes': [{'title': 'Abdominal pain (age 30-55 years; ER)', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}, {'value': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'Abscess/Cellulitis (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}, {'value': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Allergic reaction (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Benign lesion (age 11-16 years; H)', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000'}, {'value': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Congenital anomaly (age 11-16 years; H)', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000'}, {'value': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Cyst (age 11-16 years; H)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}, {'value': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic pain (age 17-18 years; ER)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Post-operative complication (age 17-18 years; ER)', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000'}, {'value': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric (age 11-16 years; H)', 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000'}, {'value': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric (age 17-18 years; ER)', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000'}, {'value': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric (age 17-18 years; H)', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000'}, {'value': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Testicular pain (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillitis (age 11-16 years; H)', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000'}, {'value': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillitis (age 17-18 years; ER)', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000'}, {'value': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Tonsillitis (age 17-18 years; H)', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}, {'value': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Trauma (age 11-16 years; ER)', 'categories': [{'measurements': [{'value': '3.88', 'groupId': 'OG000'}, {'value': '4.66', 'groupId': 'OG001'}]}]}, {'title': 'Trauma (age 17-18 years; ER)', 'categories': [{'measurements': [{'value': '3.62', 'groupId': 'OG000'}, {'value': '5.27', 'groupId': 'OG001'}]}]}, {'title': 'Trauma (age 19-29 years; ER)', 'categories': [{'measurements': [{'value': '3.53', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Trauma (age 19-29 years; H)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Trauma (age 30-55 years; ER)', 'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000'}, {'value': '9.41', 'groupId': 'OG001'}]}]}, {'title': 'Trauma (age 30-55 years; H)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Well care/Reassurance/Follow-up (age 11-16 yrs;ER)', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000'}, {'value': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Well care/Reassurance/Follow-up (age 17-18 yrs;ER)', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}, {'value': '0.37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.', 'unitOfMeasure': 'Events per 1,000 person-months', 'reportingStatus': 'POSTED', 'populationDescription': 'All persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31561', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.'}], 'classes': [{'title': 'Cardiac arrest', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to 6 months post-vaccination', 'description': 'Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.', 'unitOfMeasure': 'Events per 1,000 doses', 'reportingStatus': 'POSTED', 'populationDescription': 'Only all persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31561', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.'}], 'classes': [{'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Abscess/Cellulitis', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000'}]}]}, {'title': 'Acute renal failure', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Appendicitis', 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Arrhythmia', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Aseptic meningitis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Asphyxiation', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Asthma/Reactive airway disease', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Benign lesion', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'COPD', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Cancer, Cervix', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Cancer, Melanoma', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Cancer, Ovarian', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Cancer, Pancreatic', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Cancer, Rule out cancer', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Cholelithiasis', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Chronic inflammatory demyelinating polyneuritis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Complications of transplanted organ', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Congenital anomaly', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000'}]}]}, {'title': 'Congenital heart disease', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Cranial nerve palsy', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Cyst', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Delirium tremens', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Dental', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes type I (Diagnosed after vaccination)', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes type I (Diagnosed before vaccination)', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Elective procedure', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000'}]}]}, {'title': 'Encephalitis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Encephalitis due to Epstein-Barr virus', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'End-stage renal disease', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Epilepsy (Hx of seizure disorder possible seizure)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Epilepsy (Seizure event, w/hx of seizure disorder)', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Fatty liver', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Febrile illness', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Femoral epiphysiolysis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Foreign body', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Gastroesophageal reflux', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}]}]}, {'title': "Hodgkin's disease", 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': "Horner's syndrome", 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Hydrocephalus', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'ITP (Diagnosed before vaccination)', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Idiopathic polycystic splenomegaly', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Inguinal hernia/repair', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Kyphosis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Labyrinthitis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytic leukemia (Chronic, diagnosed before)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Migraine', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Osteomyelitis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatitis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Pectus excavatum', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Pelvic inflammatory disease', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Pharyngitis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Pneumocystosis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Pneumothorax', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Poisoning/ingestion', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy - Stillborn delivery post prolapsed cord', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric', 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'Plumonary embolism', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory syncytial virus infection', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Renal calculus', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Scoliosis', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Sickle cell disease', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Sleep apnea', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Splenomegaly', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Suicidal ideation/attempt', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Syncope/Loss of consciousness', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'SLE (Diagnosed after vaccination; symptoms before)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'SLE (Diagnosed before vaccination)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Temporomandibular joint disorder', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Testicular torsion', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Thrombocytopenia (Chronic, diagnosed before vacc.)', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Tonsillitis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Toxic shock syndrome', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Transplant rejection', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Trauma', 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Viral syndrome', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to 6 months post-vaccination', 'description': 'Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.', 'unitOfMeasure': 'Events per 1,000 doses', 'reportingStatus': 'POSTED', 'populationDescription': 'Only persons who received Menactra vaccine during the study period were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31561', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.\n\nNone administered in this study: N/A in this study'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.'}], 'classes': [{'title': 'Live births', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Live births with congenital anomaly (facial cyst)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Elective abortion', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Early fetal death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lost to follow up', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Determination of Pregnancy Outcome', 'description': 'Only persons who received Menactra vaccine during the study period were included in this outcome.', 'unitOfMeasure': 'Paticipants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only persons who received Menactra vaccine during the study period were included in the analysis. There were no control group analysis because the threshold of 25 pregnancies with known were not achieved at the time the surveillance was concluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Kaiser Permanente members who received Menactra vaccine during the study period.\n\nKaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.\n\nKaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31561'}, {'groupId': 'FG001', 'numSubjects': '31065'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31561'}, {'groupId': 'FG001', 'numSubjects': '31065'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participant accrual occurred from 15 July 2005 through 14 April 2006.', 'preAssignmentDetails': 'Databases were reviewed to identify persons who received Menactra vaccine within Kaiser Permanente and to identify all medical care events for the 6-month period following vaccination or, if applicable, through the end of pregnancy. Subjects served as their own control for 0-30 days surveillance, age-matched control served for the 6-month period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31561', 'groupId': 'BG000'}, {'value': '31065', 'groupId': 'BG001'}, {'value': '62626', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Menactra Vaccine Recipients', 'description': 'Kaiser Permanente members who received Menactra vaccine during the study period.\n\nKaiser Permanente database was used as no study vaccine was provided or administered as part of this study.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.\n\nKaiser Permanente database was used as no study vaccine was provided or administered as part of this study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '5.56', 'groupId': 'BG000'}, {'value': '15.65', 'spread': '5.56', 'groupId': 'BG001'}, {'value': '15.6', 'spread': '5.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '26805', 'groupId': 'BG000'}, {'value': '26383', 'groupId': 'BG001'}, {'value': '53188', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4732', 'groupId': 'BG000'}, {'value': '4658', 'groupId': 'BG001'}, {'value': '9390', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '15722', 'groupId': 'BG000'}, {'value': '15369', 'groupId': 'BG001'}, {'value': '31091', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '15836', 'groupId': 'BG000'}, {'value': '15696', 'groupId': 'BG001'}, {'value': '31532', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender information for 3 participants was not available in the database.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31561', 'groupId': 'BG000'}, {'value': '31065', 'groupId': 'BG001'}, {'value': '62626', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Seasonality', 'classes': [{'title': 'December - February', 'categories': [{'measurements': [{'value': '4689', 'groupId': 'BG000'}, {'value': '4671', 'groupId': 'BG001'}, {'value': '9360', 'groupId': 'BG002'}]}]}, {'title': 'March - May', 'categories': [{'measurements': [{'value': '3605', 'groupId': 'BG000'}, {'value': '3602', 'groupId': 'BG001'}, {'value': '7207', 'groupId': 'BG002'}]}]}, {'title': 'June - August', 'categories': [{'measurements': [{'value': '17577', 'groupId': 'BG000'}, {'value': '17080', 'groupId': 'BG001'}, {'value': '34657', 'groupId': 'BG002'}]}]}, {'title': 'September - November', 'categories': [{'measurements': [{'value': '5739', 'groupId': 'BG000'}, {'value': '5712', 'groupId': 'BG001'}, {'value': '11451', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Data represents participants receiving vaccine each season or time period shown. Some participants (49) had received more than one dose of Menactra vaccine are counted for each dose in the seasonality section.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects who received Menactra vaccine during the study period from the Kaiser Permanente databases.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62626}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2005-11-15', 'resultsFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2005-11-15', 'lastUpdatePostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-03', 'studyFirstPostDateStruct': {'date': '2005-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance', 'timeFrame': 'Day 0 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.'}, {'measure': 'Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance', 'timeFrame': 'Day 0 up to Day 60 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.'}, {'measure': 'Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance', 'timeFrame': 'Day 0 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.'}, {'measure': 'Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance', 'timeFrame': 'Day 0 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.'}, {'measure': 'Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance', 'timeFrame': 'Day 0 up to Day 180 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.'}, {'measure': 'Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined.', 'timeFrame': 'Day 0 up to 6 months post-vaccination', 'description': 'Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.'}, {'measure': 'Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined', 'timeFrame': 'Day 0 up to 6 months post-vaccination', 'description': 'Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.'}, {'measure': 'Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination', 'timeFrame': 'Day 0 up to Determination of Pregnancy Outcome', 'description': 'Only persons who received Menactra vaccine during the study period were included in this outcome.'}], 'primaryOutcomes': [{'measure': 'Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance', 'timeFrame': 'Day 0 up to Day 60 post-vaccination', 'description': 'Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meningitis', 'Meningococcal disease', 'Menactra vaccine'], 'conditions': ['Meningitis', 'Meningococcal Disease']}, 'referencesModule': {'references': [{'pmid': '28941623', 'type': 'DERIVED', 'citation': 'Hansen J, Zhang L, Klein NP, Robertson CA, Decker MD, Greenberg DP, Bassily E, Baxter R. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. Vaccine. 2017 Dec 14;35(49 Pt B):6879-6884. doi: 10.1016/j.vaccine.2017.09.032. Epub 2017 Sep 21.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Past receipt of Menactra vaccine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receipt of Menactra vaccine during the study period.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00254995', 'briefTitle': 'Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ™)', 'orgStudyIdInfo': {'id': 'MTA30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Menactra Vaccine Recipients', 'description': 'Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente.', 'interventionNames': ['Biological: None administered in this study']}, {'label': 'Age-Matched Control', 'description': 'Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine as part of routine medical care during the same month 1 year earlier in Kaiser Permanente', 'interventionNames': ['Biological: None administered in this study']}], 'interventions': [{'name': 'None administered in this study', 'type': 'BIOLOGICAL', 'description': 'N/A in this study', 'armGroupLabels': ['Age-Matched Control', 'Menactra Vaccine Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}