Viewing Study NCT00806195

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Ignite Creation Date: 2025-12-24 @ 2:12 PM
Ignite Modification Date: 2025-12-27 @ 11:47 AM
Study NCT ID: NCT00806195
Status: COMPLETED
Last Update Posted: 2013-07-09
First Post: 2008-12-09
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'Taiwan']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D011054', 'term': 'Poliovirus Vaccine, Inactivated'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022362', 'term': 'Hepatitis A Vaccines'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D015164', 'term': 'Vaccines, Inactivated'}, {'id': 'D023321', 'term': 'Poliovirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout study period.', 'description': 'Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.', 'eventGroups': [{'id': 'EG000', 'title': 'MenACWY-CRM197 + Routine Vaccines (All)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nAll (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.', 'otherNumAtRisk': 5760, 'otherNumAffected': 4701, 'seriousNumAtRisk': 5760, 'seriousNumAffected': 354}, {'id': 'EG001', 'title': 'Routine Vaccines (All)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nAll (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.', 'otherNumAtRisk': 1968, 'otherNumAffected': 1600, 'seriousNumAtRisk': 1968, 'seriousNumAffected': 114}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 276}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 94}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 732}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 234}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 275}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 98}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1181}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 356}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 294}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 106}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 500}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 155}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 519}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 241}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 284}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 181}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 916}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 338}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1146}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 405}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1239}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 373}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 826}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 299}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 446}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 153}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Croup Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 284}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 98}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 524}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 179}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 415}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 124}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 751}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 239}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1579}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 551}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis Media Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 412}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 154}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 609}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 208}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 296}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 93}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2358}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 842}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 591}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 175}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 859}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 277}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 927}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 307}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eating Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 593}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 187}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 504}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 171}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis Diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 628}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 201}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 399}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 145}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 307}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 109}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Idiopathic Thrombocytopenic Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mesenteric Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anomalous Pulmonary Venous Connection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'cMedDRA'}, {'term': 'Congenital Absence Of Bile Ducts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Congenital Aplastic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Craniosynostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cryptorchism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hamartoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRAc'}, {'term': 'Mitochondrial Enzyme Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteognesis Imperfecta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Patent Ductus Arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyloric Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitello-Intestinal Duct Remnant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal Hernia, Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 3}], 'organSystem': 'General disorders', 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[{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary Tract Infection Enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Accidental Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Craniocerebral Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Electrical Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foreign Body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post Procedural Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skull Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Electrocardiogram Qt Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Failure To Thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Feeding Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolic Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute Disseminated Encephalomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myoclonic Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breath Holding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vesicoureteric Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Balanitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Scrotal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenoidal Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchial Hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Status Asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis Atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hernia Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal Hernia Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Kawasaki's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meningitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5760, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1968, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.'}, {'id': 'OG001', 'title': 'Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '6.4', 'groupDescription': 'MenACWY-CRM 197 administered concomitantly with routine vaccines was considered noninferior to routine vaccines alone with respect to severe systemic reactions if the upper limit of the 2-sided 95% CI of the difference (MenACWY-CRM197 vaccine plus routine vaccines group minus routine vaccines only group) in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days (days 1-7) after any vaccination was \\<6%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The null hypothesis associated with the safety objective was that the upper limit of the two-sided 95% CI for this difference in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days after any vaccination (PMenACWY+Routine Vaccines-PRoutine Vaccines) was ≥ 6%.'}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age', 'description': 'To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age.\n\nDetailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.', 'unitOfMeasure': 'Percentages of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on As Treated Safety Population - Subjects who received at least one study dose and provided postbaseline safety data, and that subjects would be included in the group for the vaccination actually received (i.e., analyzed as treated).'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5760', 'groupId': 'OG000'}, {'value': '1968', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 + Routine Vaccines (All)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nAll (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.'}, {'id': 'OG001', 'title': 'Routine Vaccines (All)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nAll (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.5', 'groupDescription': 'MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \\<5%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was ≥5%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.3', 'groupDescription': 'MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \\<5%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was \\<5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (2 months of age) to 18 months of age', 'description': 'To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.', 'unitOfMeasure': 'Percentages of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on as treated safety population.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1313', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM 197 + Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.'}, {'id': 'OG001', 'title': 'Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.'}], 'classes': [{'title': 'Any Local (2 month vaccination) (N=1313, 451)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Tenderness (N=1301, 446)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema (N=1297, 445)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Induration (N=1297, 446)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Any Local (4 month vaccination) (N=1262, 420)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Tenderness (N=1255, 418)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema (N=1257, 417)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Induration (N=1257, 417)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Any Local (6 month vaccination) (N=1120, 374)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Tenderness (N=1106, 372)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema (N=1104, 370)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Induration (N=1107, 370)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Any Local (12 month vaccination) (N=1102, 355)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Tenderness (N=1098, 353)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema (N=1095, 349)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Induration (N=1095, 351)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Any Systemic (2 month vaccination) (N=1313, 451)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Rash (N=1296, 446)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Change in Eating Habits (N=1289, 446)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness (N=1297, 447)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Persistent crying (N=1299,46)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (N=1300, 446)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (N=1298, 446)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea (N=1299, 446)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Fever ( ≥ 38°C) (N=1297, 446)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Analges.Antipyr.Meds (N=1302, 448)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Any Systemic (4 month vaccination) (N=1262, 420)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Rash (N=1253, 416)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Change in Eating Habits (N=1245, 414)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness (N=1253, 416)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Persistent Crying (N=1254, 417)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (N=1254, 416)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (N=1254, 416)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea (N=1255, 416)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Fever ( ≥ 38°C) (N=1251, 416)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Analges.Antipyr.Meds (N=1254, 416)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Any Systemic (6 month vaccination) (N=1120, 374)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Rash (N=1101, 367)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Change in Eating Habits (N=1094, 367)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness (N=1104, 367)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Persistent Crying (N=1103, 368)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (N=1104, 369)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (N=1106, 369)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea (N=1102, 369)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Fever ( ≥ 38°C) (N=1108, 368)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Analges.Antipyr.Meds (N=1103, 370)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Any Systemic (12 month vaccination) (N=1102, 355)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Rash (N=1093, 353)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Change in Eating Habits (N=1089, 348)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness (N=1096, 353)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Persistent Crying (N=1094, 353)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (N=1094, 354)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (N=1094, 353)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea (N=1094, 353)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Fever ( ≥ 38°C) (N=1092, 353)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Analges.Antipyr.Meds (N=1095, 354)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes to Day 7', 'description': 'To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.', 'unitOfMeasure': 'percentages of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on as treated safety population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5760', 'groupId': 'OG000'}, {'value': '1968', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 + Routine Vaccines (All)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nAll (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs.'}, {'id': 'OG001', 'title': 'Routine Vaccines (All)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nAll (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '4848', 'groupId': 'OG000'}, {'value': '1659', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE-Total', 'categories': [{'measurements': [{'value': '354', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Possibly or Probably Related AEs', 'categories': [{'measurements': [{'value': '520', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Premature Withdrawals', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (2 months of age) to 18 months of age', 'description': 'Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on as treated safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MenACWY-CRM197 + Routine Vaccines (Non-detailed)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nNon-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE).'}, {'id': 'FG001', 'title': 'Routine Vaccines (Non-detailed)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nNon-Detailed - subjects who only provided SAEs and medically attended AEs.'}, {'id': 'FG002', 'title': 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.'}, {'id': 'FG003', 'title': 'Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4363'}, {'groupId': 'FG001', 'numSubjects': '1483'}, {'groupId': 'FG002', 'numSubjects': '1409'}, {'groupId': 'FG003', 'numSubjects': '489'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3849'}, {'groupId': 'FG001', 'numSubjects': '1321'}, {'groupId': 'FG002', 'numSubjects': '1139'}, {'groupId': 'FG003', 'numSubjects': '383'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '514'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '270'}, {'groupId': 'FG003', 'numSubjects': '106'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '76'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'Inappropriate Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Administrative Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'All subjects enrolled were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4363', 'groupId': 'BG000'}, {'value': '1483', 'groupId': 'BG001'}, {'value': '1409', 'groupId': 'BG002'}, {'value': '489', 'groupId': 'BG003'}, {'value': '7744', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MenACWY-CRM197 + Routine Vaccines (Non-Detailed)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nNon-Detailed - subjects who only provided SAEs and medically attended AEs.'}, {'id': 'BG001', 'title': 'Routine Vaccines (Non-Detailed)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nNon-Detailed - subjects who only provided SAEs and medically attended AEs.'}, {'id': 'BG002', 'title': 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.'}, {'id': 'BG003', 'title': 'Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '65.5', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '65.2', 'spread': '6.3', 'groupId': 'BG003'}, {'value': '65.0', 'spread': '7.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2135', 'groupId': 'BG000'}, {'value': '703', 'groupId': 'BG001'}, {'value': '716', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '3786', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2228', 'groupId': 'BG000'}, {'value': '780', 'groupId': 'BG001'}, {'value': '693', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}, {'value': '3958', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7744}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'dispFirstSubmitDate': '2011-05-30', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2008-12-09', 'dispFirstSubmitQcDate': '2011-05-30', 'resultsFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2008-12-09', 'dispFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-13', 'studyFirstPostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination', 'timeFrame': '15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age', 'description': 'To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age.\n\nDetailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.'}], 'secondaryOutcomes': [{'measure': 'Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period', 'timeFrame': 'Day 1 (2 months of age) to 18 months of age', 'description': 'To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.'}, {'measure': 'Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination', 'timeFrame': '15 minutes to Day 7', 'description': 'To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.'}, {'measure': 'Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination', 'timeFrame': 'Day 1 (2 months of age) to 18 months of age', 'description': 'Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.'}]}, 'conditionsModule': {'keywords': ['vaccine', 'infants', 'healthy', 'meningitis', 'meningococcal'], 'conditions': ['Meningitis', 'Meningococcal Infection']}, 'descriptionModule': {'briefSummary': 'The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '89 Days', 'minimumAge': '55 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg\n* for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;\n* who are available for all visits scheduled in the study;\n* who are in good health as determined by medical history and physical assessment.\n\nExclusion Criteria:\n\n* who previously received any meningococcal vaccine or D, T, P, IPV or OPV, H influenzae type b (Hib) or Pneumococcus; prior doses of BCG (one) and/or HBV (two) are permitted\n* who have a previous confirmed or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping);\n* who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection at any time since birth;\n* who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;\n* who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥ 38.0°C \\[100.4°F\\]) within the previous 3 days;\n* who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);\n* who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):\n\n 1. receipt of any immunosuppressive therapy at any time since birth\n 2. receipt of immunostimulants at any time since birth\n 3. receipt of any systemic corticosteroid since birth;\n* who have a suspected or known HIV infection or HIV related disease;\n* who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;\n* who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;\n* who have any history of seizure;\n* who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period;\n* who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;\n* who have received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.\n* who are relatives of site research staff working on this study."}, 'identificationModule': {'nctId': 'NCT00806195', 'briefTitle': 'Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants', 'orgStudyIdInfo': {'id': 'V59P23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM197 + Routine Vaccines (Non-Detailed)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nNon-Detailed - infants who only provided SAEs (Serious Adverse Events) and medically attended AEs (Adverse Events).', 'interventionNames': ['Biological: MenACWY-CRM197', 'Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine', 'Biological: Hib (Haemophilus influenza b) Vaccine', 'Biological: IPV (Inactivated Polio Vaccine) Vaccine', 'Biological: Pneumococcal conjugate Vaccine', 'Biological: MMR (Measles, Mumps, and Rubella) Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Vaccines (Non-Detailed)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nNon-Detailed - subjects who only provided SAEs and medically attended AEs.', 'interventionNames': ['Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine', 'Biological: Hib (Haemophilus influenza b) Vaccine', 'Biological: IPV (Inactivated Polio Vaccine) Vaccine', 'Biological: Pneumococcal conjugate Vaccine', 'Biological: MMR (Measles, Mumps, and Rubella) Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.', 'interventionNames': ['Biological: MenACWY-CRM197', 'Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine', 'Biological: Hib (Haemophilus influenza b) Vaccine', 'Biological: IPV (Inactivated Polio Vaccine) Vaccine', 'Biological: Pneumococcal conjugate Vaccine', 'Biological: MMR (Measles, Mumps, and Rubella) Vaccine', 'Biological: Varicella Vaccine', 'Biological: Hepatitis A Virus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Vaccines (Detailed)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nDetailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.', 'interventionNames': ['Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine', 'Biological: Hib (Haemophilus influenza b) Vaccine', 'Biological: IPV (Inactivated Polio Vaccine) Vaccine', 'Biological: Pneumococcal conjugate Vaccine', 'Biological: MMR (Measles, Mumps, and Rubella) Vaccine', 'Biological: Varicella Vaccine', 'Biological: Hepatitis A Virus']}, {'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM197 + Routine Vaccines (All)', 'description': 'Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nAll (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.', 'interventionNames': ['Biological: MenACWY-CRM197', 'Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine', 'Biological: Hib (Haemophilus influenza b) Vaccine', 'Biological: IPV (Inactivated Polio Vaccine) Vaccine', 'Biological: Pneumococcal conjugate Vaccine', 'Biological: MMR (Measles, Mumps, and Rubella) Vaccine', 'Biological: Varicella Vaccine', 'Biological: Hepatitis A Virus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Vaccines (All)', 'description': 'Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.\n\nRoutine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.\n\nAll (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.', 'interventionNames': ['Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine', 'Biological: Hib (Haemophilus influenza b) Vaccine', 'Biological: IPV (Inactivated Polio Vaccine) Vaccine', 'Biological: Pneumococcal conjugate Vaccine', 'Biological: MMR (Measles, Mumps, and Rubella) Vaccine', 'Biological: Varicella Vaccine', 'Biological: Hepatitis A Virus']}], 'interventions': [{'name': 'MenACWY-CRM197', 'type': 'BIOLOGICAL', 'description': 'Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.', 'armGroupLabels': ['MenACWY-CRM197 + Routine Vaccines (All)', 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'MenACWY-CRM197 + Routine Vaccines (Non-Detailed)']}, {'name': 'DTaP (Diptheria, Tetanus, Pertussis) Vaccine', 'type': 'BIOLOGICAL', 'description': 'Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.', 'armGroupLabels': ['MenACWY-CRM197 + Routine Vaccines (All)', 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'MenACWY-CRM197 + Routine Vaccines (Non-Detailed)', 'Routine Vaccines (All)', 'Routine Vaccines (Detailed)', 'Routine Vaccines (Non-Detailed)']}, {'name': 'Hib (Haemophilus influenza b) Vaccine', 'type': 'BIOLOGICAL', 'description': 'Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.', 'armGroupLabels': ['MenACWY-CRM197 + Routine Vaccines (All)', 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'MenACWY-CRM197 + Routine Vaccines (Non-Detailed)', 'Routine Vaccines (All)', 'Routine Vaccines (Detailed)', 'Routine Vaccines (Non-Detailed)']}, {'name': 'IPV (Inactivated Polio Vaccine) Vaccine', 'type': 'BIOLOGICAL', 'description': 'Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.', 'armGroupLabels': ['MenACWY-CRM197 + Routine Vaccines (All)', 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'MenACWY-CRM197 + Routine Vaccines (Non-Detailed)', 'Routine Vaccines (All)', 'Routine Vaccines (Detailed)', 'Routine Vaccines (Non-Detailed)']}, {'name': 'Pneumococcal conjugate Vaccine', 'type': 'BIOLOGICAL', 'description': 'Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.', 'armGroupLabels': ['MenACWY-CRM197 + Routine Vaccines (All)', 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'MenACWY-CRM197 + Routine Vaccines (Non-Detailed)', 'Routine Vaccines (All)', 'Routine Vaccines (Detailed)', 'Routine Vaccines (Non-Detailed)']}, {'name': 'MMR (Measles, Mumps, and Rubella) Vaccine', 'type': 'BIOLOGICAL', 'description': 'One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.', 'armGroupLabels': ['MenACWY-CRM197 + Routine Vaccines (All)', 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'MenACWY-CRM197 + Routine Vaccines (Non-Detailed)', 'Routine Vaccines (All)', 'Routine Vaccines (Detailed)', 'Routine Vaccines (Non-Detailed)']}, {'name': 'Varicella Vaccine', 'type': 'BIOLOGICAL', 'description': 'One vaccination of Varicella vaccine was administered at 12 months of age.', 'armGroupLabels': ['MenACWY-CRM197 + Routine Vaccines (All)', 'MenACWY-CRM197 + Routine Vaccines (Detailed)', 'Routine Vaccines (All)', 'Routine Vaccines (Detailed)']}, {'name': 'Hepatitis A Virus', 'type': 'BIOLOGICAL', 'description': 'One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.', 'armGroupLabels': ['MenACWY-CRM197 + Routine Vaccines (All)', 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