Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 5:14 AM
Study NCT ID:
NCT01439360
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2011-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'D019433', 'term': 'Chickenpox Vaccine'}], 'ancestors': [{'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)', 'eventGroups': [{'id': 'EG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).', 'otherNumAtRisk': 6006, 'otherNumAffected': 3427, 'seriousNumAtRisk': 6006, 'seriousNumAffected': 217}, {'id': 'EG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).', 'otherNumAtRisk': 6012, 'otherNumAffected': 3501, 'seriousNumAtRisk': 6012, 'seriousNumAffected': 201}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1504, 'numAffected': 1230}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1561, 'numAffected': 1293}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1365, 'numAffected': 983}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1467, 'numAffected': 1094}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1734, 'numAffected': 1385}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1808, 'numAffected': 1428}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1050, 'numAffected': 871}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1111, 'numAffected': 943}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1824, 'numAffected': 1351}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1868, 'numAffected': 1376}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 954, 'numAffected': 866}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1042, 'numAffected': 949}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1259, 'numAffected': 1025}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1388, 'numAffected': 1129}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 842, 'numAffected': 665}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 928, 'numAffected': 743}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 629, 'numAffected': 522}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 609, 'numAffected': 516}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascariasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chikungunya virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Escherichia pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis shigella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatitis a', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mycoplasma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 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1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6006, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6012, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy (VE)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '63.2', 'ciLowerLimit': '51.8', 'ciUpperLimit': '72.3', 'estimateComment': 'VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.', 'groupDescription': 'The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (\\>) 25%.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for age category and stratified for cohort.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy (VE)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '49.8', 'ciLowerLimit': '41.8', 'ciUpperLimit': '56.8', 'estimateComment': 'VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.', 'groupDescription': 'The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for age category and stratified for cohort'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '303', 'groupId': 'OG000'}, {'value': '602', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5707', 'groupId': 'OG000'}, {'value': '5697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.'}, {'type': 'SECONDARY', 'title': 'Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'H1N1, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '744', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '13.2'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '13.5'}]}]}, {'title': 'H1N1, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '165.3', 'groupId': 'OG000', 'lowerLimit': '148.6', 'upperLimit': '183.8'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '14.3'}]}]}, {'title': 'H3N2, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '16.5'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '15.2'}]}]}, {'title': 'H3N2, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132.1', 'groupId': 'OG000', 'lowerLimit': '119.1', 'upperLimit': '146.5'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '16.7'}]}]}, {'title': 'Victoria, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '11.0'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '10.1'}]}]}, {'title': 'Victoria, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '750', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000', 'lowerLimit': '82.3', 'upperLimit': '104.1'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '10.1'}]}]}, {'title': 'Yamagata, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '7.8'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '7.9'}]}]}, {'title': 'Yamagata, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121.4', 'groupId': 'OG000', 'lowerLimit': '110.1', 'upperLimit': '133.8'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '8.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 28/56', 'description': 'Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).\n\nPRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'H1N1, PRE', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'H1N1, POST', 'categories': [{'measurements': [{'value': '728', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, PRE', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, POST', 'categories': [{'measurements': [{'value': '740', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, PRE', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, POST', 'categories': [{'measurements': [{'value': '701', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, PRE', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, POST', 'categories': [{'measurements': [{'value': '719', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0 and Day 28/56', 'description': 'A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).\n\nPRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '596', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '513', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Victoria', 'categories': [{'measurements': [{'value': '514', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata', 'categories': [{'measurements': [{'value': '605', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 28/56 (POST)', 'description': 'Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \\< 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus.\n\nPRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '15.3'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '9.8'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.2'}]}]}, {'title': 'Victoria', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '10.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Yamagata', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '18.3'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 28/56 (POST)', 'description': 'MGI also known as the seroconversion factor \\[SCF\\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).\n\nPOST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'H1N1, PRE', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}, {'title': 'H1N1, POST', 'categories': [{'measurements': [{'value': '640', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, PRE', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, POST', 'categories': [{'measurements': [{'value': '612', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, PRE', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, POST', 'categories': [{'measurements': [{'value': '539', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, PRE', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, POST', 'categories': [{'measurements': [{'value': '638', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0 and Day 28/56', 'description': 'Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).\n\nPRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5907', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5899', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1015', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5899', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5899', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '775', 'groupId': 'OG000'}, {'value': '831', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5899', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5899', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '467', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5899', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5757', 'groupId': 'OG000'}, {'value': '5766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '808', 'groupId': 'OG000'}, {'value': '820', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5757', 'groupId': 'OG000'}, {'value': '5766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5757', 'groupId': 'OG000'}, {'value': '5766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '587', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5757', 'groupId': 'OG000'}, {'value': '5766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5757', 'groupId': 'OG000'}, {'value': '5766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5757', 'groupId': 'OG000'}, {'value': '5766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5907', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1350', 'groupId': 'OG000'}, {'value': '1375', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5907', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5907', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '980', 'groupId': 'OG000'}, {'value': '1091', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5907', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5907', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '665', 'groupId': 'OG000'}, {'value': '742', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5907', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. \\>50mm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'Any Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '739', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '490', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '955', 'groupId': 'OG000'}, {'value': '1029', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '617', 'groupId': 'OG000'}, {'value': '669', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '847', 'groupId': 'OG000'}, {'value': '872', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '541', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5898', 'groupId': 'OG000'}, {'value': '5896', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '519', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '324', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '777', 'groupId': 'OG000'}, {'value': '777', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '488', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '652', 'groupId': 'OG000'}, {'value': '681', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '378', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5755', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1024', 'groupId': 'OG000'}, {'value': '1129', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '673', 'groupId': 'OG000'}, {'value': '738', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1383', 'groupId': 'OG000'}, {'value': '1427', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '905', 'groupId': 'OG000'}, {'value': '940', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1227', 'groupId': 'OG000'}, {'value': '1288', 'groupId': 'OG001'}]}]}, {'title': 'Grade3 Loss of appetite,Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite,AcrossDoses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '774', 'groupId': 'OG000'}, {'value': '809', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '659', 'groupId': 'OG000'}, {'value': '732', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5908', 'groupId': 'OG000'}, {'value': '5901', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)', 'description': 'Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Duration of Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1015', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1015', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '808', 'groupId': 'OG000'}, {'value': '820', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '775', 'groupId': 'OG000'}, {'value': '831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '587', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)', 'description': 'Duration was defined as number of days with any grade of local symptoms.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Duration of Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}, {'value': '1029', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}, {'value': '1029', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '777', 'groupId': 'OG000'}, {'value': '777', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '847', 'groupId': 'OG000'}, {'value': '872', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '681', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)', 'description': 'Duration was defined as number of days with any grade of general symptoms.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6006', 'groupId': 'OG000'}, {'value': '6012', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'Any unsolicited AEs', 'categories': [{'measurements': [{'value': '2640', 'groupId': 'OG000'}, {'value': '2679', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 unsolicited AEs', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}, {'title': 'Related unsolicited AEs', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 28-day (Days 0-27) post-vaccination period', 'description': 'Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6006', 'groupId': 'OG000'}, {'value': '6012', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'Any MAVs', 'categories': [{'measurements': [{'value': '3885', 'groupId': 'OG000'}, {'value': '3988', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 MAVs', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Related MAVs', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (approximately 6- 8 months per subject)', 'description': 'MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6006', 'groupId': 'OG000'}, {'value': '6012', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'Any pIMDs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pIMDs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related pIMDs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (approximately 6- 8 months per subject)', 'description': 'pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6006', 'groupId': 'OG000'}, {'value': '6012', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'OG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'classes': [{'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fatal SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (approximately 6- 8 months per subject)', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'FG001', 'title': 'Control', 'description': 'In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6006'}, {'groupId': 'FG001', 'numSubjects': '6012'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5808'}, {'groupId': 'FG001', 'numSubjects': '5804'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '208'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '129'}]}]}], 'preAssignmentDetails': 'Out of the 12046 enrolled subjects, 21 subjects were excluded from all statistical analyses due to an invalid informed consent form (ICF) and 7 subjects did not receive any study vaccine despite being allocated a subject number, hence only 12018 subjects started this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6006', 'groupId': 'BG000'}, {'value': '6012', 'groupId': 'BG001'}, {'value': '12018', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).'}, {'id': 'BG001', 'title': 'Control', 'description': 'In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '21.8', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '21.9', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2933', 'groupId': 'BG000'}, {'value': '2925', 'groupId': 'BG001'}, {'value': '5858', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3073', 'groupId': 'BG000'}, {'value': '3087', 'groupId': 'BG001'}, {'value': '6160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Heritage / African American', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '1062', 'groupId': 'BG000'}, {'value': '1053', 'groupId': 'BG001'}, {'value': '2115', 'groupId': 'BG002'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '1661', 'groupId': 'BG000'}, {'value': '1666', 'groupId': 'BG001'}, {'value': '3327', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1639', 'groupId': 'BG000'}, {'value': '1642', 'groupId': 'BG001'}, {'value': '3281', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic / North African Heritage', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}]}, {'title': 'White - Caucasian / European Heritage', 'categories': [{'measurements': [{'value': '1471', 'groupId': 'BG000'}, {'value': '1482', 'groupId': 'BG001'}, {'value': '2953', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12046}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2015-08-06', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2011-09-21', 'dispFirstSubmitQcDate': '2015-08-06', 'resultsFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2011-09-21', 'dispFirstPostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-16', 'studyFirstPostDateStruct': {'date': '2011-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}, {'measure': 'Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.', 'timeFrame': 'At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}, {'measure': 'Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}, {'measure': 'Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}, {'measure': 'Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}, {'measure': 'Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}, {'measure': 'Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.', 'timeFrame': 'At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}, {'measure': 'Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.', 'timeFrame': 'During the surveillance period (approximately 6 to 8 months)', 'description': 'Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.'}, {'measure': 'Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)', 'timeFrame': 'At Days 0 and 28/56', 'description': 'Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).\n\nPRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects'}, {'measure': 'Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)', 'timeFrame': 'At Day 0 and Day 28/56', 'description': 'A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).\n\nPRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.'}, {'measure': 'Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)', 'timeFrame': 'At Day 28/56 (POST)', 'description': 'Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \\< 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus.\n\nPRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects'}, {'measure': 'Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).', 'timeFrame': 'At Day 28/56 (POST)', 'description': 'MGI also known as the seroconversion factor \\[SCF\\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).\n\nPOST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.'}, {'measure': 'Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)', 'timeFrame': 'At Day 0 and Day 28/56', 'description': 'Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).\n\nPRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.', 'timeFrame': 'During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. \\>50mm.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.', 'timeFrame': 'During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)', 'description': 'Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.'}, {'measure': 'Duration of Solicited Local Symptoms', 'timeFrame': 'During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)', 'description': 'Duration was defined as number of days with any grade of local symptoms.'}, {'measure': 'Duration of Solicited General Symptoms', 'timeFrame': 'During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)', 'description': 'Duration was defined as number of days with any grade of general symptoms.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 28-day (Days 0-27) post-vaccination period', 'description': 'Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)', 'timeFrame': 'During the entire study period (approximately 6- 8 months per subject)', 'description': 'MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).', 'timeFrame': 'During the entire study period (approximately 6- 8 months per subject)', 'description': 'pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.'}, {'measure': 'Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).', 'timeFrame': 'During the entire study period (approximately 6- 8 months per subject)', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.'}]}, 'conditionsModule': {'keywords': ['Vaccine', 'Seasonal Flu', 'Efficacy', 'Children'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '35083365', 'type': 'DERIVED', 'citation': 'Danier J, Callegaro A, Soni J, Carmona A, Kosalaraska P, Rivera L, Friel D, Pu W, Vantomme V, Dbaibo G, Innis BL, Schuind A, Zaman K, Wilson J. Association Between Hemagglutination Inhibition Antibody Titers and Protection Against Reverse-Transcription Polymerase Chain Reaction-Confirmed Influenza Illness in Children 6-35 Months of Age: Statistical Evaluation of a Correlate of Protection. Open Forum Infect Dis. 2021 Sep 25;9(2):ofab477. doi: 10.1093/ofid/ofab477. eCollection 2022 Feb.'}, {'pmid': '31725115', 'type': 'DERIVED', 'citation': 'Dbaibo G, Amanullah A, Claeys C, Izu A, Jain VK, Kosalaraksa P, Rivera L, Soni J, Yanni E, Zaman K, Acosta B, Ariza M, Arroba Basanta ML, Bavdekar A, Carmona A, Cousin L, Danier J, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Gonzales MLA, Hacimustafaoglu M, Hughes SM, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Szymanski H, Ulied A, Woo W, Schuind A, Innis BL; Flu4VEC Study Group. Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial. Pediatr Infect Dis J. 2020 Jan;39(1):e1-e10. doi: 10.1097/INF.0000000000002504.'}, {'pmid': '31306399', 'type': 'DERIVED', 'citation': 'Danier J, Rivera L, Claeys C, Dbaibo G, Jain VK, Kosalaraksa P, Woo W, Yanni E, Zaman K, Acosta B, Amanullah A, Ariza M, Luisa Arroba Basanta M, Bavdekar A, Carmona A, Cousin L, Diaz A, Diez-Domingo J, Cagri Dinleyici E, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Antionette Gonzales L, Hacimustafaoglu M, Hughes SM, Izu A, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Soni J, Szymanski H, Ulied A, Schuind A, Innis BL; Flu4VEC Study Group. Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine. Pediatr Infect Dis J. 2019 Aug;38(8):866-872. doi: 10.1097/INF.0000000000002387.'}, {'pmid': '30325891', 'type': 'DERIVED', 'citation': 'Claeys C, Chandrasekaran V, Garcia-Sicilia J, Prymula R, Diez-Domingo J, Brzostek J, Mares-Bermudez J, Martinon-Torres F, Pollard AJ, Ruzkova R, Carmona Martinez A, Ulied A, Miranda Valdivieso M, Faust SN, Snape MD, Friel D, Ollinger T, Soni J, Schuind A, Li P, Innis BL, Jain VK. Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naive Children. Pediatr Infect Dis J. 2019 Feb;38(2):203-210. doi: 10.1097/INF.0000000000002217.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudydatarequest.com', 'label': 'IPD for this study will be made available via the Clinical Study Data Request site.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.\n* A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.\n* Written informed consent obtained from the parent(s) /LAR(s) of the subject.\n* Subjects in stable health as determined by medical history and clinical examination before entering into the study.\n\nExclusion Criteria:\n\n* Participation in a previous FLU-D-QIV-004 study (115345) cohort.\n* Child in care.\n* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.\n* Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.\n* Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.\n* Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.\n* Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.\n* Any contraindication to intramuscular injection.\n* Acute disease and/or fever at the time of enrolment.\n* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.\n* Additional criteria for children ≥ 12 months of age:\n\n * Prior receipt of any licensed varicella vaccine\\* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.\n\n \\* For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.\n * Any history of hepatitis A or varicella diseases.\n* Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:\n\n * Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.'}, 'identificationModule': {'nctId': 'NCT01439360', 'briefTitle': "An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children", 'orgStudyIdInfo': {'id': '115345'}, 'secondaryIdInfos': [{'id': '2011-000758-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-QIV', 'description': 'Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).', 'interventionNames': ['Biological: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).', 'interventionNames': ['Biological: Havrix Junior', 'Biological: Prevenar 13', 'Biological: Varivax/ProVarivax', 'Biological: Varilrix']}], 'interventions': [{'name': 'Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['D-QIV']}, {'name': 'Havrix Junior', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection administered to subjects aged 12 months or older', 'armGroupLabels': ['Control']}, {'name': 'Prevenar 13', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection administered to subjects less than 12 months of age', 'armGroupLabels': ['Control']}, {'name': 'Varivax/ProVarivax', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection administered to subjects more than 12 months of age', 'armGroupLabels': ['Control']}, {'name': 'Varilrix', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous injection administered to subjects more than 12 months of age', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}, {'zip': '2018', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2800', 'city': 'Mechelen', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 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