Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00344318
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2006-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}, {'id': 'C524362', 'term': 'Tritanrix-HepB vaccine'}, {'id': 'C514867', 'term': 'Hiberix'}], 'ancestors': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}]}}, '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 AEs: Within 4 day (Days 0-3) after each dose and across doses; Unsolicited AEs: Within 31 days (Days 0-30) after each vaccination. SAEs: From study Day 0 until the 6-month extended safety follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 296, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.', 'otherNumAtRisk': 303, 'deathsNumAtRisk': 303, 'otherNumAffected': 300, 'seriousNumAtRisk': 303, 'deathsNumAffected': 0, 'seriousNumAffected': 52}, {'id': 'EG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 95, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 98, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 231, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 152, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 65, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 99, 'numAffected': 64}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 420, 'numAffected': 221}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 360, 'numAffected': 265}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 124, 'numAffected': 67}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 195, 'numAffected': 91}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 590, 'numAffected': 258}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 732, 'numAffected': 289}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 170, 'numAffected': 82}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 221, 'numAffected': 93}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 599, 'numAffected': 258}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 193, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 175, 'numAffected': 82}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 182, 'numAffected': 89}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 543, 'numAffected': 255}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 542, 'numAffected': 262}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 187, 'numAffected': 88}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 155, 'numAffected': 77}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 42, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 43, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 346, 'numAffected': 184}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 547, 'numAffected': 256}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 95, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 173, 'numAffected': 85}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 324, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 467, 'numAffected': 226}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 93, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 160, 'numAffected': 75}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 97, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 31, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Viral rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Double ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ill-defined disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Milk allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Pooled Group', 'description': 'Synflorix 1 Group and Synflorix 2 Group pooled together'}, {'id': 'OG001', 'title': 'Prevenar Pooled Group', 'description': 'Prevenar 1 Group and Prevenar 2 Group pooled together'}], 'classes': [{'title': 'Fever > 39.0°C, post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Fever > 39.0°C, post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Fever > 39.0°C, post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Fever > 39.0°C, across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '4.88', 'groupDescription': 'Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \\>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Standardized asymptotic 95% confidence interval (CI) for the difference \\[Synflorix™ minus Prevenar™\\] in terms of percentages of subjects reporting rectal fever \\>39.0°C after Dose 1 was computed.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '-1.48', 'ciLowerLimit': '-6.05', 'ciUpperLimit': '1.92', 'groupDescription': 'Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \\>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \\[Synflorix™ minus Prevenar™\\] in terms of percentages of subjects reporting rectal fever \\>39.0°C after Dose 2 was computed'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.05', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '6.19', 'groupDescription': 'Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \\>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \\[Synflorix™ minus Prevenar™\\] in terms of percentages of subjects reporting rectal fever \\>39.0°C after Dose 3 was computed.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.13', 'ciLowerLimit': '-2.65', 'ciUpperLimit': '8.01', 'groupDescription': 'Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \\>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Standardized asymptotic 95% confidence interval (CI) for the difference \\[Synflorix™ minus Prevenar™\\] in terms of percentages of subjects reporting rectal fever \\>39.0°C across doses was computed.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4 day (Days 0-3) after each dose and across doses', 'description': 'Fever was measured as rectal temperature. Assessment of occurrences of fever \\> 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. For reasons of safety analysis related to rectal temperature, subjects were pooled to form the Synflorix Pooled Group and Prevenar Group.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.'}, {'id': 'OG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.'}, {'id': 'OG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.'}, {'id': 'OG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.'}], 'classes': [{'title': 'Any Pain, Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Any Pain, Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Any Pain, Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Any Pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4 day (Days 0-3) after each dose and across doses', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.'}, {'id': 'OG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.'}, {'id': 'OG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.'}, {'id': 'OG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.'}], 'classes': [{'title': 'Any Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'G3 Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'REL Drowsiness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'G3 Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'REL Fever, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}, {'title': 'G3 Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'REL Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'G3 Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'REL Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Any Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}, {'title': 'G3 Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'REL Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'G3 Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'REL Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}]}, {'title': 'G3 Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'REL Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'G3 Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'REL Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Any Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'G3 Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'REL Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'G3 Fever, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'REL Fever, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'G3 Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'REL Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'G3 Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'REL Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Any Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'G3 Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'REL Drowsiness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'G3 Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'REL Fever, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}]}, {'title': 'G3 Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'REL Irritability, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss of appetite, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'G3 Loss of appetite, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'REL Loss of appetite, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4-day (Days 0-3) after each dose and across doses', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.'}, {'id': 'OG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.'}, {'id': 'OG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.'}, {'id': 'OG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 31 days (Days 0-30) after each vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.'}, {'id': 'OG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.'}, {'id': 'OG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.'}, {'id': 'OG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.'}, {'id': 'OG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.'}, {'id': 'OG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.'}, {'id': 'OG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.'}, {'id': 'OG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.'}, {'id': 'OG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.'}, {'id': 'OG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.'}], 'classes': [{'title': 'Anti-1 POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.23', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '3.54'}, {'value': '1.04', 'groupId': 'OG001', 'lowerLimit': '0.94', 'upperLimit': '1.15'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.4'}, {'value': '0.03', 'groupId': 'OG003', 'lowerLimit': '0.03', 'upperLimit': '0.03'}]}]}, {'title': 'Anti-4 POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.96', 'groupId': 'OG000', 'lowerLimit': '4.46', 'upperLimit': '5.51'}, {'value': '1.64', 'groupId': 'OG001', 'lowerLimit': '1.49', 'upperLimit': '1.8'}, {'value': '5.68', 'groupId': 'OG002', 'lowerLimit': '4.94', 'upperLimit': '6.53'}, {'value': '2.14', 'groupId': 'OG003', 'lowerLimit': '1.88', 'upperLimit': '2.44'}]}]}, {'title': 'Anti-5 POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.87', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '5.26'}, {'value': '1.62', 'groupId': 'OG001', 'lowerLimit': '1.48', 'upperLimit': '1.78'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.04'}, {'value': '0.03', 'groupId': 'OG003', 'lowerLimit': '0.03', 'upperLimit': '0.03'}]}]}, {'title': 'Anti-6B POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.38'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '0.84'}, {'value': '1.06', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.4'}, {'value': '1.23', 'groupId': 'OG003', 'lowerLimit': '0.96', 'upperLimit': '1.58'}]}]}, {'title': 'Anti-7F POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.84', 'groupId': 'OG000', 'lowerLimit': '4.45', 'upperLimit': '5.27'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '2.45'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.04', 'groupId': 'OG003', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Anti-9V POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.04', 'groupId': 'OG000', 'lowerLimit': '3.66', 'upperLimit': '4.46'}, {'value': '1.51', 'groupId': 'OG001', 'lowerLimit': '1.37', 'upperLimit': '1.66'}, {'value': '5.07', 'groupId': 'OG002', 'lowerLimit': '4.32', 'upperLimit': '5.96'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '2.32', 'upperLimit': '3.14'}]}]}, {'title': 'Anti-14 POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.45', 'groupId': 'OG000', 'lowerLimit': '5.65', 'upperLimit': '7.38'}, {'value': '3.31', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '3.68'}, {'value': '5.88', 'groupId': 'OG002', 'lowerLimit': '4.71', 'upperLimit': '7.34'}, {'value': '5.23', 'groupId': 'OG003', 'lowerLimit': '4.39', 'upperLimit': '6.24'}]}]}, {'title': 'Anti-18C POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.56', 'groupId': 'OG000', 'lowerLimit': '10.22', 'upperLimit': '13.08'}, {'value': '3.74', 'groupId': 'OG001', 'lowerLimit': '3.28', 'upperLimit': '4.28'}, {'value': '3.71', 'groupId': 'OG002', 'lowerLimit': '3.14', 'upperLimit': '4.38'}, {'value': '2.64', 'groupId': 'OG003', 'lowerLimit': '2.25', 'upperLimit': '3.11'}]}]}, {'title': 'Anti-19F POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.46', 'groupId': 'OG000', 'lowerLimit': '9.32', 'upperLimit': '11.74'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.77', 'upperLimit': '5.89'}, {'value': '4.68', 'groupId': 'OG002', 'lowerLimit': '4.02', 'upperLimit': '5.45'}, {'value': '2.38', 'groupId': 'OG003', 'lowerLimit': '2.04', 'upperLimit': '2.78'}]}]}, {'title': 'Anti-23F POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.23', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '2.5'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '0.98', 'upperLimit': '1.26'}, {'value': '2.28', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '3.06'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '1.83', 'upperLimit': '2.65'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Seropositivity status, defined as 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This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.'}, {'id': 'FG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.'}, {'id': 'FG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.'}, {'id': 'FG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '303'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '298'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '806', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.'}, {'id': 'BG001', 'title': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.'}, {'id': 'BG002', 'title': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.'}, {'id': 'BG003', 'title': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '1.64', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '7.4', 'spread': '1.53', 'groupId': 'BG002'}, {'value': '7.5', 'spread': '1.55', 'groupId': 'BG003'}, {'value': '7.45', 'spread': '1.56', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '381', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '425', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 806}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2007-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2006-06-23', 'resultsFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2006-06-23', 'lastUpdatePostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-16', 'studyFirstPostDateStruct': {'date': '2006-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)', 'timeFrame': 'Within 4 day (Days 0-3) after each dose and across doses', 'description': 'Fever was measured as rectal temperature. Assessment of occurrences of fever \\> 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms', 'timeFrame': 'Within 4 day (Days 0-3) after each dose and across doses', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'Within 4-day (Days 0-3) after each dose and across doses', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 31 days (Days 0-30) after each vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Serious Adverse (SAEs)', 'timeFrame': 'During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).'}, {'measure': 'Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.'}, {'measure': 'Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.'}, {'measure': 'Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8'}, {'measure': 'Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F ≥ 8.'}, {'measure': 'Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).'}, {'measure': 'Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination.'}, {'measure': 'Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8'}, {'measure': 'Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8'}, {'measure': 'Concentrations of Antibodies Against Protein D (Anti-PD)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL)'}, {'measure': 'Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™', 'description': 'Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects.'}, {'measure': 'Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects.'}, {'measure': 'Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects.'}, {'measure': 'Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Seroprotection status, defined as Anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL'}, {'measure': 'Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects.'}, {'measure': 'Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL'}, {'measure': 'Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects.'}, {'measure': 'Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL'}, {'measure': 'Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Titers were expressed as geometric mean titres (GMTs).'}, {'measure': 'Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8'}, {'measure': 'Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity)', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination.'}, {'measure': 'Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Seropositivity status, defined as Anti-BPT antibody concentrations ≥ 15 EL.U/mL.'}, {'measure': 'Number of Subjects With Vaccine Response to Bordetella Pertussis', 'timeFrame': 'One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™', 'description': 'Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations \\< 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL).'}]}, 'conditionsModule': {'keywords': ['Immunogenicity', 'Safety', 'Pneumococcal vaccine', 'Pneumococcal disease'], 'conditions': ['Infections, Streptococcal']}, 'referencesModule': {'availIpds': [{'id': '107007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '19325452', 'type': 'DERIVED', 'citation': 'Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.'}, {'pmid': '19325451', 'type': 'DERIVED', 'citation': 'Bermal N, Szenborn L, Chrobot A, Alberto E, Lommel P, Gatchalian S, Dieussaert I, Schuerman L. The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) coadministered with DTPw-HBV/Hib and poliovirus vaccines: assessment of immunogenicity. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S89-96. doi: 10.1097/INF.0b013e318199f901.'}, {'pmid': '19325447', 'type': 'DERIVED', 'citation': 'Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.\n\nThe study has 2 groups.\n\n* One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).\n* The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.\n\nAll children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives \\& outcome measures of the primary study. The objectives \\& outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).", 'detailedDescription': 'The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.\n* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol\n* Written informed consent obtained from the parent or guardian of the subject.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* Born after a gestation period between 36 and 42 weeks.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.\n* Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations\n* History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.\n* Acute disease at the time of enrolment\n* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or serious chronic illness.\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.'}, 'identificationModule': {'nctId': 'NCT00344318', 'briefTitle': "Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "To Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age", 'orgStudyIdInfo': {'id': '107007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synflorix 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.', 'interventionNames': ['Biological: Pneumococcal conjugate vaccine GSK1024850A', 'Biological: Tritanrix-HepB', 'Biological: Hiberix', 'Biological: Polio Sabin.', 'Biological: Poliorix.']}, {'type': 'EXPERIMENTAL', 'label': 'Synflorix 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.', 'interventionNames': ['Biological: Pneumococcal conjugate vaccine GSK1024850A', 'Biological: Tritanrix-HepB', 'Biological: Hiberix', 'Biological: Polio Sabin.', 'Biological: Poliorix.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevenar 1 Group', 'description': 'Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.', 'interventionNames': ['Biological: Prevenar', 'Biological: Tritanrix-HepB', 'Biological: Hiberix', 'Biological: Polio Sabin.', 'Biological: Poliorix.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevenar 2 Group', 'description': 'Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.', 'interventionNames': ['Biological: Prevenar', 'Biological: Tritanrix-HepB', 'Biological: Hiberix', 'Biological: Polio Sabin.', 'Biological: Poliorix.']}], 'interventions': [{'name': 'Pneumococcal conjugate vaccine GSK1024850A', 'type': 'BIOLOGICAL', 'description': '3 Intramuscular injections.', 'armGroupLabels': ['Synflorix 1 Group', 'Synflorix 2 Group']}, {'name': 'Prevenar', 'type': 'BIOLOGICAL', 'description': '3 Intramuscular injections', 'armGroupLabels': ['Prevenar 1 Group', 'Prevenar 2 Group']}, {'name': 'Tritanrix-HepB', 'type': 'BIOLOGICAL', 'otherNames': ['DTPw-HBV'], 'description': '3 Intramuscular injections', 'armGroupLabels': ['Prevenar 1 Group', 'Prevenar 2 Group', 'Synflorix 1 Group', 'Synflorix 2 Group']}, {'name': 'Hiberix', 'type': 'BIOLOGICAL', 'otherNames': ['Hib'], 'description': 'Reconstituted with Tritanrix before injection', 'armGroupLabels': ['Prevenar 1 Group', 'Prevenar 2 Group', 'Synflorix 1 Group', 'Synflorix 2 Group']}, {'name': 'Polio Sabin.', 'type': 'BIOLOGICAL', 'otherNames': ['OPV'], 'description': '3 oral doses.', 'armGroupLabels': ['Prevenar 1 Group', 'Prevenar 2 Group', 'Synflorix 1 Group', 'Synflorix 2 Group']}, {'name': 'Poliorix.', 'type': 'BIOLOGICAL', 'otherNames': ['IPV'], 'description': '3 intramuscular injections', 'armGroupLabels': ['Prevenar 1 Group', 'Prevenar 2 Group', 'Synflorix 1 Group', 'Synflorix 2 Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1781', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'zip': '80-394', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '91-347', 'city': 'Lodz', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '55-100', 'city': 'Trzebnica', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.31076, 'lon': 17.06331}}, {'zip': '89-500', 'city': 'Tuchola', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.58792, 'lon': 17.85905}}, {'zip': '50345', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '52-312', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}