Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT00652951
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2008-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal 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': 'C547294', 'term': 'PHiD-CV vaccine'}, {'id': 'C541234', 'term': 'diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine'}, {'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}], '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 local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).', 'eventGroups': [{'id': 'EG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 260, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 260, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 260, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 326, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 309, 'numAffected': 174}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 342, 'numAffected': 191}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 546, 'numAffected': 231}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 528, 'numAffected': 210}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 542, 'numAffected': 222}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 676, 'numAffected': 252}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 659, 'numAffected': 242}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 649, 'numAffected': 247}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 573, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 527, 'numAffected': 219}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 464, 'numAffected': 208}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 364, 'numAffected': 195}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 297, 'numAffected': 179}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 275, 'numAffected': 164}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 598, 'numAffected': 240}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 544, 'numAffected': 237}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 553, 'numAffected': 225}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 610, 'numAffected': 232}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 559, 'numAffected': 220}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 516, 'numAffected': 211}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 153, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 160, 'numAffected': 125}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 170, 'numAffected': 133}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Velo-cardio-facial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coeliac disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Adhesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Enterovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis adenovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia primary atypical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Greenstick fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Feeding disorder neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Apparent life threatening event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.33'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '1.16', 'upperLimit': '1.48'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.03'}]}]}, {'title': 'Anti-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.61', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '1.84'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '1.38', 'upperLimit': '1.83'}, {'value': '2.44', 'groupId': 'OG002', 'lowerLimit': '2.19', 'upperLimit': '2.73'}]}]}, {'title': 'Anti-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': '2.37'}, {'value': '2.16', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '2.43'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.03'}]}]}, {'title': 'Anti-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.4'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0.28', 'upperLimit': '0.43'}, {'value': '0.41', 'groupId': 'OG002', 'lowerLimit': '0.34', 'upperLimit': '0.51'}]}]}, {'title': 'Anti-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.52', 'upperLimit': '1.9'}, {'value': '1.77', 'groupId': 'OG001', 'lowerLimit': '1.57', 'upperLimit': '1.99'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Anti-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.63'}, {'value': '1.47', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '1.68'}, {'value': '2.14', 'groupId': 'OG002', 'lowerLimit': '1.91', 'upperLimit': '2.4'}]}]}, {'title': 'Anti-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.38', 'groupId': 'OG000', 'lowerLimit': '2.99', 'upperLimit': '3.81'}, {'value': '3.33', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '3.78'}, {'value': '3.64', 'groupId': 'OG002', 'lowerLimit': '3.24', 'upperLimit': '4.1'}]}]}, {'title': 'Anti-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '2.05'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.25'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.83', 'upperLimit': '2.4'}]}]}, {'title': 'Anti-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.07', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '2.48'}, {'value': '1.96', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '2.34'}, {'value': '3.04', 'groupId': 'OG002', 'lowerLimit': '2.71', 'upperLimit': '3.42'}]}]}, {'title': 'Anti-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.6'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.66'}, {'value': '1.24', 'groupId': 'OG002', 'lowerLimit': '1.04', 'upperLimit': '1.47'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.07', 'groupDescription': 'The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% confidence interval (CI) of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 1.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.23', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 4.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.15', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.26', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 6B.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.13', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel Group groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group Group), was lower than 2 for the pneumococcal vaccine serotype 7F.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.16', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 9V.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.21', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 14.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.03', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over ), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 18C.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.36', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 19F.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.23', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa Group and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 23F.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine', 'description': 'Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'PRIMARY', 'title': 'Antibody Concentration Against Protein D (PD) - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'categories': [{'measurements': [{'value': '1580', 'groupId': 'OG000', 'lowerLimit': '1409.5', 'upperLimit': '1771.1'}, {'value': '1743', 'groupId': 'OG001', 'lowerLimit': '1560.2', 'upperLimit': '1947.2'}, {'value': '69.7', 'groupId': 'OG002', 'lowerLimit': '63', 'upperLimit': '77.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.06', 'groupDescription': 'The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for protein D.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine', 'description': 'Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Anti-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}]}, {'title': 'Anti-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}]}, {'title': 'Anti-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Anti-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}]}, {'title': 'Anti-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}]}, {'title': 'Anti-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}]}, {'title': 'Anti-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Opsono-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': '27.6'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '27.4'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '5.2'}]}]}, {'title': 'Opsono-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '592.9', 'groupId': 'OG000', 'lowerLimit': '475.9', 'upperLimit': '738.7'}, {'value': '600.4', 'groupId': 'OG001', 'lowerLimit': '492.2', 'upperLimit': '732.3'}, {'value': '838.4', 'groupId': 'OG002', 'lowerLimit': '718.7', 'upperLimit': '978.2'}]}]}, {'title': 'Opsono-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '68.4'}, {'value': '60.1', 'groupId': 'OG001', 'lowerLimit': '48.2', 'upperLimit': '74.8'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '4.6'}]}]}, {'title': 'Opsono-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '261.3', 'groupId': 'OG000', 'lowerLimit': '176', 'upperLimit': '388'}, {'value': '296.4', 'groupId': 'OG001', 'lowerLimit': '198', 'upperLimit': '443.7'}, {'value': '633', 'groupId': 'OG002', 'lowerLimit': '419', 'upperLimit': '956.4'}]}]}, {'title': 'Opsono-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2063.3', 'groupId': 'OG000', 'lowerLimit': '1691.7', 'upperLimit': '2516.6'}, {'value': '2136.1', 'groupId': 'OG001', 'lowerLimit': '1707.9', 'upperLimit': '2671.5'}, {'value': '18.4', 'groupId': 'OG002', 'lowerLimit': '12.1', 'upperLimit': '28'}]}]}, {'title': 'Opsono-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '863.6', 'groupId': 'OG000', 'lowerLimit': '687.6', 'upperLimit': '1084.7'}, {'value': '1277.7', 'groupId': 'OG001', 'lowerLimit': '1053.3', 'upperLimit': '1550.1'}, {'value': '1194', 'groupId': 'OG002', 'lowerLimit': '1009.5', 'upperLimit': '1412.1'}]}]}, {'title': 'Opsono-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '990.4', 'groupId': 'OG000', 'lowerLimit': '820.6', 'upperLimit': '1195.5'}, {'value': '1086.4', 'groupId': 'OG001', 'lowerLimit': '899.6', 'upperLimit': '1311.9'}, {'value': '1373.3', 'groupId': 'OG002', 'lowerLimit': '1040.4', 'upperLimit': '1812.7'}]}]}, {'title': 'Opsono-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '122.6', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '168.2'}, {'value': '84.2', 'groupId': 'OG001', 'lowerLimit': '60.9', 'upperLimit': '116.5'}, {'value': '213.6', 'groupId': 'OG002', 'lowerLimit': '163.6', 'upperLimit': '278.8'}]}]}, {'title': 'Opsono-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '180.2'}, {'value': '143.8', 'groupId': 'OG001', 'lowerLimit': '108.6', 'upperLimit': '190.3'}, {'value': '39.2', 'groupId': 'OG002', 'lowerLimit': '30.6', 'upperLimit': '50.4'}]}]}, {'title': 'Opsono-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '847.4', 'groupId': 'OG000', 'lowerLimit': '626.5', 'upperLimit': '1146.3'}, {'value': '1089', 'groupId': 'OG001', 'lowerLimit': '800.2', 'upperLimit': '1482'}, {'value': '3703.4', 'groupId': 'OG002', 'lowerLimit': '3119.4', 'upperLimit': '4396.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.12'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.12'}, {'value': '0.08', 'groupId': 'OG002', 'lowerLimit': '0.06', 'upperLimit': '0.09'}]}]}, {'title': 'Anti-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.13'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.11'}, {'value': '0.08', 'groupId': 'OG002', 'lowerLimit': '0.07', 'upperLimit': '0.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Opsono-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '33.6'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '17.1', 'upperLimit': '37.8'}, {'value': '33', 'groupId': 'OG002', 'lowerLimit': '21.4', 'upperLimit': '50.8'}]}]}, {'title': 'Opsono-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '11.7'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '10.2'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '5.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-diphteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.475', 'groupId': 'OG000', 'lowerLimit': '1.307', 'upperLimit': '1.664'}, {'value': '1.078', 'groupId': 'OG001', 'lowerLimit': '0.939', 'upperLimit': '1.237'}, {'value': '1.077', 'groupId': 'OG002', 'lowerLimit': '0.949', 'upperLimit': '1.222'}]}]}, {'title': 'Anti-tetanus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.873', 'groupId': 'OG000', 'lowerLimit': '2.622', 'upperLimit': '3.147'}, {'value': '1.702', 'groupId': 'OG001', 'lowerLimit': '1.528', 'upperLimit': '1.897'}, {'value': '0.934', 'groupId': 'OG002', 'lowerLimit': '0.837', 'upperLimit': '1.043'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.139', 'groupId': 'OG000', 'lowerLimit': '1.766', 'upperLimit': '2.59'}, {'value': '4.796', 'groupId': 'OG001', 'lowerLimit': '3.829', 'upperLimit': '6.007'}, {'value': '2.219', 'groupId': 'OG002', 'lowerLimit': '1.724', 'upperLimit': '2.857'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '39.1', 'upperLimit': '46.6'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '33.4', 'upperLimit': '39.8'}, {'value': '40.1', 'groupId': 'OG002', 'lowerLimit': '37', 'upperLimit': '43.6'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '145.6', 'groupId': 'OG000', 'lowerLimit': '130.4', 'upperLimit': '162.5'}, {'value': '100.8', 'groupId': 'OG001', 'lowerLimit': '89.6', 'upperLimit': '113.5'}, {'value': '100.5', 'groupId': 'OG002', 'lowerLimit': '89.9', 'upperLimit': '112.4'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '109.7'}, {'value': '40.1', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '46.1'}, {'value': '45.1', 'groupId': 'OG002', 'lowerLimit': '39.3', 'upperLimit': '51.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'categories': [{'measurements': [{'value': '356.9', 'groupId': 'OG000', 'lowerLimit': '279.4', 'upperLimit': '455.8'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '16.9'}, {'value': '11.5', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '13.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \\> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \\> 100 mIU/mL or CLIA concentration \\> 10 mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '21.7', 'upperLimit': '34.1'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '19.7'}, {'value': '18.1', 'groupId': 'OG002', 'lowerLimit': '14.8', 'upperLimit': '22.1'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '47.4'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '36.6'}, {'value': '23.2', 'groupId': 'OG002', 'lowerLimit': '18.5', 'upperLimit': '29.1'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '62.4'}, {'value': '34.2', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '43.4'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '21.5', 'upperLimit': '33'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-1, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Anti-4, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}]}, {'title': 'Anti-5, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6B, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Anti-7F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Anti-9V, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}]}, {'title': 'Anti-14, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}]}, {'title': 'Anti-18C, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}]}, {'title': 'Anti-23F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}]}, {'title': 'Anti-1, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Anti-4, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}]}, {'title': 'Anti-5, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6B, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}]}, {'title': 'Anti-7F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Anti-9V, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}]}, {'title': 'Anti-14, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}]}, {'title': 'Anti-18C, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}]}, {'title': 'Anti-23F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to (Month 9) and one month after the administration of the booster dose (Month 10)', 'description': 'Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-1, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.22'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '0.26'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Anti-4, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '0.34', 'upperLimit': '0.46'}, {'value': '0.43', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.5'}, {'value': '0.38', 'groupId': 'OG002', 'lowerLimit': '0.34', 'upperLimit': '0.43'}]}]}, {'title': 'Anti-5, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '0.36', 'upperLimit': '0.47'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.48'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Anti-6B, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.36'}, {'value': '0.32', 'groupId': 'OG001', 'lowerLimit': '0.27', 'upperLimit': '0.38'}, {'value': '0.13', 'groupId': 'OG002', 'lowerLimit': '0.11', 'upperLimit': '0.16'}]}]}, {'title': 'Anti-7F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.68'}, {'value': '0.62', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '0.71'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.03'}]}]}, {'title': 'Anti-9V, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '0.78'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '0.89'}, {'value': '0.55', 'groupId': 'OG002', 'lowerLimit': '0.49', 'upperLimit': '0.62'}]}]}, {'title': 'Anti-14, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.26'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '0.95', 'upperLimit': '1.36'}, {'value': '1.55', 'groupId': 'OG002', 'lowerLimit': '1.35', 'upperLimit': '1.79'}]}]}, {'title': 'Anti-18C, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.68'}, {'value': '0.43', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.5'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '0.35', 'upperLimit': '0.45'}]}]}, {'title': 'Anti-19F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.99'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '1.11'}, {'value': '0.31', 'groupId': 'OG002', 'lowerLimit': '0.25', 'upperLimit': '0.37'}]}]}, {'title': 'Anti-23F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '0.39'}, {'value': '0.38', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '0.46'}, {'value': '0.26', 'groupId': 'OG002', 'lowerLimit': '0.22', 'upperLimit': '0.3'}]}]}, {'title': 'Anti-1, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.16', 'groupId': 'OG000', 'lowerLimit': '1.89', 'upperLimit': '2.46'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2.19', 'upperLimit': '2.89'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Anti-4, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.04', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '3.42'}, {'value': '3.29', 'groupId': 'OG001', 'lowerLimit': '2.89', 'upperLimit': '3.73'}, {'value': '4.01', 'groupId': 'OG002', 'lowerLimit': '3.53', 'upperLimit': '4.56'}]}]}, {'title': 'Anti-5, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.27', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '3.7'}, {'value': '3.27', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '3.68'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Anti-6B, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.71'}, {'value': '1.41', 'groupId': 'OG001', 'lowerLimit': '1.19', 'upperLimit': '1.67'}, {'value': '2.52', 'groupId': 'OG002', 'lowerLimit': '2.15', 'upperLimit': '2.96'}]}]}, {'title': 'Anti-7F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.79', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '4.23'}, {'value': '4.06', 'groupId': 'OG001', 'lowerLimit': '3.63', 'upperLimit': '4.54'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Anti-9V, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.96', 'groupId': 'OG000', 'lowerLimit': '3.58', 'upperLimit': '4.39'}, {'value': '4.23', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': '4.74'}, {'value': '6.05', 'groupId': 'OG002', 'lowerLimit': '5.38', 'upperLimit': '6.8'}]}]}, {'title': 'Anti-14, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.59', 'groupId': 'OG000', 'lowerLimit': '4.06', 'upperLimit': '5.19'}, {'value': '4.95', 'groupId': 'OG001', 'lowerLimit': '4.38', 'upperLimit': '5.6'}, {'value': '7.31', 'groupId': 'OG002', 'lowerLimit': '6.37', 'upperLimit': '8.39'}]}]}, {'title': 'Anti-18C, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.36', 'groupId': 'OG000', 'lowerLimit': '5.56', 'upperLimit': '7.27'}, {'value': '4.63', 'groupId': 'OG001', 'lowerLimit': '4.09', 'upperLimit': '5.25'}, {'value': '5.08', 'groupId': 'OG002', 'lowerLimit': '4.47', 'upperLimit': '5.78'}]}]}, {'title': 'Anti-19F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.45', 'groupId': 'OG000', 'lowerLimit': '4.72', 'upperLimit': '6.3'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.04', 'upperLimit': '6.68'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '2.14', 'upperLimit': '2.7'}]}]}, {'title': 'Anti-23F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.32', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '2.71'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2.24', 'upperLimit': '3.02'}, {'value': '5.32', 'groupId': 'OG002', 'lowerLimit': '4.49', 'upperLimit': '6.31'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior (Month 9) to and one month after the administration of the booster dose (Month 10)', 'description': 'Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Opsono-1, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '6.4'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '6.7'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '5.8'}]}]}, {'title': 'Opsono-4, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '14.9'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '20.6'}, {'value': '12.3', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '16.2'}]}]}, {'title': 'Opsono-5, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '8.5'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '8.1'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '4.6'}]}]}, {'title': 'Opsono-6B, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '77.7'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '63.1', 'upperLimit': '148'}, {'value': '27.4', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '40.3'}]}]}, {'title': 'Opsono-7F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '818.9', 'groupId': 'OG000', 'lowerLimit': '642.2', 'upperLimit': '1044.3'}, {'value': '754.3', 'groupId': 'OG001', 'lowerLimit': '598.4', 'upperLimit': '950.8'}, {'value': '138.1', 'groupId': 'OG002', 'lowerLimit': '91.2', 'upperLimit': '209.2'}]}]}, {'title': 'Opsono-9V, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '267.2', 'groupId': 'OG000', 'lowerLimit': '212.7', 'upperLimit': '335.8'}, {'value': '338.7', 'groupId': 'OG001', 'lowerLimit': '264.8', 'upperLimit': '433.2'}, {'value': '149.5', 'groupId': 'OG002', 'lowerLimit': '112.4', 'upperLimit': '198.9'}]}]}, {'title': 'Opsono-14, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '117.3', 'groupId': 'OG000', 'lowerLimit': '82.9', 'upperLimit': '165.9'}, {'value': '142.5', 'groupId': 'OG001', 'lowerLimit': '101.3', 'upperLimit': '200.4'}, {'value': '156', 'groupId': 'OG002', 'lowerLimit': '114.5', 'upperLimit': '212.5'}]}]}, {'title': 'Opsono-18C, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '10.8'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '8.5'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '8.7'}]}]}, {'title': 'Opsono-19F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '18.1'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '20.2'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '9.9'}]}]}, {'title': 'Opsono-23F, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '314.1', 'groupId': 'OG000', 'lowerLimit': '198.6', 'upperLimit': '496.7'}, {'value': '350.4', 'groupId': 'OG001', 'lowerLimit': '229.8', 'upperLimit': '534.2'}, {'value': '338.9', 'groupId': 'OG002', 'lowerLimit': '219.9', 'upperLimit': '522.3'}]}]}, {'title': 'Opsono-1, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '208.8', 'groupId': 'OG000', 'lowerLimit': '106.6', 'upperLimit': '271.7'}, {'value': '221.4', 'groupId': 'OG001', 'lowerLimit': '165.1', 'upperLimit': '297'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '5.1'}]}]}, {'title': 'Opsono-4, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1046.8', 'groupId': 'OG000', 'lowerLimit': '865.8', 'upperLimit': '1265.7'}, {'value': '1121.6', 'groupId': 'OG001', 'lowerLimit': '909.4', 'upperLimit': '1383.3'}, {'value': '2335.8', 'groupId': 'OG002', 'lowerLimit': '1946.3', 'upperLimit': '2803.3'}]}]}, {'title': 'Opsono-5, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '149.3', 'groupId': 'OG000', 'lowerLimit': '119.2', 'upperLimit': '187'}, {'value': '132.4', 'groupId': 'OG001', 'lowerLimit': '103.8', 'upperLimit': '168.9'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '4.3'}]}]}, {'title': 'Opsono-6B, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '681.4', 'groupId': 'OG000', 'lowerLimit': '514.6', 'upperLimit': '902.1'}, {'value': '763.3', 'groupId': 'OG001', 'lowerLimit': '581.9', 'upperLimit': '1001.3'}, {'value': '1807.5', 'groupId': 'OG002', 'lowerLimit': '1408', 'upperLimit': '2320.3'}]}]}, {'title': 'Opsono-7F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3936.5', 'groupId': 'OG000', 'lowerLimit': '3413.2', 'upperLimit': '4540'}, {'value': '3976', 'groupId': 'OG001', 'lowerLimit': '3390.2', 'upperLimit': '4663.1'}, {'value': '129.1', 'groupId': 'OG002', 'lowerLimit': '85.9', 'upperLimit': '193.9'}]}]}, {'title': 'Opsono-9V, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2512.9', 'groupId': 'OG000', 'lowerLimit': '2213.1', 'upperLimit': '2853.2'}, {'value': '2257.6', 'groupId': 'OG001', 'lowerLimit': '1974.3', 'upperLimit': '2581.5'}, {'value': '3889.5', 'groupId': 'OG002', 'lowerLimit': '3260.1', 'upperLimit': '4640.2'}]}]}, {'title': 'Opsono-14, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1534.2', 'groupId': 'OG000', 'lowerLimit': '1290.9', 'upperLimit': '1823.3'}, {'value': '1896.3', 'groupId': 'OG001', 'lowerLimit': '1591.3', 'upperLimit': '2259.7'}, {'value': '1867.9', 'groupId': 'OG002', 'lowerLimit': '1540.5', 'upperLimit': '2265.1'}]}]}, {'title': 'Opsono-18C, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '720.7', 'groupId': 'OG000', 'lowerLimit': '597.5', 'upperLimit': '869.4'}, {'value': '385.9', 'groupId': 'OG001', 'lowerLimit': '303.5', 'upperLimit': '490.8'}, {'value': '660.4', 'groupId': 'OG002', 'lowerLimit': '520.9', 'upperLimit': '837.3'}]}]}, {'title': 'Opsono-19F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '435.7', 'groupId': 'OG000', 'lowerLimit': '336.3', 'upperLimit': '564.5'}, {'value': '475.4', 'groupId': 'OG001', 'lowerLimit': '377.8', 'upperLimit': '598.1'}, {'value': '123.2', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '158.2'}]}]}, {'title': 'Opsono-23F, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2895.4', 'groupId': 'OG000', 'lowerLimit': '2276.1', 'upperLimit': '3683.1'}, {'value': '2895.3', 'groupId': 'OG001', 'lowerLimit': '2419.3', 'upperLimit': '3465'}, {'value': '12418.7', 'groupId': 'OG002', 'lowerLimit': '10171.8', 'upperLimit': '15161.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior (Month 9) to and one month after the administration of the booster dose(Month 10)', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-6A, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19A, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6A, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19A, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior (Month 9) to and one month after the administration of the booster dose(Month 10)', 'description': 'Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-6A, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.12'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.13'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.07'}]}]}, {'title': 'Anti-19A, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.15'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.13'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.07'}]}]}, {'title': 'Anti-6A, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.36', 'upperLimit': '0.55'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.61'}, {'value': '0.71', 'groupId': 'OG002', 'lowerLimit': '0.58', 'upperLimit': '0.88'}]}]}, {'title': 'Anti-19A, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.63'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.66'}, {'value': '0.21', 'groupId': 'OG002', 'lowerLimit': '0.17', 'upperLimit': '0.25'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior (Month 9) to and one month after the administration of the booster dose (Month 10)', 'description': 'Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Opsono-6A, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '34.6'}, {'value': '30.7', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '45.2'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '21.6'}]}]}, {'title': 'Opsono-19A, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '7'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '6.5'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '6.5'}]}]}, {'title': 'Opsono-6A, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '143.3', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '207.3'}, {'value': '197.1', 'groupId': 'OG001', 'lowerLimit': '138', 'upperLimit': '281.3'}, {'value': '493.3', 'groupId': 'OG002', 'lowerLimit': '357.1', 'upperLimit': '681.6'}]}]}, {'title': 'Opsono-19A, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '49.2'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '34.3'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '9.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Month 9) and one month after the administration of the booster dose (Month 10)', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-PD, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '421', 'groupId': 'OG000', 'lowerLimit': '370.3', 'upperLimit': '478.5'}, {'value': '520.5', 'groupId': 'OG001', 'lowerLimit': '455.8', 'upperLimit': '594.3'}, {'value': '80.8', 'groupId': 'OG002', 'lowerLimit': '73.1', 'upperLimit': '89.4'}]}]}, {'title': 'Anti-PD, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1715', 'groupId': 'OG000', 'lowerLimit': '1510.3', 'upperLimit': '1947.5'}, {'value': '1936.8', 'groupId': 'OG001', 'lowerLimit': '1710.5', 'upperLimit': '2193.2'}, {'value': '84.1', 'groupId': 'OG002', 'lowerLimit': '76', 'upperLimit': '93.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior (Month 9) to and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-diphteria, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.235', 'groupId': 'OG000', 'lowerLimit': '0.205', 'upperLimit': '0.27'}, {'value': '0.232', 'groupId': 'OG001', 'lowerLimit': '0.203', 'upperLimit': '0.264'}, {'value': '0.266', 'groupId': 'OG002', 'lowerLimit': '0.235', 'upperLimit': '0.301'}]}]}, {'title': 'Anti-tetanus, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.728', 'groupId': 'OG000', 'lowerLimit': '0.656', 'upperLimit': '0.809'}, {'value': '0.536', 'groupId': 'OG001', 'lowerLimit': '0.477', 'upperLimit': '0.603'}, {'value': '0.232', 'groupId': 'OG002', 'lowerLimit': '0.202', 'upperLimit': '0.267'}]}]}, {'title': 'Anti-diphteria, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.061', 'groupId': 'OG000', 'lowerLimit': '3.601', 'upperLimit': '4.58'}, {'value': '3.226', 'groupId': 'OG001', 'lowerLimit': '2.866', 'upperLimit': '3.632'}, {'value': '4.882', 'groupId': 'OG002', 'lowerLimit': '4.425', 'upperLimit': '5.386'}]}]}, {'title': 'Anti-tetanus, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.628', 'groupId': 'OG000', 'lowerLimit': '7.867', 'upperLimit': '9.462'}, {'value': '5.989', 'groupId': 'OG001', 'lowerLimit': '5.461', 'upperLimit': '6.568'}, {'value': '3.248', 'groupId': 'OG002', 'lowerLimit': '2.859', 'upperLimit': '3.69'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Month 9) and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-PRP, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.475', 'groupId': 'OG000', 'lowerLimit': '0.386', 'upperLimit': '0.585'}, {'value': '0.855', 'groupId': 'OG001', 'lowerLimit': '0.682', 'upperLimit': '1.072'}, {'value': '0.371', 'groupId': 'OG002', 'lowerLimit': '0.298', 'upperLimit': '0.461'}]}]}, {'title': 'Anti-PRP, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.331', 'groupId': 'OG000', 'lowerLimit': '16.144', 'upperLimit': '23.147'}, {'value': '39.383', 'groupId': 'OG001', 'lowerLimit': '32.617', 'upperLimit': '47.551'}, {'value': '23.676', 'groupId': 'OG002', 'lowerLimit': '18.944', 'upperLimit': '29.591'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to (Month 9) and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-PT, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '8.4'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '6.7'}, {'value': '6.6', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '7.3'}]}]}, {'title': 'Anti-FHA, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '29.4', 'upperLimit': '39.4'}, {'value': '35.3', 'groupId': 'OG001', 'lowerLimit': '30.8', 'upperLimit': '40.6'}, {'value': '34.7', 'groupId': 'OG002', 'lowerLimit': '30.1', 'upperLimit': '39.9'}]}]}, {'title': 'Anti-PRN, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '16.2'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '7.9'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '10'}]}]}, {'title': 'Anti-PT, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '59.2'}, {'value': '47.4', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '52.5'}, {'value': '54.8', 'groupId': 'OG002', 'lowerLimit': '48.9', 'upperLimit': '61.4'}]}]}, {'title': 'Anti-FHA, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '343.5', 'groupId': 'OG000', 'lowerLimit': '308', 'upperLimit': '383.1'}, {'value': '135.7', 'groupId': 'OG001', 'lowerLimit': '121.2', 'upperLimit': '151.9'}, {'value': '140', 'groupId': 'OG002', 'lowerLimit': '123.2', 'upperLimit': '159.1'}]}]}, {'title': 'Anti-PRN, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '281.7', 'groupId': 'OG000', 'lowerLimit': '247.2', 'upperLimit': '321'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '85.4', 'upperLimit': '112'}, {'value': '106.4', 'groupId': 'OG002', 'lowerLimit': '91.5', 'upperLimit': '123.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior (Month 9) to and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-HBs, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '142.1', 'groupId': 'OG000', 'lowerLimit': '113.4', 'upperLimit': '178.1'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '11.2'}, {'value': '9.9', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '11.2'}]}]}, {'title': 'Anti-HBs, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1981', 'groupId': 'OG000', 'lowerLimit': '1552', 'upperLimit': '2528.7'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '9.9'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '9.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior (Month 9) to and one month after (Month 10) the administration of the booster dose', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \\> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \\> 100 mIU/mL or CLIA concentration \\> 10 mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-polio 1, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '8.4'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '8'}]}]}, {'title': 'Anti-polio 2, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '16.6'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '12.7'}, {'value': '10.4', 'groupId': 'OG002', 'lowerLimit': '8.9', 'upperLimit': '12.2'}]}]}, {'title': 'Anti-polio 3, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '13.9'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '10.7'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '10.3'}]}]}, {'title': 'Anti-polio 1, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '370.7', 'groupId': 'OG000', 'lowerLimit': '289.8', 'upperLimit': '474.2'}, {'value': '177.5', 'groupId': 'OG001', 'lowerLimit': '135.8', 'upperLimit': '231.9'}, {'value': '221.2', 'groupId': 'OG002', 'lowerLimit': '171.5', 'upperLimit': '285.3'}]}]}, {'title': 'Anti-polio 2, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '710.8', 'groupId': 'OG000', 'lowerLimit': '588', 'upperLimit': '859'}, {'value': '338.8', 'groupId': 'OG001', 'lowerLimit': '272.7', 'upperLimit': '420.8'}, {'value': '481.4', 'groupId': 'OG002', 'lowerLimit': '391', 'upperLimit': '592.7'}]}]}, {'title': 'Anti-polio 3, Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '631.5', 'groupId': 'OG000', 'lowerLimit': '495.7', 'upperLimit': '804.4'}, {'value': '311.9', 'groupId': 'OG001', 'lowerLimit': '240.4', 'upperLimit': '404.6'}, {'value': '348.3', 'groupId': 'OG002', 'lowerLimit': '263.6', 'upperLimit': '460.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior (Month 9) to and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-PT, S- seronegative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PT, S+ seropositive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA, S- seronegative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Anti-FHA, S+ seropositive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN, S- seronegative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PRN, S+ seropositive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after (Month 10) the administration of the booster dose', 'description': 'A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations \\< 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-1, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Anti-4, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}]}, {'title': 'Anti-5, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Anti-6B, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}]}, {'title': 'Anti-7F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Anti-9V, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}]}, {'title': 'Anti-14, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}]}, {'title': 'Anti-18C, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}]}, {'title': 'Anti-23F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-1, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.35'}, {'value': '0.32', 'groupId': 'OG001', 'lowerLimit': '0.28', 'upperLimit': '0.38'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Anti-4, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.29'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '0.34'}, {'value': '0.36', 'groupId': 'OG002', 'lowerLimit': '0.32', 'upperLimit': '0.42'}]}]}, {'title': 'Anti-5, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.53'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.55'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.05'}]}]}, {'title': 'Anti-6B, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.36'}, {'value': '0.32', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.4'}, {'value': '0.46', 'groupId': 'OG002', 'lowerLimit': '0.38', 'upperLimit': '0.56'}]}]}, {'title': 'Anti-7F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.81'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '0.84'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.05'}]}]}, {'title': 'Anti-9V, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.88'}, {'value': '0.78', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '0.91'}, {'value': '0.81', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '0.94'}]}]}, {'title': 'Anti-14, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '0.86'}, {'value': '0.85', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '0.99'}, {'value': '1.28', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '1.48'}]}]}, {'title': 'Anti-18C, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.19'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.56', 'upperLimit': '0.74'}, {'value': '1.66', 'groupId': 'OG002', 'lowerLimit': '1.59', 'upperLimit': '1.75'}]}]}, {'title': 'Anti-19F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.48', 'groupId': 'OG000', 'lowerLimit': '1.22', 'upperLimit': '1.8'}, {'value': '1.46', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.78'}, {'value': '1.76', 'groupId': 'OG002', 'lowerLimit': '1.59', 'upperLimit': '1.98'}]}]}, {'title': 'Anti-23F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.63'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '1.63'}, {'value': '1.01', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '1.24'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Opsono-1, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '14.1'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '12.5'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '4.7'}]}]}, {'title': 'Opsono-4, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '15.9'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '21.7'}, {'value': '45.2', 'groupId': 'OG002', 'lowerLimit': '30.8', 'upperLimit': '66.5'}]}]}, {'title': 'Opsono-5, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '16'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '17.1'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '4.3'}]}]}, {'title': 'Opsono-6B, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000', 'lowerLimit': '48.8', 'upperLimit': '123.8'}, {'value': '137.6', 'groupId': 'OG001', 'lowerLimit': '83.5', 'upperLimit': '226.6'}, {'value': '220', 'groupId': 'OG002', 'lowerLimit': '145.4', 'upperLimit': '332.8'}]}]}, {'title': 'Opsono-7F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1982.9', 'groupId': 'OG000', 'lowerLimit': '1568.8', 'upperLimit': '2506.2'}, {'value': '2205.6', 'groupId': 'OG001', 'lowerLimit': '1833.4', 'upperLimit': '2653.4'}, {'value': '738.1', 'groupId': 'OG002', 'lowerLimit': '549.8', 'upperLimit': '990.7'}]}]}, {'title': 'Opsono-9V, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '465.9', 'groupId': 'OG000', 'lowerLimit': '324.2', 'upperLimit': '669.5'}, {'value': '470', 'groupId': 'OG001', 'lowerLimit': '325.8', 'upperLimit': '677.9'}, {'value': '476.2', 'groupId': 'OG002', 'lowerLimit': '317.8', 'upperLimit': '713.5'}]}]}, {'title': 'Opsono-14, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '144.4'}, {'value': '151.6', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '235.4'}, {'value': '238.7', 'groupId': 'OG002', 'lowerLimit': '163.5', 'upperLimit': '348.6'}]}]}, {'title': 'Opsono-18C, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '30.6'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '17.6'}, {'value': '15.3', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': '21.3'}]}]}, {'title': 'Opsono-19F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '42.8'}, {'value': '32.9', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '45.4'}, {'value': '15.1', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '20.6'}]}]}, {'title': 'Opsono-23F, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '366.5', 'groupId': 'OG000', 'lowerLimit': '218.3', 'upperLimit': '615.3'}, {'value': '706.1', 'groupId': 'OG001', 'lowerLimit': '443.5', 'upperLimit': '1124.3'}, {'value': '3879.8', 'groupId': 'OG002', 'lowerLimit': '2774.4', 'upperLimit': '5425.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-6A, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}]}, {'title': 'Anti-19A, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Anti-6A, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.17'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.19'}, {'value': '0.22', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '0.27'}]}]}, {'title': 'Anti-19A, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.53'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.36'}, {'value': '0.21', 'groupId': 'OG002', 'lowerLimit': '0.16', 'upperLimit': '0.27'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Opsono-6A, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '33.1'}, {'value': '24.8', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '39.5'}, {'value': '56.5', 'groupId': 'OG002', 'lowerLimit': '36.4', 'upperLimit': '87.7'}]}]}, {'title': 'Opsono-19A, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '16.7'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '11.9'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '12.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000', 'lowerLimit': '287.1', 'upperLimit': '384'}, {'value': '423', 'groupId': 'OG001', 'lowerLimit': '359.9', 'upperLimit': '497.1'}, {'value': '81.4', 'groupId': 'OG002', 'lowerLimit': '73.1', 'upperLimit': '90.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Any SP, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Any SP, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Any SP, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'Any SP, Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}]}, {'title': 'Any SP, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)', 'description': 'Positive cultures of H. influenzae\\* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \\*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'S. pneumoniae, VS - M3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, VS - M9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, VS - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, VS - M16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, VS - M21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)', 'description': 'Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Any SP, M9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}, {'title': 'Any SP, M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}]}, {'title': 'Any SP, M16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'Any SP, M21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, M9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, M16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Any HI, M21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)', 'description': 'Acquisition of new H. influenzae\\* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \\*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'S. pneumoniae, VS - M9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, VS - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, VS - M16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, VS - M21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, CRS - M21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'S. pneumoniae, OS - M21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)', 'description': 'Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Local Symptoms - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each dose and across doses', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond (\\>) 30 millimeters from injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms - Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Any Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'Any Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Any Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Any Drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following 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. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 31-day (Days 0-30) post-primary 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 Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the entire study period (up to Month 21)', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Local Symptoms -Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following booster dose', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling \\> 30 millimeters from injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following booster dose', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'OG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'OG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 31-day (Days 0-30) after booster 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" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'FG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'FG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}], 'periods': [{'title': 'Primary Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '260'}, {'groupId': 'FG002', 'numSubjects': '260'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '260'}, {'groupId': 'FG002', 'numSubjects': '260'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Booster Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '259'}, {'groupId': 'FG002', 'numSubjects': '258'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '258'}, {'groupId': 'FG002', 'numSubjects': '258'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse event, non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study included a Primary (PRI) Phase, up to Month 3, followed by a Booster (BST) Phase, up to Month 9.', 'preAssignmentDetails': "At screening the following was performed: informed consent was obtained and signed from subjects' parents/guardians, check for inclusion/exclusion criteria and contraindications/precautions was performed as regards to vaccination, and medical history of subjects was collected. Subjects' pre-vaccination body temperature was evaluated."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '780', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Synflorix + Infanrix Hexa Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.'}, {'id': 'BG001', 'title': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.'}, {'id': 'BG002', 'title': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '1.29', 'groupId': 'BG001'}, {'value': '7.6', 'spread': '1.26', 'groupId': 'BG002'}, {'value': '7.53', 'spread': '1.25', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '396', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic ancestry', 'categories': [{'title': 'African heritage/African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian - Central/South Asian heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White - Arabic/North African heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White - Caucasian/European heritage', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}, {'value': '769', 'groupId': 'BG003'}]}, {'title': 'Unspecified', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 780}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'dispFirstSubmitDate': '2011-11-17', 'completionDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-11', 'studyFirstSubmitDate': '2008-03-21', 'dispFirstSubmitQcDate': '2011-11-17', 'resultsFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2008-04-01', 'dispFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-13', 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination', 'timeFrame': 'At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine', 'description': 'Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.'}, {'measure': 'Antibody Concentration Against Protein D (PD) - Primary Vaccination', 'timeFrame': 'At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine', 'description': 'Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.'}, {'measure': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.'}, {'measure': 'Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.'}, {'measure': 'Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.'}, {'measure': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.'}, {'measure': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \\> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \\> 100 mIU/mL or CLIA concentration \\> 10 mIU/mL.'}, {'measure': 'Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.', 'timeFrame': 'At Month 3, one month after the administration of the third vaccine dose', 'description': 'Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.'}, {'measure': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination', 'timeFrame': 'Prior to (Month 9) and one month after the administration of the booster dose (Month 10)', 'description': 'Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination', 'timeFrame': 'Prior (Month 9) to and one month after the administration of the booster dose (Month 10)', 'description': 'Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination', 'timeFrame': 'Prior (Month 9) to and one month after the administration of the booster dose(Month 10)', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.'}, {'measure': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.', 'timeFrame': 'Prior (Month 9) to and one month after the administration of the booster dose(Month 10)', 'description': 'Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination', 'timeFrame': 'Prior (Month 9) to and one month after the administration of the booster dose (Month 10)', 'description': 'Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.', 'timeFrame': 'Prior to (Month 9) and one month after the administration of the booster dose (Month 10)', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.'}, {'measure': 'Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.', 'timeFrame': 'Prior (Month 9) to and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.'}, {'measure': 'Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.', 'timeFrame': 'Prior to (Month 9) and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.'}, {'measure': 'Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination', 'timeFrame': 'Prior to (Month 9) and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.'}, {'measure': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.', 'timeFrame': 'Prior (Month 9) to and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.'}, {'measure': 'Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.', 'timeFrame': 'Prior (Month 9) to and one month after (Month 10) the administration of the booster dose', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \\> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \\> 100 mIU/mL or CLIA concentration \\> 10 mIU/mL.'}, {'measure': 'Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.', 'timeFrame': 'Prior (Month 9) to and one month after (Month 10) the administration of the booster dose', 'description': 'Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.'}, {'measure': 'Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.', 'timeFrame': 'One month after (Month 10) the administration of the booster dose', 'description': 'A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations \\< 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL).'}, {'measure': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.'}, {'measure': 'Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.'}, {'measure': 'Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.'}, {'measure': 'Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.', 'timeFrame': 'At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)', 'description': 'Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.'}, {'measure': 'Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.', 'timeFrame': 'One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)', 'description': 'Positive cultures of H. influenzae\\* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \\*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.'}, {'measure': 'Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.', 'timeFrame': 'One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)', 'description': 'Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).'}, {'measure': 'Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.', 'timeFrame': 'Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)', 'description': 'Acquisition of new H. influenzae\\* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \\*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.'}, {'measure': 'Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.', 'timeFrame': 'Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)', 'description': 'Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).'}, {'measure': 'Number of Subjects With Solicited Local Symptoms - Primary Vaccination', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each dose and across doses', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond (\\>) 30 millimeters from injection site.'}, {'measure': 'Number of Subjects With Solicited General Symptoms - Primary Vaccination', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following 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. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.', 'timeFrame': 'Within the 31-day (Days 0-30) post-primary 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': 'Throughout the entire study period (up to Month 21)', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.'}, {'measure': 'Number of Subjects With Solicited Local Symptoms -Booster Vaccination', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following booster dose', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling \\> 30 millimeters from injection site.'}, {'measure': 'Number of Subjects With Solicited General Symptoms - Booster Vaccination.', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following booster dose', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.', 'timeFrame': 'Within the 31-day (Days 0-30) after booster 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" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.'}]}, 'conditionsModule': {'conditions': ['Infections, Streptococcal']}, 'referencesModule': {'availIpds': [{'id': '110142', '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. The results of this study 110142 are summarised with study 111053 on GSK Clinical Study Register'}, {'id': '110142', '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': '110142', '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': '110142', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110142', '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': '110142', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110142', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '21487327', 'type': 'BACKGROUND', 'citation': 'van den Bergh MR, Spijkerman J, Francois N, Swinnen K, Borys D, Schuerman L, Veenhoven RH, Sanders EA. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine and DTPa-IPV-Hib when coadministered as a 3-dose primary vaccination schedule in The Netherlands: a randomized controlled trial. Pediatr Infect Dis J. 2011 Sep;30(9):e170-8. doi: 10.1097/INF.0b013e31821a0614.'}, {'pmid': '23118268', 'type': 'BACKGROUND', 'citation': 'van den Bergh MR, Spijkerman J, Swinnen KM, Francois NA, Pascal TG, Borys D, Schuerman L, Ijzerman EP, Bruin JP, van der Ende A, Veenhoven RH, Sanders EA. Effects of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine on nasopharyngeal bacterial colonization in young children: a randomized controlled trial. Clin Infect Dis. 2013 Feb;56(3):e30-9. doi: 10.1093/cid/cis922. Epub 2012 Nov 1.'}, {'pmid': '27097348', 'type': 'BACKGROUND', 'citation': 'van den Bergh MR, Spijkerman J, Francois N, Swinnen K, Borys D, Schuerman L, Veenhoven RH, Sanders EA. Immunogenicity, Safety and Reactogenicity of a Booster Dose of the 10-Valent Pneumococcal Nontypeable H. influenzae Protein D Conjugate Vaccine Coadministered With DTPa-IPV-Hib in Dutch Children: A Randomized Controlled Trial. Pediatr Infect Dis J. 2016 Jul;35(7):e206-19. doi: 10.1097/INF.0000000000001170.'}], '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': 'The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. 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* Subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.\n* A male or female between, and including, 6-12 weeks (42-90 days) of age at the time of the first vaccination.\n* Written informed consent obtained from both parents or from the guardian(s) 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 of at least 36 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* Concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.\n* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from one month (30 days) before and up to one month (30 days) after each dose of study vaccine.\n* Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae.\n* Children for whom hepatitis B vaccination is required according to the local recommendations\n* History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* History of any neurologic disorders or seizures.\n* Acute disease at the time of enrolment.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination\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 study period.'}, 'identificationModule': {'nctId': 'NCT00652951', 'briefTitle': 'Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Non-inferiority of Co-administration of GSK Biologicals'Pneumococcal Conjugate Vaccine GSK1024850A With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib.", 'orgStudyIdInfo': {'id': '110142'}, 'secondaryIdInfos': [{'id': '111053'}, {'id': '2007-004002-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Synflorix + Infanrix hexa Group', 'description': 'Subjects received 3 doses of SynflorixTM vaccine co-administered with Infanrix hexaTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (Infanrix hexaTM) thigh or deltoid.', 'interventionNames': ['Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)', 'Biological: Infanrix™ hexa.']}, {'type': 'EXPERIMENTAL', 'label': 'Synflorix + Pediacel Group', 'description': 'Subjects received 3 doses of SynflorixTM vaccine co-administered with PediacelTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (PediacelTM) thigh or deltoid.thigh or deltoid.', 'interventionNames': ['Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)', 'Biological: Pediacel™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevenar + Pediacel Group', 'description': 'Subjects received 3 doses of PrevenarTM co-administered with PediacelTM vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (PrevenarTM) or left (PediacelTM) thigh or deltoid.', 'interventionNames': ['Biological: Pediacel™', 'Biological: Prevenar™']}], 'interventions': [{'name': 'GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination', 'armGroupLabels': ['Synflorix + Infanrix hexa Group', 'Synflorix + Pediacel Group']}, {'name': 'Infanrix™ hexa.', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination', 'armGroupLabels': ['Synflorix + Infanrix hexa Group']}, {'name': 'Pediacel™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination', 'armGroupLabels': ['Prevenar + Pediacel Group', 'Synflorix + Pediacel Group']}, {'name': 'Prevenar™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination', 'armGroupLabels': ['Prevenar + Pediacel Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2134 TM', 'city': 'Hoofddorp', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}