Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 5:28 PM
Study NCT ID:
NCT01616459
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2012-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D006192', 'term': 'Haemophilus 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'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547294', 'term': 'PHiD-CV vaccine'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}]}}, '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 symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11).', 'description': 'Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.', 'eventGroups': [{'id': 'EG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).', 'otherNumAtRisk': 240, 'deathsNumAtRisk': 240, 'otherNumAffected': 234, 'seriousNumAtRisk': 240, 'deathsNumAffected': 0, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).', 'otherNumAtRisk': 240, 'deathsNumAtRisk': 240, 'otherNumAffected': 229, 'seriousNumAtRisk': 240, 'deathsNumAffected': 0, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 221, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 38}, {'id': 'EG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).', 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 235, 'seriousNumAtRisk': 241, 'deathsNumAffected': 0, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Pain', 'notes': 'Symptom reported during the 4-day post-primary vaccination periods , across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 141}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 134}, {'groupId': 'EG003', 'numAtRisk': 238, 'numAffected': 126}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Redness', 'notes': 'Symptom reported during the 4-day post-primary vaccination periods , across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 130}, {'groupId': 'EG003', 'numAtRisk': 238, 'numAffected': 134}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Swelling', 'notes': 'Symptom reported during the 4-day post-primary vaccination periods , across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 91}, {'groupId': 'EG003', 'numAtRisk': 238, 'numAffected': 93}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drowsiness', 'notes': 'Symptom reported during the 4-day post-primary vaccination periods , across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 178}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 162}, {'groupId': 'EG003', 'numAtRisk': 238, 'numAffected': 168}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability/Fussiness', 'notes': 'Symptom reported during the 4-day post-primary vaccination periods , across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 202}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 203}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 185}, {'groupId': 'EG003', 'numAtRisk': 238, 'numAffected': 186}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of appetite', 'notes': 'Symptom reported during the 4-day post-primary vaccination periods , across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 132}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 125}, {'groupId': 'EG003', 'numAtRisk': 238, 'numAffected': 125}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fever (rectal temperature ≥ 38°C)', 'notes': 'Symptom reported during the 4-day post-primary vaccination periods , across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 228, 'numAffected': 148}, {'groupId': 'EG003', 'numAtRisk': 238, 'numAffected': 143}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchiolitis', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'notes': 'Symptom reported during the 4-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 123}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 119}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 110}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Redness', 'notes': 'Symptom reported during the 4-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 108}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Swelling', 'notes': 'Symptom reported during the 4-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 89}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 85}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drowsiness', 'notes': 'Symptom reported during the 4-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 84}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 96}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability/Fusiness', 'notes': 'Symptom reported during the 4-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 136}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 137}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 129}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of appetite', 'notes': 'Symptom reported during the 4-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 83}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fever (rectal temperature ≥ 38°C)', 'notes': 'Symptom reported during the 4-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 231, 'numAffected': 75}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'notes': 'Unsolicited AE reported during the 31-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 234, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Conjunctivitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Milk allergy', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacteraemia', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacterial pyelonephritis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast abscess', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchiolitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis viral', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchopneumonia', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Escherichia urinary tract infection', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pertussis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia respiratory syncytial viral', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tracheitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection bacterial', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concussion', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toxicity to various agents', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotonic-hyporesponsive episode', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myoclonus', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis chronic', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile convulsion', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis rotavirus', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head injury', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchospasm', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Impetigo', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory syncytial virus bronchitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenoiditis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atelectasis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchiectasis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Burning sensation', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dacryostenosis congenital', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis allergic', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Escherichia pyelonephritis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Exposure to toxic agent', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foreign body', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis adenovirus', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotonia', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ingrowing nail', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral discitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media acute', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paronychia', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngotonsillitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyomyositis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection viral', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinoblastoma', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thermal burn', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicella', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral tonsillitis', 'notes': 'SAE reported between Day 0 and Month 11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 241, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '219', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).'}], 'classes': [{'title': 'ANTI-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.54', 'groupId': 'OG000', 'lowerLimit': '1.37', 'upperLimit': '1.74'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '1.79'}, {'value': '1.37', 'groupId': 'OG002', 'lowerLimit': '1.21', 'upperLimit': '1.54'}, {'value': '2.18', 'groupId': 'OG003', 'lowerLimit': '1.97', 'upperLimit': '2.42'}]}]}, {'title': 'ANTI-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.06'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.07'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.06'}, {'value': '2.27', 'groupId': 'OG003', 'lowerLimit': '2.06', 'upperLimit': '2.49'}]}]}, {'title': 'ANTI-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.78', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '2.02'}, {'value': '1.99', 'groupId': 'OG001', 'lowerLimit': '1.73', 'upperLimit': '2.28'}, {'value': '1.68', 'groupId': 'OG002', 'lowerLimit': '1.47', 'upperLimit': '1.93'}, {'value': '2.83', 'groupId': 'OG003', 'lowerLimit': '2.60', 'upperLimit': '3.09'}]}]}, {'title': 'ANTI-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '2.74'}, {'value': '2.37', 'groupId': 'OG001', 'lowerLimit': '2.13', 'upperLimit': '2.64'}, {'value': '2.19', 'groupId': 'OG002', 'lowerLimit': '1.97', 'upperLimit': '2.44'}, {'value': '2.81', 'groupId': 'OG003', 'lowerLimit': '2.52', 'upperLimit': '3.13'}]}]}, {'title': 'ANTI-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.17'}, {'value': '1.12', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '1.34'}, {'value': '0.12', 'groupId': 'OG002', 'lowerLimit': '0.10', 'upperLimit': '0.14'}, {'value': '2.05', 'groupId': 'OG003', 'lowerLimit': '1.81', 'upperLimit': '2.32'}]}]}, {'title': 'ANTI-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.61'}, {'value': '0.58', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '0.69'}, {'value': '0.48', 'groupId': 'OG002', 'lowerLimit': '0.40', 'upperLimit': '0.58'}, {'value': '0.49', 'groupId': 'OG003', 'lowerLimit': '0.42', 'upperLimit': '0.58'}]}]}, {'title': 'ANTI-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '219', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': '2.52'}, {'value': '2.44', 'groupId': 'OG001', 'lowerLimit': '2.18', 'upperLimit': '2.72'}, {'value': '2.20', 'groupId': 'OG002', 'lowerLimit': '1.97', 'upperLimit': '2.47'}, {'value': '3.16', 'groupId': 'OG003', 'lowerLimit': '2.91', 'upperLimit': '3.43'}]}]}, {'title': 'ANTI-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.57', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '1.76'}, {'value': '1.77', 'groupId': 'OG001', 'lowerLimit': '1.58', 'upperLimit': '1.97'}, {'value': '1.42', 'groupId': 'OG002', 'lowerLimit': '1.27', 'upperLimit': '1.59'}, {'value': '2.27', 'groupId': 'OG003', 'lowerLimit': '2.05', 'upperLimit': '2.51'}]}]}, {'title': 'ANTI-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.19', 'groupId': 'OG000', 'lowerLimit': '3.72', 'upperLimit': '4.71'}, {'value': '4.45', 'groupId': 'OG001', 'lowerLimit': '3.95', 'upperLimit': '5.00'}, {'value': '4.21', 'groupId': 'OG002', 'lowerLimit': '3.72', 'upperLimit': '4.77'}, {'value': '4.20', 'groupId': 'OG003', 'lowerLimit': '3.68', 'upperLimit': '4.80'}]}]}, {'title': 'ANTI-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '219', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.84', 'groupId': 'OG000', 'lowerLimit': '2.45', 'upperLimit': '3.28'}, {'value': '2.56', 'groupId': 'OG001', 'lowerLimit': '2.21', 'upperLimit': '2.96'}, {'value': '2.56', 'groupId': 'OG002', 'lowerLimit': '2.19', 'upperLimit': '2.98'}, {'value': '3.17', 'groupId': 'OG003', 'lowerLimit': '2.87', 'upperLimit': '3.51'}]}]}, {'title': 'ANTI-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '219', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '1.86'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.36'}, {'value': '0.18', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.22'}, {'value': '2.67', 'groupId': 'OG003', 'lowerLimit': '2.39', 'upperLimit': '3.00'}]}]}, {'title': 'ANTI-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.65', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '4.16'}, {'value': '3.31', 'groupId': 'OG001', 'lowerLimit': '2.91', 'upperLimit': '3.76'}, {'value': '3.68', 'groupId': 'OG002', 'lowerLimit': '3.15', 'upperLimit': '4.30'}, {'value': '3.07', 'groupId': 'OG003', 'lowerLimit': '2.83', 'upperLimit': '3.34'}]}]}, {'title': 'ANTI-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '0.73'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '0.83'}, {'value': '0.72', 'groupId': 'OG002', 'lowerLimit': '0.61', 'upperLimit': '0.86'}, {'value': '1.59', 'groupId': 'OG003', 'lowerLimit': '1.38', 'upperLimit': '1.84'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.90', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.07', 'groupDescription': 'ANTI-1 serotype test :to demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.51 in the 11Pn Group and N= 203 and Adjusted GMC= 1.36 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.94', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.14', 'groupDescription': 'ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.77 in the 11Pn Group and N= 203 and Adjusted GMC= 1.66 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.88', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.03', 'groupDescription': 'ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 2.46 in the 11Pn Group and N= 201 and Adjusted GMC= 2.16 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.93', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.23', 'groupDescription': 'ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =0.51 in the 11Pn Group and N= 200 and Adjusted GMC= 0.47 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.94', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.10', 'groupDescription': 'ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=219 and Adjusted GMC =2.30 in the 11Pn Group and N= 202 and Adjusted GMC= 2.17 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.89', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.06', 'groupDescription': 'ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.56 in the 11Pn Group and N= 200 and Adjusted GMC= 1.40 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.96', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.15', 'groupDescription': 'ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 4.22 in the 11Pn Group and N= 201 and Adjusted GMC= 4.06 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.92', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.14', 'groupDescription': 'ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =2.81 in the 11Pn Group and N= 201 and Adjusted GMC= 2.57 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '1.0', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.23', 'groupDescription': 'ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 3.70 in the 11Pn Group and N= 202 and Adjusted GMC= 3.68 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '1.15', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.48', 'groupDescription': 'ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 0.62 in the 11Pn Group and N= 199 and Adjusted GMC= 0.71 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '1.71', 'ciLowerLimit': '1.44', 'ciUpperLimit': '2.03', 'groupDescription': 'ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \\< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations/titres, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=217 and Adjusted GMC =1.61 in the 11Pn Group and N= 206 and Adjusted GMC= 2.75 for the Prevnar13 Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciPctValue': '95.8', 'paramValue': '0.86', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.02', 'groupDescription': 'ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=207 and Adj. GMC =1.58 in 12Pn Group and N= 203 and Adj. GMC= 1.35 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciPctValue': '95.8', 'paramValue': '0.86', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.05', 'groupDescription': 'ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.94 in 12Pn Group and N= 203 and Adj. GMC= 1.66 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '0.91', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.07', 'groupDescription': 'ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =2.37 in 12Pn Group and N= 201 and Adj. GMC= 2.16 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciPctValue': '95.8', 'paramValue': '0.84', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.11', 'groupDescription': 'ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.56 in 12Pn Group and N= 200 and Adj. GMC= 0.47 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '0.90', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.06', 'groupDescription': 'ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =2.42 in 12Pn Group and N= 202 and Adj. GMC= 2.17 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '0.79', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.93', 'groupDescription': 'ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.78 in 12Pn Group and N= 200 and Adj. GMC= 1.40 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '0.91', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.09', 'groupDescription': 'ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =4.48 in 12Pn Group and N= 201 and Adj. GMC= 4.10 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '1.01', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.26', 'groupDescription': 'ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =2.55 in 12Pn Group and N= 201 and Adj. GMC= 2.57 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '1.12', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.38', 'groupDescription': 'ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =3.29 in 12Pn Group and N= 202 and Adj. GMC= 3.67 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '1.05', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.37', 'groupDescription': 'ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.68 in 12Pn Group and N= 199 and Adj. GMC= 0.71 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI..'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '1.90', 'ciLowerLimit': '1.51', 'ciUpperLimit': '2.39', 'groupDescription': 'ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=210 and Adj. GMC =1.09 in 12Pn Group and N= 214 and Adj. GMC= 2.07 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted GMCs ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '2.32', 'ciLowerLimit': '1.94', 'ciUpperLimit': '2.77', 'groupDescription': 'ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \\< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.19 in 12Pn Group and N= 206 and Adj. GMC= 2.76 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3).', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.'}, {'type': 'PRIMARY', 'title': 'Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'ANTI-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}, {'value': '98.6', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}, {'value': '96.7', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}, {'value': '75.2', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '99.0', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '98.1', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '97.6', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '-0.98', 'ciLowerLimit': '-3.89', 'ciUpperLimit': '1.36', 'groupDescription': 'ANTI-1 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '-1.08', 'ciLowerLimit': '-4.94', 'ciUpperLimit': '2.45', 'groupDescription': 'ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9% Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '-0.48', 'ciLowerLimit': '-2.82', 'ciUpperLimit': '1.38', 'groupDescription': 'ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '-2.24', 'ciLowerLimit': '-10.65', 'ciUpperLimit': '6.13', 'groupDescription': 'ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '-0.03', 'ciLowerLimit': '-2.39', 'ciUpperLimit': '2.21', 'groupDescription': 'ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.40', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '3.22', 'groupDescription': 'ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.45', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '2.66', 'groupDescription': 'ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '-1.00', 'ciLowerLimit': '-4.18', 'ciUpperLimit': '1.70', 'groupDescription': 'ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '-2.38', 'ciLowerLimit': '-5.64', 'ciUpperLimit': '-0.52', 'groupDescription': 'ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '2.73', 'ciLowerLimit': '-4.84', 'ciUpperLimit': '10.25', 'groupDescription': 'ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month post-dose 3 (primary phase)', 'description': 'N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine 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). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.'}, {'type': 'PRIMARY', 'title': 'Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.9', 'paramValue': '0.89', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '3.66', 'groupDescription': 'ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \\< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe, 1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month post-dose 3 (primary phase)', 'description': 'N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.'}, {'type': 'PRIMARY', 'title': 'Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'ANTI-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '98.6', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}, {'value': '96.7', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000'}, {'value': '75.2', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '99.0', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '98.1', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '97.6', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '-0.49', 'ciLowerLimit': '-3.44', 'ciUpperLimit': '2.22', 'groupDescription': 'ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '-0.06', 'ciLowerLimit': '-4.03', 'ciUpperLimit': '3.86', 'groupDescription': 'ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '-0.01', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '2.30', 'groupDescription': 'ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '-4.67', 'ciLowerLimit': '-12.94', 'ciUpperLimit': '3.60', 'groupDescription': 'ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '0.46', 'ciLowerLimit': '-1.93', 'ciUpperLimit': '3.06', 'groupDescription': 'ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '-0.02', 'ciLowerLimit': '-2.72', 'ciUpperLimit': '2.64', 'groupDescription': 'ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '0.00', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '1.90', 'groupDescription': 'ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '-0.50', 'ciLowerLimit': '-3.72', 'ciUpperLimit': '2.52', 'groupDescription': 'ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '-0.98', 'ciLowerLimit': '-4.38', 'ciUpperLimit': '2.10', 'groupDescription': 'ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '2.50', 'ciLowerLimit': '-5.07', 'ciUpperLimit': '10.06', 'groupDescription': 'ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month post-dose 3 (primary phase)', 'description': 'N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine 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). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.'}, {'type': 'PRIMARY', 'title': 'Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'ANTI-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}, {'title': 'ANTI-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '11.22', 'ciLowerLimit': '7.22', 'ciUpperLimit': '16.49', 'groupDescription': 'ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\<10% for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.8', 'paramValue': '3.75', 'ciLowerLimit': '1.03', 'ciUpperLimit': '7.57', 'groupDescription': 'ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \\& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \\<10% for at least 10 out of 12 vaccine pneumococcal serotypes.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \\[Newcombe,1998\\]. The standardized asymptotic method used within GSK Biologicals is method 6.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month post-dose 3 (primary phase)', 'description': 'N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}, {'value': '210', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'ANTI-1 (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '210', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.30'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.30'}, {'value': '0.26', 'groupId': 'OG002', 'lowerLimit': '0.23', 'upperLimit': '0.29'}, {'value': '0.44', 'groupId': 'OG003', 'lowerLimit': '0.40', 'upperLimit': '0.48'}]}]}, {'title': 'ANTI-1 (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.49', 'groupId': 'OG000', 'lowerLimit': '2.21', 'upperLimit': '2.82'}, {'value': '2.18', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': '2.46'}, {'value': '2.25', 'groupId': 'OG002', 'lowerLimit': '2.01', 'upperLimit': '2.53'}, {'value': '3.84', 'groupId': 'OG003', 'lowerLimit': '3.50', 'upperLimit': '4.22'}]}]}, {'title': 'ANTI-3 (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.07'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.06'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.07'}, {'value': '0.25', 'groupId': 'OG003', 'lowerLimit': '0.22', 'upperLimit': '0.29'}]}]}, {'title': 'ANTI-3 (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.08'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.08'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0.06', 'upperLimit': '0.09'}, {'value': '1.68', 'groupId': 'OG003', 'lowerLimit': '1.53', 'upperLimit': '1.85'}]}]}, {'title': 'ANTI-4 (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}, {'value': '210', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '0.54'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '0.54'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '0.45', 'upperLimit': '0.56'}, {'value': '0.41', 'groupId': 'OG003', 'lowerLimit': '0.37', 'upperLimit': '0.46'}]}]}, {'title': 'ANTI-4 (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.89', 'groupId': 'OG000', 'lowerLimit': '3.49', 'upperLimit': '4.34'}, {'value': '4.18', 'groupId': 'OG001', 'lowerLimit': '3.77', 'upperLimit': '4.63'}, {'value': '4.06', 'groupId': 'OG002', 'lowerLimit': '3.70', 'upperLimit': '4.45'}, {'value': '3.86', 'groupId': 'OG003', 'lowerLimit': '3.43', 'upperLimit': '4.35'}]}]}, {'title': 'ANTI-5 (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '0.57'}, {'value': '0.51', 'groupId': 'OG001', 'lowerLimit': '0.45', 'upperLimit': '0.57'}, {'value': '0.48', 'groupId': 'OG002', 'lowerLimit': '0.43', 'upperLimit': '0.53'}, {'value': '0.77', 'groupId': 'OG003', 'lowerLimit': '0.69', 'upperLimit': '0.85'}]}]}, {'title': 'ANTI-5 (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.23', 'groupId': 'OG000', 'lowerLimit': '2.88', 'upperLimit': '3.64'}, {'value': '3.31', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '3.68'}, {'value': '3.05', 'groupId': 'OG002', 'lowerLimit': '2.75', 'upperLimit': '3.38'}, {'value': '6.84', 'groupId': 'OG003', 'lowerLimit': '6.12', 'upperLimit': '7.66'}]}]}, {'title': 'ANTI-6B (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.65'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.56', 'upperLimit': '0.74'}, {'value': '0.59', 'groupId': 'OG002', 'lowerLimit': '0.51', 'upperLimit': '0.69'}, {'value': '0.22', 'groupId': 'OG003', 'lowerLimit': '0.19', 'upperLimit': '0.25'}]}]}, {'title': 'ANTI-6B (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.66', 'groupId': 'OG000', 'lowerLimit': '2.34', 'upperLimit': '3.03'}, {'value': '4.09', 'groupId': 'OG001', 'lowerLimit': '3.60', 'upperLimit': '4.66'}, {'value': '2.53', 'groupId': 'OG002', 'lowerLimit': '2.24', 'upperLimit': '2.86'}, {'value': '3.80', 'groupId': 'OG003', 'lowerLimit': '3.34', 'upperLimit': '4.33'}]}]}, {'title': 'ANTI-7F (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.16'}, {'value': '0.99', 'groupId': 'OG001', 'lowerLimit': '0.89', 'upperLimit': '1.10'}, {'value': '0.94', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '1.05'}, {'value': '1.21', 'groupId': 'OG003', 'lowerLimit': '1.11', 'upperLimit': '1.32'}]}]}, {'title': 'ANTI-7F (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.88', 'groupId': 'OG000', 'lowerLimit': '4.40', 'upperLimit': '5.40'}, {'value': '4.57', 'groupId': 'OG001', 'lowerLimit': '4.14', 'upperLimit': '5.04'}, {'value': '4.31', 'groupId': 'OG002', 'lowerLimit': '3.91', 'upperLimit': '4.75'}, {'value': '6.34', 'groupId': 'OG003', 'lowerLimit': '5.80', 'upperLimit': '6.95'}]}]}, {'title': 'ANTI-9V (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '0.85'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '0.87'}, {'value': '0.70', 'groupId': 'OG002', 'lowerLimit': '0.63', 'upperLimit': '0.77'}, {'value': '0.53', 'groupId': 'OG003', 'lowerLimit': '0.48', 'upperLimit': '0.58'}]}]}, {'title': 'ANTI-9V (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.14', 'groupId': 'OG000', 'lowerLimit': '3.70', 'upperLimit': '4.62'}, {'value': '4.36', 'groupId': 'OG001', 'lowerLimit': '3.93', 'upperLimit': '4.84'}, {'value': '3.68', 'groupId': 'OG002', 'lowerLimit': '3.32', 'upperLimit': '4.09'}, {'value': '5.83', 'groupId': 'OG003', 'lowerLimit': '5.26', 'upperLimit': '6.46'}]}]}, {'title': 'ANTI-14 (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000', 'lowerLimit': '1.11', 'upperLimit': '1.53'}, {'value': '1.45', 'groupId': 'OG001', 'lowerLimit': '1.28', 'upperLimit': '1.64'}, {'value': '1.12', 'groupId': 'OG002', 'lowerLimit': '0.97', 'upperLimit': '1.30'}, {'value': '1.66', 'groupId': 'OG003', 'lowerLimit': '1.44', 'upperLimit': '1.93'}]}]}, {'title': 'ANTI-14 (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.17', 'groupId': 'OG000', 'lowerLimit': '5.45', 'upperLimit': '6.98'}, {'value': '6.52', 'groupId': 'OG001', 'lowerLimit': '5.80', 'upperLimit': '7.33'}, {'value': '5.75', 'groupId': 'OG002', 'lowerLimit': '5.07', 'upperLimit': '6.51'}, {'value': '10.05', 'groupId': 'OG003', 'lowerLimit': '8.97', 'upperLimit': '11.25'}]}]}, {'title': 'ANTI-18C (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '0.86'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.60', 'upperLimit': '0.77'}, {'value': '0.74', 'groupId': 'OG002', 'lowerLimit': '0.65', 'upperLimit': '0.84'}, {'value': '0.59', 'groupId': 'OG003', 'lowerLimit': '0.54', 'upperLimit': '0.65'}]}]}, {'title': 'ANTI-18C (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.65', 'groupId': 'OG000', 'lowerLimit': '6.79', 'upperLimit': '8.61'}, {'value': '7.20', 'groupId': 'OG001', 'lowerLimit': '6.39', 'upperLimit': '8.11'}, {'value': '8.00', 'groupId': 'OG002', 'lowerLimit': '7.06', 'upperLimit': '9.06'}, {'value': '6.01', 'groupId': 'OG003', 'lowerLimit': '5.45', 'upperLimit': '6.63'}]}]}, {'title': 'ANTI-19A (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.54'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.31', 'upperLimit': '0.42'}, {'value': '0.18', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.21'}, {'value': '0.42', 'groupId': 'OG003', 'lowerLimit': '0.35', 'upperLimit': '0.49'}]}]}, {'title': 'ANTI-19A (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.35', 'groupId': 'OG000', 'lowerLimit': '4.67', 'upperLimit': '6.13'}, {'value': '4.46', 'groupId': 'OG001', 'lowerLimit': '3.83', 'upperLimit': '5.20'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '0.91', 'upperLimit': '1.35'}, {'value': '7.06', 'groupId': 'OG003', 'lowerLimit': '6.25', 'upperLimit': '7.98'}]}]}, {'title': 'ANTI-19F (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.11', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.28'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '1.29'}, {'value': '1.10', 'groupId': 'OG002', 'lowerLimit': '0.95', 'upperLimit': '1.29'}, {'value': '0.50', 'groupId': 'OG003', 'lowerLimit': '0.44', 'upperLimit': '0.57'}]}]}, {'title': 'ANTI-19F (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.67', 'groupId': 'OG000', 'lowerLimit': '7.72', 'upperLimit': '9.73'}, {'value': '8.50', 'groupId': 'OG001', 'lowerLimit': '7.55', 'upperLimit': '9.59'}, {'value': '8.22', 'groupId': 'OG002', 'lowerLimit': '7.40', 'upperLimit': '9.13'}, {'value': '6.40', 'groupId': 'OG003', 'lowerLimit': '5.77', 'upperLimit': '7.11'}]}]}, {'title': 'ANTI-23F (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '0.58'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.47', 'upperLimit': '0.62'}, {'value': '0.49', 'groupId': 'OG002', 'lowerLimit': '0.43', 'upperLimit': '0.56'}, {'value': '0.34', 'groupId': 'OG003', 'lowerLimit': '0.29', 'upperLimit': '0.39'}]}]}, {'title': 'ANTI-23F (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.09', 'groupId': 'OG000', 'lowerLimit': '2.73', 'upperLimit': '3.49'}, {'value': '3.31', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '3.73'}, {'value': '2.98', 'groupId': 'OG002', 'lowerLimit': '2.65', 'upperLimit': '3.35'}, {'value': '6.49', 'groupId': 'OG003', 'lowerLimit': '5.69', 'upperLimit': '7.39'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine', 'description': 'Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'OPA-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '18.2'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '21.1'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '9.9', 'upperLimit': '18.6'}, {'value': '26.4', 'groupId': 'OG003', 'lowerLimit': '19.3', 'upperLimit': '36.0'}]}]}, {'title': 'OPA-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '5.5'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '6.0'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '5.7'}, {'value': '97.2', 'groupId': 'OG003', 'lowerLimit': '81.6', 'upperLimit': '116.0'}]}]}, {'title': 'OPA-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '527.3', 'groupId': 'OG000', 'lowerLimit': '401.5', 'upperLimit': '692.4'}, {'value': '609.0', 'groupId': 'OG001', 'lowerLimit': '492.8', 'upperLimit': '752.5'}, {'value': '616.7', 'groupId': 'OG002', 'lowerLimit': '503.2', 'upperLimit': '756.0'}, {'value': '540.1', 'groupId': 'OG003', 'lowerLimit': '444.7', 'upperLimit': '656.1'}]}]}, {'title': 'OPA-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000', 'lowerLimit': '32.6', 'upperLimit': '56.9'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '36.8', 'upperLimit': '59.3'}, {'value': '40.5', 'groupId': 'OG002', 'lowerLimit': '30.4', 'upperLimit': '54.0'}, {'value': '57.2', 'groupId': 'OG003', 'lowerLimit': '44.3', 'upperLimit': '74.0'}]}]}, {'title': 'OPA-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '60.9'}, {'value': '1292.6', 'groupId': 'OG001', 'lowerLimit': '940.3', 'upperLimit': '1777.0'}, {'value': '36.5', 'groupId': 'OG002', 'lowerLimit': '22.6', 'upperLimit': '59.0'}, {'value': '2832.0', 'groupId': 'OG003', 'lowerLimit': '2212.8', 'upperLimit': '3624.4'}]}]}, {'title': 'OPA-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '478.3', 'groupId': 'OG000', 'lowerLimit': '345.2', 'upperLimit': '662.7'}, {'value': '603.2', 'groupId': 'OG001', 'lowerLimit': '436.9', 'upperLimit': '832.8'}, {'value': '622.6', 'groupId': 'OG002', 'lowerLimit': '444.2', 'upperLimit': '872.7'}, {'value': '742.3', 'groupId': 'OG003', 'lowerLimit': '533.9', 'upperLimit': '1031.8'}]}]}, {'title': 'OPA-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3515.0', 'groupId': 'OG000', 'lowerLimit': '2787.1', 'upperLimit': '4433.0'}, {'value': '4472.3', 'groupId': 'OG001', 'lowerLimit': '3463.6', 'upperLimit': '5774.9'}, {'value': '3424.1', 'groupId': 'OG002', 'lowerLimit': '2631.9', 'upperLimit': '4454.8'}, {'value': '9737.9', 'groupId': 'OG003', 'lowerLimit': '7540.5', 'upperLimit': '12575.8'}]}]}, {'title': 'OPA-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1212.9', 'groupId': 'OG000', 'lowerLimit': '953.6', 'upperLimit': '1542.6'}, {'value': '1629.0', 'groupId': 'OG001', 'lowerLimit': '1293.0', 'upperLimit': '2052.4'}, {'value': '1469.9', 'groupId': 'OG002', 'lowerLimit': '1178.3', 'upperLimit': '1833.6'}, {'value': '1614.5', 'groupId': 'OG003', 'lowerLimit': '1283.9', 'upperLimit': '2030.2'}]}]}, {'title': 'OPA-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1000.8', 'groupId': 'OG000', 'lowerLimit': '743.1', 'upperLimit': '1347.9'}, {'value': '1699.1', 'groupId': 'OG001', 'lowerLimit': '1313.8', 'upperLimit': '2197.3'}, {'value': '1417.4', 'groupId': 'OG002', 'lowerLimit': '1059.6', 'upperLimit': '1896.0'}, {'value': '2034.4', 'groupId': 'OG003', 'lowerLimit': '1513.4', 'upperLimit': '2734.8'}]}]}, {'title': 'OPA-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.9', 'groupId': 'OG000', 'lowerLimit': '67.7', 'upperLimit': '150.4'}, {'value': '131.5', 'groupId': 'OG001', 'lowerLimit': '86.9', 'upperLimit': '198.8'}, {'value': '72.0', 'groupId': 'OG002', 'lowerLimit': '47.0', 'upperLimit': '110.4'}, {'value': '145.7', 'groupId': 'OG003', 'lowerLimit': '102.6', 'upperLimit': '206.8'}]}]}, {'title': 'OPA-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '144.2', 'groupId': 'OG000', 'lowerLimit': '101.8', 'upperLimit': '204.3'}, {'value': '201.4', 'groupId': 'OG001', 'lowerLimit': '147.2', 'upperLimit': '275.4'}, {'value': '210.4', 'groupId': 'OG002', 'lowerLimit': '143.6', 'upperLimit': '308.2'}, {'value': '66.0', 'groupId': 'OG003', 'lowerLimit': '49.8', 'upperLimit': '87.5'}]}]}, {'title': 'OPA-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '989.6', 'groupId': 'OG000', 'lowerLimit': '652.9', 'upperLimit': '1499.8'}, {'value': '1377.9', 'groupId': 'OG001', 'lowerLimit': '951.5', 'upperLimit': '1995.3'}, {'value': '1097.3', 'groupId': 'OG002', 'lowerLimit': '742.1', 'upperLimit': '1622.4'}, {'value': '5136.4', 'groupId': 'OG003', 'lowerLimit': '3829.2', 'upperLimit': '6889.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'OPA-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '192.4', 'groupId': 'OG000', 'lowerLimit': '129.0', 'upperLimit': '287.1'}, {'value': '192.4', 'groupId': 'OG001', 'lowerLimit': '133.3', 'upperLimit': '277.5'}, {'value': '216.8', 'groupId': 'OG002', 'lowerLimit': '148.3', 'upperLimit': '316.9'}, {'value': '207.6', 'groupId': 'OG003', 'lowerLimit': '145.8', 'upperLimit': '295.6'}]}]}, {'title': 'OPA-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '12.7'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '13.7'}, {'value': '10.9', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '15.5'}, {'value': '317.2', 'groupId': 'OG003', 'lowerLimit': '275.4', 'upperLimit': '365.4'}]}]}, {'title': 'OPA-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1455.3', 'groupId': 'OG000', 'lowerLimit': '1208.9', 'upperLimit': '1751.9'}, {'value': '1650.5', 'groupId': 'OG001', 'lowerLimit': '1360.9', 'upperLimit': '2001.9'}, {'value': '1550.5', 'groupId': 'OG002', 'lowerLimit': '1230.2', 'upperLimit': '1954.1'}, {'value': '1972.2', 'groupId': 'OG003', 'lowerLimit': '1586.3', 'upperLimit': '2451.9'}]}]}, {'title': 'OPA-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '134.5', 'groupId': 'OG000', 'lowerLimit': '100.3', 'upperLimit': '180.4'}, {'value': '133.3', 'groupId': 'OG001', 'lowerLimit': '105.2', 'upperLimit': '168.8'}, {'value': '133.4', 'groupId': 'OG002', 'lowerLimit': '100.5', 'upperLimit': '177.1'}, {'value': '269.9', 'groupId': 'OG003', 'lowerLimit': '216.2', 'upperLimit': '337.0'}]}]}, {'title': 'OPA-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '116.8', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '201.0'}, {'value': '3436.7', 'groupId': 'OG001', 'lowerLimit': '2716.0', 'upperLimit': '4348.5'}, {'value': '146.4', 'groupId': 'OG002', 'lowerLimit': '87.6', 'upperLimit': '244.6'}, {'value': '5200.7', 'groupId': 'OG003', 'lowerLimit': '4134.9', 'upperLimit': '6541.3'}]}]}, {'title': 'OPA-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '681.4', 'groupId': 'OG000', 'lowerLimit': '520.3', 'upperLimit': '892.5'}, {'value': '1246.4', 'groupId': 'OG001', 'lowerLimit': '963.1', 'upperLimit': '1613.0'}, {'value': '694.6', 'groupId': 'OG002', 'lowerLimit': '546.5', 'upperLimit': '882.6'}, {'value': '1727.9', 'groupId': 'OG003', 'lowerLimit': '1406.2', 'upperLimit': '2123.4'}]}]}, {'title': 'OPA-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8362.9', 'groupId': 'OG000', 'lowerLimit': '6977.1', 'upperLimit': '10023.9'}, {'value': '7516.4', 'groupId': 'OG001', 'lowerLimit': '6223.0', 'upperLimit': '9078.7'}, {'value': '7880.8', 'groupId': 'OG002', 'lowerLimit': '6408.6', 'upperLimit': '9691.3'}, {'value': '16592.6', 'groupId': 'OG003', 'lowerLimit': '13909.7', 'upperLimit': '19792.9'}]}]}, {'title': 'OPA-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3406.9', 'groupId': 'OG000', 'lowerLimit': '2758.2', 'upperLimit': '4208.1'}, {'value': '3616.1', 'groupId': 'OG001', 'lowerLimit': '2838.1', 'upperLimit': '4607.5'}, {'value': '3260.6', 'groupId': 'OG002', 'lowerLimit': '2620.1', 'upperLimit': '4057.6'}, {'value': '8470.4', 'groupId': 'OG003', 'lowerLimit': '6692.4', 'upperLimit': '10720.8'}]}]}, {'title': 'OPA-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2038.4', 'groupId': 'OG000', 'lowerLimit': '1594.3', 'upperLimit': '2606.2'}, {'value': '2519.9', 'groupId': 'OG001', 'lowerLimit': '1960.2', 'upperLimit': '3239.6'}, {'value': '2285.1', 'groupId': 'OG002', 'lowerLimit': '1845.9', 'upperLimit': '2828.9'}, {'value': '2772.6', 'groupId': 'OG003', 'lowerLimit': '2218.6', 'upperLimit': '3464.9'}]}]}, {'title': 'OPA-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '914.8', 'groupId': 'OG000', 'lowerLimit': '621.8', 'upperLimit': '1345.9'}, {'value': '781.2', 'groupId': 'OG001', 'lowerLimit': '536.3', 'upperLimit': '1137.8'}, {'value': '912.0', 'groupId': 'OG002', 'lowerLimit': '605.4', 'upperLimit': '1374.1'}, {'value': '610.7', 'groupId': 'OG003', 'lowerLimit': '421.3', 'upperLimit': '885.1'}]}]}, {'title': 'OPA-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '523.9', 'groupId': 'OG000', 'lowerLimit': '382.9', 'upperLimit': '716.8'}, {'value': '565.3', 'groupId': 'OG001', 'lowerLimit': '406.4', 'upperLimit': '786.6'}, {'value': '759.6', 'groupId': 'OG002', 'lowerLimit': '554.3', 'upperLimit': '1040.8'}, {'value': '438.0', 'groupId': 'OG003', 'lowerLimit': '312.7', 'upperLimit': '613.7'}]}]}, {'title': 'OPA-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2562.9', 'groupId': 'OG000', 'lowerLimit': '2016.3', 'upperLimit': '3257.6'}, {'value': '2923.6', 'groupId': 'OG001', 'lowerLimit': '2248.9', 'upperLimit': '3800.9'}, {'value': '2600.0', 'groupId': 'OG002', 'lowerLimit': '1896.8', 'upperLimit': '3563.9'}, {'value': '24350.4', 'groupId': 'OG003', 'lowerLimit': '18303.2', 'upperLimit': '32395.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine', 'description': 'Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).'}], 'classes': [{'categories': [{'measurements': [{'value': '1430.1', 'groupId': 'OG000', 'lowerLimit': '1194.2', 'upperLimit': '1712.7'}, {'value': '1194.2', 'groupId': 'OG001', 'lowerLimit': '1017.7', 'upperLimit': '1401.3'}, {'value': '1344.8', 'groupId': 'OG002', 'lowerLimit': '1116.4', 'upperLimit': '1619.9'}, {'value': '64.4', 'groupId': 'OG003', 'lowerLimit': '57.7', 'upperLimit': '71.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'Anti-PD (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '445.9', 'groupId': 'OG000', 'lowerLimit': '365.0', 'upperLimit': '544.7'}, {'value': '447.6', 'groupId': 'OG001', 'lowerLimit': '363.4', 'upperLimit': '551.2'}, {'value': '460.0', 'groupId': 'OG002', 'lowerLimit': '376.2', 'upperLimit': '562.4'}, {'value': '70.9', 'groupId': 'OG003', 'lowerLimit': '61.8', 'upperLimit': '81.3'}]}]}, {'title': 'Anti-PD (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1866.0', 'groupId': 'OG000', 'lowerLimit': '1535.7', 'upperLimit': '2267.4'}, {'value': '1835.5', 'groupId': 'OG001', 'lowerLimit': '1511.5', 'upperLimit': '2229.0'}, {'value': '2128.4', 'groupId': 'OG002', 'lowerLimit': '1777.1', 'upperLimit': '2549.2'}, {'value': '77.8', 'groupId': 'OG003', 'lowerLimit': '67.1', 'upperLimit': '90.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine', 'description': 'Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).'}], 'classes': [{'title': 'Any Pain, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any Pain, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any Pain, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).', 'description': 'Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\\>) 30 millimeters (mm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 4-day (Days 0-3) period after booster vaccination', 'description': 'Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\\>) 30 millimeters (mm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).'}], 'classes': [{'title': 'Any Drowsiness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Drowsiness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Related Drowsiness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}]}, {'title': 'Any Irr./Fuss., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Irr./Fuss., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Related Irr./Fuss., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss Appet., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Loss Appet., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Related Loss Appet., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fever, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Fever, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '238', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'Any Drowsiness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Drowsiness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Related Drowsiness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}]}, {'title': 'Any Irr./Fuss., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Irr./Fuss., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Related Irr./Fuss., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss Appet., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Loss Appet., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Related Loss Appet., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fever, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Fever, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}, {'title': 'Any Drowsiness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Drowsiness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Related Drowsiness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}]}, {'title': 'Any Irr./Fuss., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Irr./Fuss., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Related Irr./Fuss., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss Appet., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Loss Appet., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Related Loss Appet., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fever, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Fever, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).', 'description': 'Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \\[≥\\] 38.0 degrees Celsius \\[°C\\]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\\>) 40.0°C.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Related Drowsiness', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}]}, {'title': 'Any Irr./Fuss.', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Irr./Fuss.', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Related Irr./Fuss.', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss Appet.', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Loss Appet.', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Related Loss Appet.', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever.', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Fever', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 4-day (Days 0-3) period after booster vaccination', 'description': 'Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \\[≥\\] 38.0 degrees Celsius \\[°C\\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\\>) 40.0°C.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}, {'value': '241', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 31-day (Days 0-30) period post primary vaccination, across doses', 'description': 'An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 31-day (Days 0-30) period post booster vaccination', 'description': 'An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}, {'value': '241', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 to Month 3', 'description': 'A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}, {'value': '241', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 11', 'description': 'A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'title': 'ANTI-6A (M10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '0.27'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '1.01'}, {'value': '0.22', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '0.26'}, {'value': '0.64', 'groupId': 'OG003', 'lowerLimit': '0.56', 'upperLimit': '0.73'}]}]}, {'title': 'ANTI-6A (M11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.27'}, {'value': '7.94', 'groupId': 'OG001', 'lowerLimit': '6.99', 'upperLimit': '9.02'}, {'value': '0.91', 'groupId': 'OG002', 'lowerLimit': '0.76', 'upperLimit': '1.09'}, {'value': '9.31', 'groupId': 'OG003', 'lowerLimit': '8.41', 'upperLimit': '10.30'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine', 'description': 'Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'categories': [{'measurements': [{'value': '1813.0', 'groupId': 'OG000', 'lowerLimit': '1524.4', 'upperLimit': '2156.1'}, {'value': '1523.9', 'groupId': 'OG001', 'lowerLimit': '1215.3', 'upperLimit': '1910.9'}, {'value': '759.6', 'groupId': 'OG002', 'lowerLimit': '559.2', 'upperLimit': '1032.0'}, {'value': '2056.6', 'groupId': 'OG003', 'lowerLimit': '1748.9', 'upperLimit': '2418.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'classes': [{'categories': [{'measurements': [{'value': '4866.4', 'groupId': 'OG000', 'lowerLimit': '4184.6', 'upperLimit': '5659.4'}, {'value': '3896.4', 'groupId': 'OG001', 'lowerLimit': '3263.2', 'upperLimit': '4652.4'}, {'value': '2191.0', 'groupId': 'OG002', 'lowerLimit': '1720.0', 'upperLimit': '2791.0'}, {'value': '5720.1', 'groupId': 'OG003', 'lowerLimit': '4883.9', 'upperLimit': '6699.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine', 'description': 'Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase. But no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'timeFrame': 'At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine', 'description': 'No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'OG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'timeFrame': 'At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine', 'description': 'No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'FG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'FG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'FG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '230'}, {'groupId': 'FG003', 'numSubjects': '241'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '223'}, {'groupId': 'FG002', 'numSubjects': '220'}, {'groupId': 'FG003', 'numSubjects': '233'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '953 subjects were enrolled in the study, among whom 951 received at least one dose of study vaccine, while 2 were allocated a subject number but did not receive any study vaccine dose.', 'preAssignmentDetails': 'Study vaccines were administered as a 3-dose primary vaccination in healthy infants between 6-12 weeks (42-90 days) of age at the time of the first vaccination (Primary Phase), and then as an additional booster dose when subjects reached 12-15 months of age (Booster Phase).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '241', 'groupId': 'BG003'}, {'value': '951', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'BG001', 'title': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'BG002', 'title': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).'}, {'id': 'BG003', 'title': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.49', 'groupId': 'BG000'}, {'value': '8.7', 'spread': '1.61', 'groupId': 'BG001'}, {'value': '8.7', 'spread': '1.62', 'groupId': 'BG002'}, {'value': '8.6', 'spread': '1.54', 'groupId': 'BG003'}, {'value': '8.6', 'spread': '1.56', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}, {'value': '467', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}, {'value': '484', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 953}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2013-08-22', 'completionDateStruct': {'date': '2014-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2012-06-07', 'dispFirstSubmitQcDate': '2013-08-22', 'resultsFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2012-06-07', 'dispFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-15', 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3).'}, {'measure': 'Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes', 'timeFrame': '1 month post-dose 3 (primary phase)', 'description': 'N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine 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). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype', 'timeFrame': '1 month post-dose 3 (primary phase)', 'description': 'N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes', 'timeFrame': '1 month post-dose 3 (primary phase)', 'description': 'N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine 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). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes', 'timeFrame': '1 month post-dose 3 (primary phase)', 'description': 'N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).'}], 'secondaryOutcomes': [{'measure': 'Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study', 'timeFrame': 'At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine', 'description': 'Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study', 'timeFrame': 'At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine', 'description': 'Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.'}, {'measure': 'Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.'}, {'measure': 'Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study', 'timeFrame': 'At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine', 'description': 'Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase', 'timeFrame': 'Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).', 'description': 'Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\\>) 30 millimeters (mm).'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study', 'timeFrame': 'Within the 4-day (Days 0-3) period after booster vaccination', 'description': 'Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\\>) 30 millimeters (mm).'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study', 'timeFrame': 'Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).', 'description': 'Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \\[≥\\] 38.0 degrees Celsius \\[°C\\]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\\>) 40.0°C.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study', 'timeFrame': 'Within the 4-day (Days 0-3) period after booster vaccination', 'description': 'Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \\[≥\\] 38.0 degrees Celsius \\[°C\\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\\>) 40.0°C.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study', 'timeFrame': 'Within the 31-day (Days 0-30) period post primary vaccination, across doses', 'description': 'An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study', 'timeFrame': 'Within the 31-day (Days 0-30) period post booster vaccination', 'description': 'An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.'}, {'measure': 'Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study', 'timeFrame': 'From Month 0 to Month 3', 'description': 'A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.'}, {'measure': 'Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study', 'timeFrame': 'From Day 0 to Month 11', 'description': 'A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study', 'timeFrame': 'At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine', 'description': 'Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study', 'timeFrame': 'At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine', 'description': 'Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study.', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study.', 'timeFrame': 'At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine', 'description': 'No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study', 'timeFrame': 'At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine', 'description': 'No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study', 'timeFrame': 'At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine', 'description': 'No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Streptococcus pneumoniae', 'Haemophilus influenzae', 'Pneumococcal vaccine', 'Infants', 'Safety', 'Immunogenicity'], 'conditions': ['Infections, Streptococcal']}, 'referencesModule': {'references': [{'pmid': '30054160', 'type': 'BACKGROUND', 'citation': 'Carmona Martinez A, Prymula R, Miranda Valdivieso M, Otero Reigada MDC, Merino Arribas JM, Brzostek J, Szenborn L, Ruzkova R, Horn MR, Jackowska T, Centeno-Malfaz F, Traskine M, Dobbelaere K, Borys D. Immunogenicity and safety of 11- and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study. Vaccine. 2019 Jan 3;37(1):176-186. doi: 10.1016/j.vaccine.2018.07.023. Epub 2018 Jul 24.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.", 'detailedDescription': "The purpose of this study is to assess the immunogenicity of the two formulations of GSK Biologicals' pneumococcal vaccine 2830929A (11-valent vaccine or 11Pn vaccine) and 2830930A (12-valent vaccine or 12Pn vaccine), when administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life, when compared to immune responses to the licensed vaccines Synflorix™ and Prevnar 13™, and to assess the reactogenicity and safety of these two same investigational formulations when administered according to this schedule. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine will be co-administered in infants with the pneumococcal study vaccines."}, '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 parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.\n* A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. In addition, the first pneumococcal and DTPa-HBV-IPV/Hib vaccination should be given in accordance with the official national recommendations for the immunisation schedule of infants.\n* Written informed consent obtained from the parents/LAR(s) of the subject.\n* Healthy subjects 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* Child in care.\n* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.\n* Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions:\n\n * Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines.\n * Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines.\n * Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12-15 months of age.\n * In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by the public health authorities, outside the routine immunization program, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Family history of congenital or hereditary immunodeficiency.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).\n* Major congenital defects or serious chronic illness, including Kawasaki's syndrome.\n* History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).\n* Acute disease and/or fever at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during study period.\n* Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b.\n* Previous vaccination against S. pneumoniae.\n* History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease.\n* Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator."}, 'identificationModule': {'nctId': 'NCT01616459', 'briefTitle': "Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants", 'orgStudyIdInfo': {'id': '116485'}, 'secondaryIdInfos': [{'id': '2011-005743-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '11Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).', 'interventionNames': ['Biological: Pneumococcal conjugate vaccine GSK2830929A', 'Biological: Infanrix hexa™']}, {'type': 'EXPERIMENTAL', 'label': '12Pn Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).', 'interventionNames': ['Biological: Pneumococcal conjugate vaccine GSK2830930A', 'Biological: Infanrix hexa™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Synflorix Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).', 'interventionNames': ['Biological: Synflorix™', 'Biological: Infanrix hexa™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevnar13 Group', 'description': 'Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).', 'interventionNames': ['Biological: Prevnar 13™', 'Biological: Infanrix hexa™']}], 'interventions': [{'name': 'Pneumococcal conjugate vaccine GSK2830929A', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['11Pn Group']}, {'name': 'Pneumococcal conjugate vaccine GSK2830930A', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['12Pn Group']}, {'name': 'Synflorix™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['Synflorix Group']}, {'name': 'Prevnar 13™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['Prevnar13 Group']}, {'name': 'Infanrix hexa™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['11Pn Group', '12Pn Group', 'Prevnar13 Group', 'Synflorix Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '256 01', 'city': 'Benešov', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.78162, 'lon': 14.68697}}, {'zip': '405 01', 'city': 'Děčín', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.78215, 'lon': 14.21478}}, {'zip': '34401', 'city': 'Domažlice', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.44049, 'lon': 12.92976}}, {'zip': '37701', 'city': 'Jindřichův Hradec', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.14404, 'lon': 15.00301}}, {'zip': '272 01', 'city': 'Kladno', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}, {'zip': '46015', 'city': 'Liberec', 'country': 'Czechia', 'facility': 'GSK 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'29200', 'city': 'Antequera/Málaga', 'country': 'Spain', 'facility': 'GSK Investigational Site'}, {'zip': '09006', 'city': 'Burgos', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47012', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints of the study', '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'}}}}