Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT01204658
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2010-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib 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 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).', 'description': 'Solicited symptoms results are presented only for subjects for whom results were available.', 'eventGroups': [{'id': 'EG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.', 'otherNumAtRisk': 146, 'deathsNumAtRisk': 146, 'otherNumAffected': 141, 'seriousNumAtRisk': 146, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 137, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 139, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 134, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Pain', 'notes': 'Symptom reported during the 7-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Redness', 'notes': 'Symptom reported during the 7-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 88}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Swelling', 'notes': 'Symptom reported during the 7-day post-primary vaccination periods , across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drowsiness', 'notes': 'Symptom reported during the 7-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 98}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Irritability', 'notes': 'Symptom reported during the 7-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 113}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 110}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 113}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Loss of appetite', 'notes': 'Symptom reported during the 7-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fever (rectal temperature >= 38°C)', 'notes': 'Symptom reported during the 7-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 74}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'notes': 'Symptom reported during the 7-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Redness', 'notes': 'Symptom reported during the 7-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Swelling', 'notes': 'Symptom reported during the 7-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drowsiness', 'notes': 'Symptom reported during the 7-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 73}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Irritability', 'notes': 'Symptom reported during the 7-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 82}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 90}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Loss of appetite', 'notes': 'Symptom reported during the 7-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fever (rectal temperature >= 38°C)', 'notes': 'Symptom reported during the 7-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'notes': 'Unsolicited AE reported during the 31-day post-booster vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral infection', 'notes': 'Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Psychomotor retardation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Accidental exposure to product by child', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Breath holding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis Escherichia coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotonic-hyporesponsive episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rectal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Any Drowsiness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'G3 Drowsiness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Related Drowsiness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}, {'title': 'G3 Irritability, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Related Irritability, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss Appet., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'G3 Loss Appet., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Loss Appet., post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'G3 Fever, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', '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': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Related G3 Fever, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Drowsiness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}]}, {'title': 'G3 Drowsiness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Related Drowsiness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}]}, {'title': 'G3 Irritability, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Related Irritability, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss Appet., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'G3 Loss Appet., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Loss Appet., post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'G3 Fever, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', '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': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}, {'title': 'Related G3 Fever, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Drowsiness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Drowsiness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Related Drowsiness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'G3 Irritability, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Related Irritability, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss Appet., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'G3 Loss Appet., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Related Loss Appet., post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'G3 Fever, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', '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': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Related G3 Fever, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course', 'description': 'Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to \\[\\>=\\] 38 degrees Celsius \\[°C\\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (\\>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).', '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 against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Fever>40.0°C & Related Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever>40.0°C & Related Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever>40.0°C & Related Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever>40.0°C & Related across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '2.57', 'pValueComment': "1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \\> 40.0°C and causal relationship to vaccination \\> the boundary expressed as 5% + 0.5\\*rate in the Synflorix group.", 'groupDescription': 'Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-LD Group minus Synflorix Group.', 'statisticalMethod': "Kem Phillip's statistical test", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \\< 5%.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '2.57', 'pValueComment': "1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \\> 40.0°C and causal relationship to vaccination \\> the boundary expressed as 5% + 0.5\\*rate in the Synflorix group.", 'groupDescription': 'Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-LD Group minus Synflorix Group.', 'statisticalMethod': "Kem Phillip's statistical test", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \\< 5%.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.62', 'ciUpperLimit': '2.57', 'pValueComment': "1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \\> 40.0°C and causal relationship to vaccination \\> the boundary expressed as 5% + 0.5\\*rate in the Synflorix group.", 'groupDescription': 'Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-LD Group minus Synflorix Group.', 'statisticalMethod': "Kem Phillip's statistical test", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \\< 5%.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '2.57', 'pValueComment': "1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \\> 40.0°C and causal relationship to vaccination \\> the boundary expressed as 5% + 0.5\\*rate in the Synflorix group.", 'groupDescription': 'Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-LD Group minus Synflorix Group.', 'statisticalMethod': "Kem Phillip's statistical test", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \\< 5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses', 'description': 'Grade 3 fever was defined as fever by rectal measurement \\> 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.', 'unitOfMeasure': 'Percentage of 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 against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Fever>40.0°C & Related Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever>40.0°C & Related Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever>40.0°C & Related Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever>40.0°C & Related across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '2.64', 'pValueComment': "1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \\> 40.0°C and causal relationship to vaccination \\> the boundary expressed as 5% + 0.5\\*rate in the Synflorix group.", 'groupDescription': 'Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-HD Group minus Synflorix Group.', 'statisticalMethod': "Kem Phillip's statistical test", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \\< 5%.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '2.64', 'pValueComment': "1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \\> 40.0°C and causal relationship to vaccination \\> the boundary expressed as 5% + 0.5\\*rate in the Synflorix group.", 'groupDescription': 'Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-HD Group minus Synflorix Group.', 'statisticalMethod': "Kem Phillip's statistical test", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \\< 5%.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.63', 'ciUpperLimit': '2.66', 'pValueComment': "1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \\> 40.0°C and causal relationship to vaccination \\> the boundary expressed as 5% + 0.5\\*rate in the Synflorix group.", 'groupDescription': 'Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-HD Group minus Synflorix Group.', 'statisticalMethod': "Kem Phillip's statistical test", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \\< 5%.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '2.64', 'pValueComment': "1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \\> 40.0°C and causal relationship to vaccination \\> the boundary expressed as 5% + 0.5\\*rate in the Synflorix group.", 'groupDescription': 'Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-HD Group minus Synflorix Group.', 'statisticalMethod': "Kem Phillip's statistical test", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \\< 5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses', 'description': 'Grade 3 fever was defined as fever by rectal measurement \\>40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.', 'unitOfMeasure': 'Percentage of 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 against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Anti-dPly - At Month 3', 'categories': [{'measurements': [{'value': '9408.42', 'groupId': 'OG000', 'lowerLimit': '8182.15', 'upperLimit': '10818.47'}, {'value': '12137.96', 'groupId': 'OG001', 'lowerLimit': '10641.83', 'upperLimit': '13844.44'}, {'value': '459.97', 'groupId': 'OG002', 'lowerLimit': '398.31', 'upperLimit': '531.18'}, {'value': '472.88', 'groupId': 'OG003', 'lowerLimit': '404.48', 'upperLimit': '552.86'}]}]}, {'title': 'Anti-PhtD - At Month 3', 'categories': [{'measurements': [{'value': '1456.57', 'groupId': 'OG000', 'lowerLimit': '1250.65', 'upperLimit': '1696.39'}, {'value': '1996.61', 'groupId': 'OG001', 'lowerLimit': '1734.17', 'upperLimit': '2298.75'}, {'value': '523.61', 'groupId': 'OG002', 'lowerLimit': '453.71', 'upperLimit': '604.28'}, {'value': '552.01', 'groupId': 'OG003', 'lowerLimit': '469.55', 'upperLimit': '648.95'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Anti-dPly - Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6674.42', 'groupId': 'OG000', 'lowerLimit': '5628.57', 'upperLimit': '7914.60'}, {'value': '5592.85', 'groupId': 'OG001', 'lowerLimit': '4750.83', 'upperLimit': '6584.10'}, {'value': '495.02', 'groupId': 'OG002', 'lowerLimit': '393.19', 'upperLimit': '623.22'}, {'value': '737.71', 'groupId': 'OG003', 'lowerLimit': '587.67', 'upperLimit': '926.06'}]}]}, {'title': 'Anti-dPly - Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24720.40', 'groupId': 'OG000', 'lowerLimit': '21863.04', 'upperLimit': '27951.19'}, {'value': '29838.18', 'groupId': 'OG001', 'lowerLimit': '26892.53', 'upperLimit': '33106.48'}, {'value': '582.85', 'groupId': 'OG002', 'lowerLimit': '463.40', 'upperLimit': '733.09'}, {'value': '791.42', 'groupId': 'OG003', 'lowerLimit': '628.23', 'upperLimit': '997.00'}]}]}, {'title': 'Anti-PhtD - Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '910.80', 'groupId': 'OG000', 'lowerLimit': '718.85', 'upperLimit': '1154.00'}, {'value': '829.12', 'groupId': 'OG001', 'lowerLimit': '671.12', 'upperLimit': '1024.32'}, {'value': '209.27', 'groupId': 'OG002', 'lowerLimit': '153.16', 'upperLimit': '285.95'}, {'value': '381.66', 'groupId': 'OG003', 'lowerLimit': '274.64', 'upperLimit': '530.39'}]}]}, {'title': 'Anti-PhtD - Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3528.25', 'groupId': 'OG000', 'lowerLimit': '2952.68', 'upperLimit': '4216.01'}, {'value': '3777.39', 'groupId': 'OG001', 'lowerLimit': '3181.74', 'upperLimit': '4484.55'}, {'value': '266.58', 'groupId': 'OG002', 'lowerLimit': '190.06', 'upperLimit': '373.91'}, {'value': '469.16', 'groupId': 'OG003', 'lowerLimit': '335.29', 'upperLimit': '656.46'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'categories': [{'measurements': [{'value': '1135.7', 'groupId': 'OG000', 'lowerLimit': '927.8', 'upperLimit': '1390.1'}, {'value': '1323.3', 'groupId': 'OG001', 'lowerLimit': '1099.7', 'upperLimit': '1592.4'}, {'value': '1539.0', 'groupId': 'OG002', 'lowerLimit': '1258.4', 'upperLimit': '1882.1'}, {'value': '147.0', 'groupId': 'OG003', 'lowerLimit': '112.3', 'upperLimit': '192.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': '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 seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Anti-PD - Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '434.3', 'groupId': 'OG000', 'lowerLimit': '365.5', 'upperLimit': '516.0'}, {'value': '472.8', 'groupId': 'OG001', 'lowerLimit': '403.1', 'upperLimit': '554.5'}, {'value': '698.2', 'groupId': 'OG002', 'lowerLimit': '593.7', 'upperLimit': '821.0'}, {'value': '81.0', 'groupId': 'OG003', 'lowerLimit': '69.8', 'upperLimit': '93.9'}]}]}, {'title': 'Anti-PD - Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1655.4', 'groupId': 'OG000', 'lowerLimit': '1398.2', 'upperLimit': '1960.0'}, {'value': '1631.0', 'groupId': 'OG001', 'lowerLimit': '1404.5', 'upperLimit': '1894.2'}, {'value': '2394.2', 'groupId': 'OG002', 'lowerLimit': '2045.7', 'upperLimit': '2802.1'}, {'value': '85.7', 'groupId': 'OG003', 'lowerLimit': '73.6', 'upperLimit': '99.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': '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 seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-1 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.57', 'groupId': 'OG000', 'lowerLimit': '1.36', 'upperLimit': '1.80'}, {'value': '1.58', 'groupId': 'OG001', 'lowerLimit': '1.36', 'upperLimit': '1.83'}, {'value': '1.49', 'groupId': 'OG002', 'lowerLimit': '1.28', 'upperLimit': '1.74'}, {'value': '2.20', 'groupId': 'OG003', 'lowerLimit': '1.86', 'upperLimit': '2.60'}]}]}, {'title': 'ANTI-4 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000', 'lowerLimit': '1.74', 'upperLimit': '2.39'}, {'value': '2.11', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '2.43'}, {'value': '1.82', 'groupId': 'OG002', 'lowerLimit': '1.55', 'upperLimit': '2.14'}, {'value': '2.43', 'groupId': 'OG003', 'lowerLimit': '2.05', 'upperLimit': '2.88'}]}]}, {'title': 'ANTI-5 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000', 'lowerLimit': '2.13', 'upperLimit': '2.85'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '2.22', 'upperLimit': '2.92'}, {'value': '2.31', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '2.67'}, {'value': '2.77', 'groupId': 'OG003', 'lowerLimit': '2.27', 'upperLimit': '3.38'}]}]}, {'title': 'ANTI-6B At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.46'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.31', 'upperLimit': '0.45'}, {'value': '0.40', 'groupId': 'OG002', 'lowerLimit': '0.32', 'upperLimit': '0.51'}, {'value': '0.46', 'groupId': 'OG003', 'lowerLimit': '0.37', 'upperLimit': '0.57'}]}]}, {'title': 'ANTI-7F At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.12', 'groupId': 'OG000', 'lowerLimit': '1.86', 'upperLimit': '2.41'}, {'value': '2.21', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '2.48'}, {'value': '2.20', 'groupId': 'OG002', 'lowerLimit': '1.92', 'upperLimit': '2.50'}, {'value': '2.94', 'groupId': 'OG003', 'lowerLimit': '2.51', 'upperLimit': '3.46'}]}]}, {'title': 'ANTI-9V At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.83', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '2.12'}, {'value': '1.95', 'groupId': 'OG001', 'lowerLimit': '1.73', 'upperLimit': '2.20'}, {'value': '1.99', 'groupId': 'OG002', 'lowerLimit': '1.72', 'upperLimit': '2.30'}, {'value': '2.33', 'groupId': 'OG003', 'lowerLimit': '1.96', 'upperLimit': '2.76'}]}]}, {'title': 'ANTI-14 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.57', 'groupId': 'OG000', 'lowerLimit': '3.08', 'upperLimit': '4.14'}, {'value': '3.72', 'groupId': 'OG001', 'lowerLimit': '3.30', 'upperLimit': '4.18'}, {'value': '3.91', 'groupId': 'OG002', 'lowerLimit': '3.41', 'upperLimit': '4.48'}, {'value': '4.18', 'groupId': 'OG003', 'lowerLimit': '3.41', 'upperLimit': '5.13'}]}]}, {'title': 'ANTI-18C At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '2.67'}, {'value': '2.18', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '2.59'}, {'value': '2.45', 'groupId': 'OG002', 'lowerLimit': '2.04', 'upperLimit': '2.95'}, {'value': '2.56', 'groupId': 'OG003', 'lowerLimit': '2.14', 'upperLimit': '3.07'}]}]}, {'title': 'ANTI-19F At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.29', 'groupId': 'OG000', 'lowerLimit': '3.63', 'upperLimit': '5.07'}, {'value': '4.13', 'groupId': 'OG001', 'lowerLimit': '3.52', 'upperLimit': '4.85'}, {'value': '4.51', 'groupId': 'OG002', 'lowerLimit': '3.79', 'upperLimit': '5.36'}, {'value': '3.50', 'groupId': 'OG003', 'lowerLimit': '2.94', 'upperLimit': '4.18'}]}]}, {'title': 'ANTI-23F At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.82'}, {'value': '0.62', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.78'}, {'value': '0.67', 'groupId': 'OG002', 'lowerLimit': '0.54', 'upperLimit': '0.82'}, {'value': '1.48', 'groupId': 'OG003', 'lowerLimit': '1.17', 'upperLimit': '1.88'}]}]}, {'title': 'ANTI-3 (At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.04', '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': '2.47', 'groupId': 'OG003', 'lowerLimit': '2.08', 'upperLimit': '2.93'}]}]}, {'title': 'ANTI-6A At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.16'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.14'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '0.09', 'upperLimit': '0.14'}, {'value': '2.05', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '2.50'}]}]}, {'title': 'ANTI-19A At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.23'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.21'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.13', 'upperLimit': '0.20'}, {'value': '2.77', 'groupId': 'OG003', 'lowerLimit': '2.34', 'upperLimit': '3.28'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', '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 enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-1 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.35'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.36'}, {'value': '0.26', 'groupId': 'OG002', 'lowerLimit': '0.22', 'upperLimit': '0.31'}, {'value': '0.49', 'groupId': 'OG003', 'lowerLimit': '0.43', 'upperLimit': '0.55'}]}]}, {'title': 'ANTI-1 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.62', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '3.04'}, {'value': '2.61', 'groupId': 'OG001', 'lowerLimit': '2.27', 'upperLimit': '3.00'}, {'value': '2.41', 'groupId': 'OG002', 'lowerLimit': '2.06', 'upperLimit': '2.82'}, {'value': '3.78', 'groupId': 'OG003', 'lowerLimit': '3.34', 'upperLimit': '4.28'}]}]}, {'title': 'ANTI-4 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.58'}, {'value': '0.51', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '0.61'}, {'value': '0.58', 'groupId': 'OG002', 'lowerLimit': '0.49', 'upperLimit': '0.70'}, {'value': '0.40', 'groupId': 'OG003', 'lowerLimit': '0.35', 'upperLimit': '0.46'}]}]}, {'title': 'ANTI-4 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.10', 'groupId': 'OG000', 'lowerLimit': '3.54', 'upperLimit': '4.74'}, {'value': '3.90', 'groupId': 'OG001', 'lowerLimit': '3.35', 'upperLimit': '4.53'}, {'value': '3.98', 'groupId': 'OG002', 'lowerLimit': '3.51', 'upperLimit': '4.52'}, {'value': '4.36', 'groupId': 'OG003', 'lowerLimit': '3.77', 'upperLimit': '5.05'}]}]}, {'title': 'ANTI-5 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.69'}, {'value': '0.58', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '0.68'}, {'value': '0.55', 'groupId': 'OG002', 'lowerLimit': '0.47', 'upperLimit': '0.65'}, {'value': '0.85', 'groupId': 'OG003', 'lowerLimit': '0.74', 'upperLimit': '0.99'}]}]}, {'title': 'ANTI-5 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.48', 'groupId': 'OG000', 'lowerLimit': '2.98', 'upperLimit': '4.05'}, {'value': '3.44', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '3.96'}, {'value': '3.33', 'groupId': 'OG002', 'lowerLimit': '2.87', 'upperLimit': '3.87'}, {'value': '7.52', 'groupId': 'OG003', 'lowerLimit': '6.52', 'upperLimit': '8.68'}]}]}, {'title': 'ANTI-6B Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.53'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.56'}, {'value': '0.46', 'groupId': 'OG002', 'lowerLimit': '0.38', 'upperLimit': '0.55'}, {'value': '0.25', 'groupId': 'OG003', 'lowerLimit': '0.21', 'upperLimit': '0.31'}]}]}, {'title': 'ANTI-6B Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000', 'lowerLimit': '1.77', 'upperLimit': '2.36'}, {'value': '1.96', 'groupId': 'OG001', 'lowerLimit': '1.67', 'upperLimit': '2.30'}, {'value': '2.28', 'groupId': 'OG002', 'lowerLimit': '1.94', 'upperLimit': '2.68'}, {'value': '3.11', 'groupId': 'OG003', 'lowerLimit': '2.65', 'upperLimit': '3.64'}]}]}, {'title': 'ANTI-7F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '1.09'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '1.15'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.85', 'upperLimit': '1.13'}, {'value': '1.34', 'groupId': 'OG003', 'lowerLimit': '1.18', 'upperLimit': '1.53'}]}]}, {'title': 'ANTI-7F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.72', 'groupId': 'OG000', 'lowerLimit': '4.13', 'upperLimit': '5.40'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '4.19', 'upperLimit': '5.27'}, {'value': '4.87', 'groupId': 'OG002', 'lowerLimit': '4.32', 'upperLimit': '5.50'}, {'value': '7.68', 'groupId': 'OG003', 'lowerLimit': '6.84', 'upperLimit': '8.61'}]}]}, {'title': 'ANTI-9V Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '0.90'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.84', 'upperLimit': '1.12'}, {'value': '0.99', 'groupId': 'OG002', 'lowerLimit': '0.85', 'upperLimit': '1.16'}, {'value': '0.58', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '0.68'}]}]}, {'title': 'ANTI-9V Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.48', 'groupId': 'OG000', 'lowerLimit': '3.90', 'upperLimit': '5.14'}, {'value': '4.91', 'groupId': 'OG001', 'lowerLimit': '4.32', 'upperLimit': '5.58'}, {'value': '5.20', 'groupId': 'OG002', 'lowerLimit': '4.52', 'upperLimit': '5.97'}, {'value': '6.57', 'groupId': 'OG003', 'lowerLimit': '5.67', 'upperLimit': '7.60'}]}]}, {'title': 'ANTI-14 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '1.65'}, {'value': '1.43', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '1.73'}, {'value': '1.57', 'groupId': 'OG002', 'lowerLimit': '1.28', 'upperLimit': '1.93'}, {'value': '2.06', 'groupId': 'OG003', 'lowerLimit': '1.72', 'upperLimit': '2.47'}]}]}, {'title': 'ANTI-14 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.06', 'groupId': 'OG000', 'lowerLimit': '5.18', 'upperLimit': '7.09'}, {'value': '7.18', 'groupId': 'OG001', 'lowerLimit': '6.14', 'upperLimit': '8.39'}, {'value': '6.63', 'groupId': 'OG002', 'lowerLimit': '5.59', 'upperLimit': '7.86'}, {'value': '11.43', 'groupId': 'OG003', 'lowerLimit': '9.81', 'upperLimit': '13.30'}]}]}, {'title': 'ANTI-18C Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.87'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '0.89'}, {'value': '0.92', 'groupId': 'OG002', 'lowerLimit': '0.77', 'upperLimit': '1.10'}, {'value': '0.75', 'groupId': 'OG003', 'lowerLimit': '0.65', 'upperLimit': '0.85'}]}]}, {'title': 'ANTI-18C Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.68', 'groupId': 'OG000', 'lowerLimit': '5.76', 'upperLimit': '7.75'}, {'value': '6.38', 'groupId': 'OG001', 'lowerLimit': '5.48', 'upperLimit': '7.42'}, {'value': '7.65', 'groupId': 'OG002', 'lowerLimit': '6.76', 'upperLimit': '8.67'}, {'value': '6.40', 'groupId': 'OG003', 'lowerLimit': '5.50', 'upperLimit': '7.45'}]}]}, {'title': 'ANTI-19F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '1.47'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '1.33'}, {'value': '1.30', 'groupId': 'OG002', 'lowerLimit': '1.06', 'upperLimit': '1.58'}, {'value': '0.66', 'groupId': 'OG003', 'lowerLimit': '0.53', 'upperLimit': '0.82'}]}]}, {'title': 'ANTI-19F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.73', 'groupId': 'OG000', 'lowerLimit': '5.77', 'upperLimit': '7.83'}, {'value': '7.22', 'groupId': 'OG001', 'lowerLimit': '6.25', 'upperLimit': '8.33'}, {'value': '7.84', 'groupId': 'OG002', 'lowerLimit': '6.78', 'upperLimit': '9.06'}, {'value': '7.43', 'groupId': 'OG003', 'lowerLimit': '6.35', 'upperLimit': '8.69'}]}]}, {'title': 'ANTI-23F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.56'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '0.58'}, {'value': '0.57', 'groupId': 'OG002', 'lowerLimit': '0.48', 'upperLimit': '0.68'}, {'value': '0.37', 'groupId': 'OG003', 'lowerLimit': '0.30', 'upperLimit': '0.44'}]}]}, {'title': 'ANTI-23F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.20', 'groupId': 'OG000', 'lowerLimit': '2.68', 'upperLimit': '3.83'}, {'value': '3.20', 'groupId': 'OG001', 'lowerLimit': '2.70', 'upperLimit': '3.78'}, {'value': '3.72', 'groupId': 'OG002', 'lowerLimit': '3.21', 'upperLimit': '4.31'}, {'value': '7.10', 'groupId': 'OG003', 'lowerLimit': '6.05', 'upperLimit': '8.35'}]}]}, {'title': 'ANTI-3 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.32', 'groupId': 'OG003', 'lowerLimit': '0.27', 'upperLimit': '0.38'}]}]}, {'title': 'ANTI-3 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.07'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.07'}, {'value': '1.83', 'groupId': 'OG003', 'lowerLimit': '1.58', 'upperLimit': '2.12'}]}]}, {'title': 'ANTI-6A Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.24'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.22'}, {'value': '0.20', 'groupId': 'OG002', 'lowerLimit': '0.16', 'upperLimit': '0.24'}, {'value': '0.70', 'groupId': 'OG003', 'lowerLimit': '0.59', 'upperLimit': '0.83'}]}]}, {'title': 'ANTI-6A Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '1.11'}, {'value': '0.74', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '0.93'}, {'value': '0.99', 'groupId': 'OG002', 'lowerLimit': '0.78', 'upperLimit': '1.26'}, {'value': '7.77', 'groupId': 'OG003', 'lowerLimit': '6.60', 'upperLimit': '9.14'}]}]}, {'title': 'ANTI-19A Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.22'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.18'}, {'value': '0.18', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.22'}, {'value': '0.57', 'groupId': 'OG003', 'lowerLimit': '0.44', 'upperLimit': '0.73'}]}]}, {'title': 'ANTI-19A Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.41'}, {'value': '1.03', 'groupId': 'OG001', 'lowerLimit': '0.80', 'upperLimit': '1.31'}, {'value': '1.23', 'groupId': 'OG002', 'lowerLimit': '0.99', 'upperLimit': '1.52'}, {'value': '7.77', 'groupId': 'OG003', 'lowerLimit': '6.43', 'upperLimit': '9.39'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', '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 enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'OPA-1 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000', 'lowerLimit': '24.6', 'upperLimit': '60.5'}, {'value': '27.8', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '44.2'}, {'value': '29.4', 'groupId': 'OG002', 'lowerLimit': '19.4', 'upperLimit': '44.5'}, {'value': '68.9', 'groupId': 'OG003', 'lowerLimit': '47.5', 'upperLimit': '99.9'}]}]}, {'title': 'OPA-4 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '703.7', 'groupId': 'OG000', 'lowerLimit': '533.5', 'upperLimit': '928.2'}, {'value': '844.4', 'groupId': 'OG001', 'lowerLimit': '660.8', 'upperLimit': '1079.0'}, {'value': '819.2', 'groupId': 'OG002', 'lowerLimit': '652.7', 'upperLimit': '1028.1'}, {'value': '748.1', 'groupId': 'OG003', 'lowerLimit': '509.9', 'upperLimit': '1097.5'}]}]}, {'title': 'OPA-5 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '33.6', 'upperLimit': '66.6'}, {'value': '60.6', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '83.3'}, {'value': '50.3', 'groupId': 'OG002', 'lowerLimit': '37.2', 'upperLimit': '68.1'}, {'value': '72.9', 'groupId': 'OG003', 'lowerLimit': '52.2', 'upperLimit': '101.8'}]}]}, {'title': 'OPA-6B At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '399.6', 'groupId': 'OG000', 'lowerLimit': '249.4', 'upperLimit': '640.4'}, {'value': '454.7', 'groupId': 'OG001', 'lowerLimit': '299.8', 'upperLimit': '689.7'}, {'value': '409.7', 'groupId': 'OG002', 'lowerLimit': '251.0', 'upperLimit': '668.7'}, {'value': '884.9', 'groupId': 'OG003', 'lowerLimit': '569.3', 'upperLimit': '1375.5'}]}]}, {'title': 'OPA-7F At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3212.6', 'groupId': 'OG000', 'lowerLimit': '2434.8', 'upperLimit': '4238.8'}, {'value': '3697.6', 'groupId': 'OG001', 'lowerLimit': '2748.6', 'upperLimit': '4974.1'}, {'value': '4234.2', 'groupId': 'OG002', 'lowerLimit': '3203.0', 'upperLimit': '5597.4'}, {'value': '7394.5', 'groupId': 'OG003', 'lowerLimit': '4411.1', 'upperLimit': '12395.7'}]}]}, {'title': 'OPA-9V At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1942.4', 'groupId': 'OG000', 'lowerLimit': '1381.9', 'upperLimit': '2730.1'}, {'value': '1520.7', 'groupId': 'OG001', 'lowerLimit': '1109.4', 'upperLimit': '2084.5'}, {'value': '1983.6', 'groupId': 'OG002', 'lowerLimit': '1507.2', 'upperLimit': '2610.7'}, {'value': '2242.8', 'groupId': 'OG003', 'lowerLimit': '1474.7', 'upperLimit': '3411.1'}]}]}, {'title': 'OPA-14 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1405.3', 'groupId': 'OG000', 'lowerLimit': '1060.3', 'upperLimit': '1862.4'}, {'value': '1334.9', 'groupId': 'OG001', 'lowerLimit': '1013.9', 'upperLimit': '1757.4'}, {'value': '1575.3', 'groupId': 'OG002', 'lowerLimit': '1143.5', 'upperLimit': '2170.1'}, {'value': '2410.6', 'groupId': 'OG003', 'lowerLimit': '1516.6', 'upperLimit': '3831.5'}]}]}, {'title': 'OPA-18C At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '108.1', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '161.2'}, {'value': '102.7', 'groupId': 'OG001', 'lowerLimit': '70.3', 'upperLimit': '150.0'}, {'value': '169.4', 'groupId': 'OG002', 'lowerLimit': '121.9', 'upperLimit': '235.4'}, {'value': '257.6', 'groupId': 'OG003', 'lowerLimit': '179.4', 'upperLimit': '369.9'}]}]}, {'title': 'OPA-19F At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '211.6', 'groupId': 'OG000', 'lowerLimit': '139.6', 'upperLimit': '320.7'}, {'value': '344.1', 'groupId': 'OG001', 'lowerLimit': '240.6', 'upperLimit': '492.0'}, {'value': '381.6', 'groupId': 'OG002', 'lowerLimit': '256.8', 'upperLimit': '566.9'}, {'value': '142.5', 'groupId': 'OG003', 'lowerLimit': '98.9', 'upperLimit': '205.4'}]}]}, {'title': 'OPA-23F At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1275.6', 'groupId': 'OG000', 'lowerLimit': '771.1', 'upperLimit': '2110.3'}, {'value': '2170.3', 'groupId': 'OG001', 'lowerLimit': '1559.9', 'upperLimit': '3019.6'}, {'value': '1757.9', 'groupId': 'OG002', 'lowerLimit': '1191.4', 'upperLimit': '2593.7'}, {'value': '4437.1', 'groupId': 'OG003', 'lowerLimit': '2874.9', 'upperLimit': '6848.2'}]}]}, {'title': 'OPA-3 (At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '6.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.2'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '5.3'}, {'value': '88.4', 'groupId': 'OG003', 'lowerLimit': '67.3', 'upperLimit': '116.0'}]}]}, {'title': 'OPA-6A At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '78.5'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '35.4', 'upperLimit': '100.3'}, {'value': '44.7', 'groupId': 'OG002', 'lowerLimit': '26.2', 'upperLimit': '76.2'}, {'value': '1726.0', 'groupId': 'OG003', 'lowerLimit': '1113.9', 'upperLimit': '2674.4'}]}]}, {'title': 'OPA-19A At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '576.0', 'groupId': 'OG000', 'lowerLimit': '340.6', 'upperLimit': '974.3'}, {'value': '914.6', 'groupId': 'OG001', 'lowerLimit': '586.8', 'upperLimit': '1425.6'}, {'value': '905.2', 'groupId': 'OG002', 'lowerLimit': '628.2', 'upperLimit': '1304.5'}, {'value': '2915.3', 'groupId': 'OG003', 'lowerLimit': '2270.3', 'upperLimit': '3743.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', '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, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Primary Phase of the study.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'OPA-1 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '20.1'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '21.1'}, {'value': '18.7', 'groupId': 'OG002', 'lowerLimit': '11.2', 'upperLimit': '31.4'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '6.8', 'upperLimit': '15.5'}]}]}, {'title': 'OPA-1 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '373.5', 'groupId': 'OG000', 'lowerLimit': '253.3', 'upperLimit': '550.8'}, {'value': '369.2', 'groupId': 'OG001', 'lowerLimit': '252.8', 'upperLimit': '539.4'}, {'value': '300.0', 'groupId': 'OG002', 'lowerLimit': '213.2', 'upperLimit': '422.1'}, {'value': '369.3', 'groupId': 'OG003', 'lowerLimit': '281.4', 'upperLimit': '484.6'}]}]}, {'title': 'OPA-4 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '68.4'}, {'value': '48.3', 'groupId': 'OG001', 'lowerLimit': '25.6', 'upperLimit': '91.0'}, {'value': '122.3', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '199.6'}, {'value': '18.5', 'groupId': 'OG003', 'lowerLimit': '9.7', 'upperLimit': '35.4'}]}]}, {'title': 'OPA-4 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1370.7', 'groupId': 'OG000', 'lowerLimit': '1034.2', 'upperLimit': '1816.6'}, {'value': '1634.8', 'groupId': 'OG001', 'lowerLimit': '1284.8', 'upperLimit': '2080.3'}, {'value': '2043.3', 'groupId': 'OG002', 'lowerLimit': '1609.1', 'upperLimit': '2594.6'}, {'value': '2882.6', 'groupId': 'OG003', 'lowerLimit': '2252.4', 'upperLimit': '3689.1'}]}]}, {'title': 'OPA-5 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '12.5'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '16.1'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '6.9', 'upperLimit': '12.9'}, {'value': '8.7', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '12.0'}]}]}, {'title': 'OPA-5 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '154.5', 'groupId': 'OG000', 'lowerLimit': '111.8', 'upperLimit': '213.4'}, {'value': '166.8', 'groupId': 'OG001', 'lowerLimit': '118.4', 'upperLimit': '234.8'}, {'value': '139.3', 'groupId': 'OG002', 'lowerLimit': '102.3', 'upperLimit': '189.8'}, {'value': '327.4', 'groupId': 'OG003', 'lowerLimit': '254.2', 'upperLimit': '421.8'}]}]}, {'title': 'OPA-6B Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103.2', 'groupId': 'OG000', 'lowerLimit': '56.5', 'upperLimit': '188.4'}, {'value': '174.5', 'groupId': 'OG001', 'lowerLimit': '102.1', 'upperLimit': '298.2'}, {'value': '136.9', 'groupId': 'OG002', 'lowerLimit': '76.1', 'upperLimit': '246.4'}, {'value': '113.8', 'groupId': 'OG003', 'lowerLimit': '59.3', 'upperLimit': '218.6'}]}]}, {'title': 'OPA-6B Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '802.1', 'groupId': 'OG000', 'lowerLimit': '531.7', 'upperLimit': '1210.0'}, {'value': '700.3', 'groupId': 'OG001', 'lowerLimit': '481.3', 'upperLimit': '1018.8'}, {'value': '1013.8', 'groupId': 'OG002', 'lowerLimit': '744.6', 'upperLimit': '1380.3'}, {'value': '2731.1', 'groupId': 'OG003', 'lowerLimit': '1972.7', 'upperLimit': '3781.1'}]}]}, {'title': 'OPA-7F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '795.5', 'groupId': 'OG000', 'lowerLimit': '560.1', 'upperLimit': '1129.9'}, {'value': '886.4', 'groupId': 'OG001', 'lowerLimit': '599.1', 'upperLimit': '1311.5'}, {'value': '1322.5', 'groupId': 'OG002', 'lowerLimit': '961.5', 'upperLimit': '1819.1'}, {'value': '1895.8', 'groupId': 'OG003', 'lowerLimit': '1420.6', 'upperLimit': '2530.0'}]}]}, {'title': 'OPA-7F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5819.9', 'groupId': 'OG000', 'lowerLimit': '4473.1', 'upperLimit': '7572.2'}, {'value': '5733.8', 'groupId': 'OG001', 'lowerLimit': '4165.0', 'upperLimit': '7893.5'}, {'value': '8336.9', 'groupId': 'OG002', 'lowerLimit': '6357.9', 'upperLimit': '10931.8'}, {'value': '18012.3', 'groupId': 'OG003', 'lowerLimit': '13872.4', 'upperLimit': '23387.7'}]}]}, {'title': 'OPA-9V Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '281.5', 'groupId': 'OG000', 'lowerLimit': '175.4', 'upperLimit': '451.7'}, {'value': '340.8', 'groupId': 'OG001', 'lowerLimit': '224.0', 'upperLimit': '518.5'}, {'value': '433.7', 'groupId': 'OG002', 'lowerLimit': '318.3', 'upperLimit': '591.0'}, {'value': '510.4', 'groupId': 'OG003', 'lowerLimit': '344.6', 'upperLimit': '755.8'}]}]}, {'title': 'OPA-9V Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2001.6', 'groupId': 'OG000', 'lowerLimit': '1506.6', 'upperLimit': '2659.3'}, {'value': '2436.5', 'groupId': 'OG001', 'lowerLimit': '1734.5', 'upperLimit': '3422.6'}, {'value': '3711.7', 'groupId': 'OG002', 'lowerLimit': '2881.2', 'upperLimit': '4781.4'}, {'value': '6839.2', 'groupId': 'OG003', 'lowerLimit': '5464.7', 'upperLimit': '8559.3'}]}]}, {'title': 'OPA-14 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '275.8', 'groupId': 'OG000', 'lowerLimit': '175.2', 'upperLimit': '434.3'}, {'value': '208.1', 'groupId': 'OG001', 'lowerLimit': '111.9', 'upperLimit': '386.9'}, {'value': '355.6', 'groupId': 'OG002', 'lowerLimit': '216.3', 'upperLimit': '584.8'}, {'value': '483.0', 'groupId': 'OG003', 'lowerLimit': '286.9', 'upperLimit': '813.1'}]}]}, {'title': 'OPA-14 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2216.9', 'groupId': 'OG000', 'lowerLimit': '1678.0', 'upperLimit': '2928.9'}, {'value': '2297.4', 'groupId': 'OG001', 'lowerLimit': '1640.0', 'upperLimit': '3218.4'}, {'value': '2488.9', 'groupId': 'OG002', 'lowerLimit': '1942.5', 'upperLimit': '3189.0'}, {'value': '3545.0', 'groupId': 'OG003', 'lowerLimit': '2465.2', 'upperLimit': '5097.8'}]}]}, {'title': 'OPA-18C Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '6.6'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '8.7'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '9.0'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '3.9', 'upperLimit': '6.1'}]}]}, {'title': 'OPA-18C Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '374.6', 'groupId': 'OG000', 'lowerLimit': '271.2', 'upperLimit': '517.4'}, {'value': '303.6', 'groupId': 'OG001', 'lowerLimit': '197.7', 'upperLimit': '466.3'}, {'value': '511.0', 'groupId': 'OG002', 'lowerLimit': '356.7', 'upperLimit': '732.2'}, {'value': '464.4', 'groupId': 'OG003', 'lowerLimit': '327.7', 'upperLimit': '658.1'}]}]}, {'title': 'OPA-19F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '29.0'}, {'value': '31.0', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '49.9'}, {'value': '30.7', 'groupId': 'OG002', 'lowerLimit': '19.2', 'upperLimit': '49.2'}, {'value': '7.4', 'groupId': 'OG003', 'lowerLimit': '4.8', 'upperLimit': '11.5'}]}]}, {'title': 'OPA-19F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '650.2', 'groupId': 'OG000', 'lowerLimit': '444.1', 'upperLimit': '951.9'}, {'value': '778.9', 'groupId': 'OG001', 'lowerLimit': '500.4', 'upperLimit': '1212.3'}, {'value': '1053.9', 'groupId': 'OG002', 'lowerLimit': '812.6', 'upperLimit': '1366.8'}, {'value': '767.1', 'groupId': 'OG003', 'lowerLimit': '582.1', 'upperLimit': '1010.9'}]}]}, {'title': 'OPA-23F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '189.6', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '430.5'}, {'value': '281.4', 'groupId': 'OG001', 'lowerLimit': '123.2', 'upperLimit': '642.8'}, {'value': '242.5', 'groupId': 'OG002', 'lowerLimit': '106.5', 'upperLimit': '552.2'}, {'value': '367.4', 'groupId': 'OG003', 'lowerLimit': '150.3', 'upperLimit': '897.8'}]}]}, {'title': 'OPA-23F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3621.0', 'groupId': 'OG000', 'lowerLimit': '2534.5', 'upperLimit': '5173.2'}, {'value': '2563.6', 'groupId': 'OG001', 'lowerLimit': '1831.6', 'upperLimit': '3588.2'}, {'value': '4465.4', 'groupId': 'OG002', 'lowerLimit': '3368.6', 'upperLimit': '5919.3'}, {'value': '32508.0', 'groupId': 'OG003', 'lowerLimit': '23754.9', 'upperLimit': '44486.3'}]}]}, {'title': 'OPA-3 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '9.5'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '14.0'}, {'value': '6.3', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '8.8'}, {'value': '12.0', 'groupId': 'OG003', 'lowerLimit': '7.6', 'upperLimit': '19.1'}]}]}, {'title': 'OPA-3 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '10.6'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '11.2'}, {'value': '9.2', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '12.5'}, {'value': '333.9', 'groupId': 'OG003', 'lowerLimit': '260.3', 'upperLimit': '428.3'}]}]}, {'title': 'OPA-6A Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '52.9'}, {'value': '23.3', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '53.1'}, {'value': '18.7', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '35.7'}, {'value': '129.7', 'groupId': 'OG003', 'lowerLimit': '61.2', 'upperLimit': '274.7'}]}]}, {'title': 'OPA-6A Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '163.1', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '283.1'}, {'value': '190.0', 'groupId': 'OG001', 'lowerLimit': '106.6', 'upperLimit': '338.4'}, {'value': '276.2', 'groupId': 'OG002', 'lowerLimit': '174.8', 'upperLimit': '436.6'}, {'value': '4855.3', 'groupId': 'OG003', 'lowerLimit': '3606.3', 'upperLimit': '6536.8'}]}]}, {'title': 'OPA-19A Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '211.8', 'groupId': 'OG000', 'lowerLimit': '139.2', 'upperLimit': '322.4'}, {'value': '262.0', 'groupId': 'OG001', 'lowerLimit': '157.8', 'upperLimit': '435.1'}, {'value': '315.6', 'groupId': 'OG002', 'lowerLimit': '193.5', 'upperLimit': '514.6'}, {'value': '776.3', 'groupId': 'OG003', 'lowerLimit': '542.2', 'upperLimit': '1111.7'}]}]}, {'title': 'OPA-19A Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2006.3', 'groupId': 'OG000', 'lowerLimit': '1539.1', 'upperLimit': '2615.3'}, {'value': '2609.5', 'groupId': 'OG001', 'lowerLimit': '1919.1', 'upperLimit': '3548.2'}, {'value': '2699.1', 'groupId': 'OG002', 'lowerLimit': '2262.2', 'upperLimit': '3220.5'}, {'value': '7137.0', 'groupId': 'OG003', 'lowerLimit': '5909.4', 'upperLimit': '8619.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', '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, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Booster Phase of the study.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - 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': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis could not be performed as no validated assay was available.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - 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': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis could not be performed as no validated assay was available.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-D At Month 3', 'categories': [{'measurements': [{'value': '3.251', 'groupId': 'OG000', 'lowerLimit': '2.729', 'upperLimit': '3.873'}, {'value': '3.185', 'groupId': 'OG001', 'lowerLimit': '2.556', 'upperLimit': '3.968'}, {'value': '3.353', 'groupId': 'OG002', 'lowerLimit': '2.756', 'upperLimit': '4.080'}, {'value': '2.933', 'groupId': 'OG003', 'lowerLimit': '2.464', 'upperLimit': '3.492'}]}]}, {'title': 'ANTI-T At Month 3', 'categories': [{'measurements': [{'value': '2.579', 'groupId': 'OG000', 'lowerLimit': '2.187', 'upperLimit': '3.041'}, {'value': '2.193', 'groupId': 'OG001', 'lowerLimit': '1.819', 'upperLimit': '2.643'}, {'value': '2.252', 'groupId': 'OG002', 'lowerLimit': '1.930', 'upperLimit': '2.627'}, {'value': '1.416', 'groupId': 'OG003', 'lowerLimit': '1.166', 'upperLimit': '1.719'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-D At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.731', 'groupId': 'OG000', 'lowerLimit': '0.575', 'upperLimit': '0.929'}, {'value': '0.587', 'groupId': 'OG001', 'lowerLimit': '0.461', 'upperLimit': '0.747'}, {'value': '0.651', 'groupId': 'OG002', 'lowerLimit': '0.507', 'upperLimit': '0.836'}, {'value': '0.614', 'groupId': 'OG003', 'lowerLimit': '0.497', 'upperLimit': '0.758'}]}]}, {'title': 'ANTI-D At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.872', 'groupId': 'OG000', 'lowerLimit': '8.191', 'upperLimit': '11.898'}, {'value': '8.688', 'groupId': 'OG001', 'lowerLimit': '7.026', 'upperLimit': '10.743'}, {'value': '9.742', 'groupId': 'OG002', 'lowerLimit': '7.991', 'upperLimit': '11.878'}, {'value': '8.290', 'groupId': 'OG003', 'lowerLimit': '6.943', 'upperLimit': '9.899'}]}]}, {'title': 'ANTI-T At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.815', 'groupId': 'OG000', 'lowerLimit': '0.665', 'upperLimit': '0.999'}, {'value': '0.727', 'groupId': 'OG001', 'lowerLimit': '0.570', 'upperLimit': '0.927'}, {'value': '0.726', 'groupId': 'OG002', 'lowerLimit': '0.604', 'upperLimit': '0.874'}, {'value': '0.371', 'groupId': 'OG003', 'lowerLimit': '0.280', 'upperLimit': '0.493'}]}]}, {'title': 'ANTI-T At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.725', 'groupId': 'OG000', 'lowerLimit': '7.259', 'upperLimit': '10.488'}, {'value': '8.703', 'groupId': 'OG001', 'lowerLimit': '7.415', 'upperLimit': '10.215'}, {'value': '9.929', 'groupId': 'OG002', 'lowerLimit': '8.653', 'upperLimit': '11.394'}, {'value': '5.040', 'groupId': 'OG003', 'lowerLimit': '4.074', 'upperLimit': '6.234'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-PT At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '59.9', 'upperLimit': '79.4'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '54.8', 'upperLimit': '75.3'}, {'value': '70.0', 'groupId': 'OG002', 'lowerLimit': '61.6', 'upperLimit': '79.4'}, {'value': '64.6', 'groupId': 'OG003', 'lowerLimit': '53.2', 'upperLimit': '78.3'}]}]}, {'title': 'ANTI-FHA At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '187.9', 'groupId': 'OG000', 'lowerLimit': '159.0', 'upperLimit': '222.1'}, {'value': '178.1', 'groupId': 'OG001', 'lowerLimit': '150.2', 'upperLimit': '211.2'}, {'value': '157.1', 'groupId': 'OG002', 'lowerLimit': '132.5', 'upperLimit': '186.3'}, {'value': '188.6', 'groupId': 'OG003', 'lowerLimit': '156.4', 'upperLimit': '227.5'}]}]}, {'title': 'ANTI-PRN At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '114.4'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '63.6', 'upperLimit': '99.2'}, {'value': '91.4', 'groupId': 'OG002', 'lowerLimit': '75.2', 'upperLimit': '111.1'}, {'value': '87.2', 'groupId': 'OG003', 'lowerLimit': '70.6', 'upperLimit': '107.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-PT At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '22.9'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '16.3'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '9.7', 'upperLimit': '15.1'}, {'value': '12.2', 'groupId': 'OG003', 'lowerLimit': '9.6', 'upperLimit': '15.5'}]}]}, {'title': 'ANTI-PT At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '75.4', 'upperLimit': '116.6'}, {'value': '90.6', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '111.7'}, {'value': '95.7', 'groupId': 'OG002', 'lowerLimit': '80.1', 'upperLimit': '114.3'}, {'value': '85.2', 'groupId': 'OG003', 'lowerLimit': '70.3', 'upperLimit': '103.2'}]}]}, {'title': 'ANTI-FHA At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '50.3', 'upperLimit': '78.9'}, {'value': '51.7', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '66.6'}, {'value': '48.5', 'groupId': 'OG002', 'lowerLimit': '38.3', 'upperLimit': '61.5'}, {'value': '54.2', 'groupId': 'OG003', 'lowerLimit': '42.5', 'upperLimit': '69.2'}]}]}, {'title': 'ANTI-FHA At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '359.4', 'groupId': 'OG000', 'lowerLimit': '291.3', 'upperLimit': '443.5'}, {'value': '380.1', 'groupId': 'OG001', 'lowerLimit': '311.9', 'upperLimit': '463.2'}, {'value': '308.4', 'groupId': 'OG002', 'lowerLimit': '252.0', 'upperLimit': '377.3'}, {'value': '376.7', 'groupId': 'OG003', 'lowerLimit': '322.6', 'upperLimit': '439.8'}]}]}, {'title': 'ANTI-PRN At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '30.1'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '22.2'}, {'value': '14.3', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '19.3'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '10.6', 'upperLimit': '19.3'}]}]}, {'title': 'ANTI-PRN At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '294.8', 'groupId': 'OG000', 'lowerLimit': '227.0', 'upperLimit': '382.8'}, {'value': '228.5', 'groupId': 'OG001', 'lowerLimit': '174.2', 'upperLimit': '299.7'}, {'value': '224.2', 'groupId': 'OG002', 'lowerLimit': '180.0', 'upperLimit': '279.1'}, {'value': '197.3', 'groupId': 'OG003', 'lowerLimit': '154.3', 'upperLimit': '252.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'categories': [{'measurements': [{'value': '676.7', 'groupId': 'OG000', 'lowerLimit': '466.2', 'upperLimit': '982.3'}, {'value': '619.1', 'groupId': 'OG001', 'lowerLimit': '386.5', 'upperLimit': '991.5'}, {'value': '719.8', 'groupId': 'OG002', 'lowerLimit': '537.0', 'upperLimit': '965.0'}, {'value': '877.4', 'groupId': 'OG003', 'lowerLimit': '597.0', 'upperLimit': '1289.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-HBs At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '299.2', 'groupId': 'OG000', 'lowerLimit': '199.0', 'upperLimit': '449.8'}, {'value': '287.1', 'groupId': 'OG001', 'lowerLimit': '195.1', 'upperLimit': '422.4'}, {'value': '166.6', 'groupId': 'OG002', 'lowerLimit': '105.2', 'upperLimit': '263.8'}, {'value': '174.5', 'groupId': 'OG003', 'lowerLimit': '113.5', 'upperLimit': '268.2'}]}]}, {'title': 'ANTI-HBs At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4110.9', 'groupId': 'OG000', 'lowerLimit': '2576.5', 'upperLimit': '6558.9'}, {'value': '4234.8', 'groupId': 'OG001', 'lowerLimit': '2961.4', 'upperLimit': '6055.7'}, {'value': '3142.4', 'groupId': 'OG002', 'lowerLimit': '2151.1', 'upperLimit': '4590.6'}, {'value': '3116.4', 'groupId': 'OG003', 'lowerLimit': '2142.5', 'upperLimit': '4533.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study. \\* A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.920', 'groupId': 'OG000', 'lowerLimit': '1.433', 'upperLimit': '2.573'}, {'value': '1.975', 'groupId': 'OG001', 'lowerLimit': '1.390', 'upperLimit': '2.806'}, {'value': '1.813', 'groupId': 'OG002', 'lowerLimit': '1.330', 'upperLimit': '2.472'}, {'value': '0.963', 'groupId': 'OG003', 'lowerLimit': '0.690', 'upperLimit': '1.344'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-PRP At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.390', 'groupId': 'OG000', 'lowerLimit': '0.279', 'upperLimit': '0.546'}, {'value': '0.446', 'groupId': 'OG001', 'lowerLimit': '0.306', 'upperLimit': '0.651'}, {'value': '0.503', 'groupId': 'OG002', 'lowerLimit': '0.360', 'upperLimit': '0.703'}, {'value': '0.272', 'groupId': 'OG003', 'lowerLimit': '0.193', 'upperLimit': '0.384'}]}]}, {'title': 'ANTI-PRP At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.961', 'groupId': 'OG000', 'lowerLimit': '11.652', 'upperLimit': '24.689'}, {'value': '28.168', 'groupId': 'OG001', 'lowerLimit': '20.580', 'upperLimit': '38.554'}, {'value': '24.549', 'groupId': 'OG002', 'lowerLimit': '16.379', 'upperLimit': '36.795'}, {'value': '12.853', 'groupId': 'OG003', 'lowerLimit': '8.301', 'upperLimit': '19.899'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-Polio 1 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '175.7', 'groupId': 'OG000', 'lowerLimit': '124.5', 'upperLimit': '247.8'}, {'value': '138.2', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '209.8'}, {'value': '190.3', 'groupId': 'OG002', 'lowerLimit': '115.7', 'upperLimit': '312.9'}, {'value': '173.7', 'groupId': 'OG003', 'lowerLimit': '128.9', 'upperLimit': '234.0'}]}]}, {'title': 'ANTI-Polio 2 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '134.3', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '209.1'}, {'value': '114.7', 'groupId': 'OG001', 'lowerLimit': '68.6', 'upperLimit': '192.0'}, {'value': '177.6', 'groupId': 'OG002', 'lowerLimit': '102.5', 'upperLimit': '307.8'}, {'value': '148.4', 'groupId': 'OG003', 'lowerLimit': '101.1', 'upperLimit': '217.9'}]}]}, {'title': 'ANTI-Polio 3 At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '445.7', 'groupId': 'OG000', 'lowerLimit': '290.9', 'upperLimit': '682.9'}, {'value': '432.2', 'groupId': 'OG001', 'lowerLimit': '273.0', 'upperLimit': '684.3'}, {'value': '552.7', 'groupId': 'OG002', 'lowerLimit': '361.1', 'upperLimit': '846.1'}, {'value': '538.6', 'groupId': 'OG003', 'lowerLimit': '413.6', 'upperLimit': '701.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'ANTI-Polio 1 At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '25.9', 'upperLimit': '67.3'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '35.6', 'upperLimit': '95.6'}, {'value': '55.5', 'groupId': 'OG002', 'lowerLimit': '33.9', 'upperLimit': '90.9'}, {'value': '55.4', 'groupId': 'OG003', 'lowerLimit': '38.3', 'upperLimit': '80.1'}]}]}, {'title': 'ANTI-Polio 1 At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1116.0', 'groupId': 'OG000', 'lowerLimit': '696.1', 'upperLimit': '1789.3'}, {'value': '1222.0', 'groupId': 'OG001', 'lowerLimit': '737.1', 'upperLimit': '2026.1'}, {'value': '1149.6', 'groupId': 'OG002', 'lowerLimit': '764.3', 'upperLimit': '1729.0'}, {'value': '1233.2', 'groupId': 'OG003', 'lowerLimit': '898.9', 'upperLimit': '1691.9'}]}]}, {'title': 'ANTI-Polio 2 At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.4', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '76.0'}, {'value': '55.9', 'groupId': 'OG001', 'lowerLimit': '35.6', 'upperLimit': '87.8'}, {'value': '61.0', 'groupId': 'OG002', 'lowerLimit': '40.2', 'upperLimit': '92.7'}, {'value': '66.8', 'groupId': 'OG003', 'lowerLimit': '48.6', 'upperLimit': '91.9'}]}]}, {'title': 'ANTI-Polio 2 At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1998.1', 'groupId': 'OG000', 'lowerLimit': '1415.0', 'upperLimit': '2821.5'}, {'value': '2332.2', 'groupId': 'OG001', 'lowerLimit': '1739.0', 'upperLimit': '3127.6'}, {'value': '2048.3', 'groupId': 'OG002', 'lowerLimit': '1484.6', 'upperLimit': '2825.9'}, {'value': '2284.8', 'groupId': 'OG003', 'lowerLimit': '1705.1', 'upperLimit': '3061.6'}]}]}, {'title': 'ANTI-Polio 3 At Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '167.7', 'groupId': 'OG000', 'lowerLimit': '113.3', 'upperLimit': '248.3'}, {'value': '104.9', 'groupId': 'OG001', 'lowerLimit': '68.7', 'upperLimit': '160.2'}, {'value': '125.4', 'groupId': 'OG002', 'lowerLimit': '81.2', 'upperLimit': '193.6'}, {'value': '93.1', 'groupId': 'OG003', 'lowerLimit': '66.2', 'upperLimit': '130.9'}]}]}, {'title': 'ANTI-Polio 3 At Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2995.8', 'groupId': 'OG000', 'lowerLimit': '2081.1', 'upperLimit': '4312.6'}, {'value': '3626.3', 'groupId': 'OG001', 'lowerLimit': '2623.6', 'upperLimit': '5012.2'}, {'value': '2696.8', 'groupId': 'OG002', 'lowerLimit': '1913.7', 'upperLimit': '3800.4'}, {'value': '2820.0', 'groupId': 'OG003', 'lowerLimit': '2127.9', 'upperLimit': '3737.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Any Pain, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, post D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Any Pain, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, post D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any Pain, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling, post D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course', 'description': 'Assessed local symptoms were pain, redness and swelling at injection site. 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 against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 7-day (Days 0-6) period after booster vaccination', 'description': 'Assessed local symptoms were pain, redness and swelling at injection site. 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 of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Related Drowsiness', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Related Irritability', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}, {'title': 'Any Loss Appet', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Loss Appet.', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Related Loss Appet.', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Related Fever', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 7-day (Days 0-6) period post vaccination after booster vaccination', 'description': 'Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \\[≥\\] 38 degrees Celsius \\[°C\\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary 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 of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '61', '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 vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '34', '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 of Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'OG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'OG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (Months 0-11)', 'description': 'An 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 hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an 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 vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'FG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'FG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'FG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}], 'periods': [{'title': 'Primary Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '142'}, {'groupId': 'FG002', 'numSubjects': '145'}, {'groupId': 'FG003', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '142'}, {'groupId': 'FG002', 'numSubjects': '144'}, {'groupId': 'FG003', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Booster Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Not all subjects completing the primary vaccination returned for the booster phase.', 'groupId': 'FG000', 'numSubjects': '144'}, {'comment': 'Not all subjects completing the primary vaccination returned for the booster phase.', 'groupId': 'FG001', 'numSubjects': '140'}, {'comment': 'Not all subjects completing the primary vaccination returned for the booster phase.', 'groupId': 'FG002', 'numSubjects': '140'}, {'comment': 'Not all subjects completing the primary vaccination returned for the booster phase.', 'groupId': 'FG003', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '140'}, {'groupId': 'FG003', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 576 subjects were initially enrolled in the study. Of these, one subject was older than protocol defined age range for the first vaccination, and therefore did not receive any vaccination.', 'preAssignmentDetails': 'The study duration is approximately 10 to 14 months depending on age at recruitment and age at booster vaccination. 2 Phases in the study: Primary Phase when subjects received a 3-dose of pneumococcal vaccine co-administered with Infanrix hexa™ (Months 0, 1, 2), and Booster Phase when subjects received one dose of the same vaccines (Month 10).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '575', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '10PP-LD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'BG001', 'title': '10PP-HD/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.'}, {'id': 'BG002', 'title': 'Synflorix/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.'}, {'id': 'BG003', 'title': 'Prevnar 13/Infanrix Hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '2.49', 'groupId': 'BG000'}, {'value': '10.1', 'spread': '2.70', 'groupId': 'BG001'}, {'value': '10.1', 'spread': '2.61', 'groupId': 'BG002'}, {'value': '10.2', 'spread': '2.64', 'groupId': 'BG003'}, {'value': '10.2', 'spread': '2.61', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '268', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '307', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 576}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'dispFirstSubmitDate': '2012-11-16', 'completionDateStruct': {'date': '2012-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2010-09-16', 'dispFirstSubmitQcDate': '2012-11-16', 'resultsFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2010-09-16', 'dispFirstPostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-05', 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study', 'timeFrame': 'Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course', 'description': 'Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to \\[\\>=\\] 38 degrees Celsius \\[°C\\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (\\>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).'}, {'measure': 'Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses', 'description': 'Grade 3 fever was defined as fever by rectal measurement \\> 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.'}, {'measure': 'Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses', 'description': 'Grade 3 fever was defined as fever by rectal measurement \\>40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.'}], 'secondaryOutcomes': [{'measure': 'Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': '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 seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.'}, {'measure': 'Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': '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 seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', '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 enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', '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 enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', '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, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Primary Phase of the study.'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', '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, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.'}, {'measure': 'Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.'}, {'measure': 'Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.'}, {'measure': 'Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.'}, {'measure': 'Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study. \\* A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™.'}, {'measure': 'Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.'}, {'measure': 'Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study', 'timeFrame': 'At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.'}, {'measure': 'Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study', 'timeFrame': 'At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)', 'description': 'Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study', 'timeFrame': 'Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course', 'description': 'Assessed local symptoms were pain, redness and swelling at injection site. 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 - Booster Phase of the Study', 'timeFrame': 'Within the 7-day (Days 0-6) period after booster vaccination', 'description': 'Assessed local symptoms were pain, redness and swelling at injection site. 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, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study', 'timeFrame': 'Within the 7-day (Days 0-6) period post vaccination after booster vaccination', 'description': 'Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \\[≥\\] 38 degrees Celsius \\[°C\\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (\\>) 40.0°C.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs) - 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 Unsolicited Adverse Events (AEs) - 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 Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period (Months 0-11)', 'description': 'An 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 hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.'}]}, 'conditionsModule': {'keywords': ['Haemophilus influenzae', 'Streptococcus pneumoniae', 'immunogenicity', 'Pneumococcal vaccine', 'infants', 'safety'], 'conditions': ['Infections, Streptococcal']}, 'referencesModule': {'references': [{'pmid': '28729019', 'type': 'BACKGROUND', 'citation': 'Prymula R, Szenborn L, Silfverdal SA, Wysocki J, Albrecht P, Traskine M, Gardev A, Song Y, Borys D. Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: Results from a randomized phase II study in infants. Vaccine. 2017 Aug 16;35(35 Pt B):4603-4611. doi: 10.1016/j.vaccine.2017.07.008. Epub 2017 Jul 17.'}]}, 'descriptionModule': {'briefSummary': "This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.", 'detailedDescription': "This study will assess the safety, reactogenicity, immunogenicity and persistence of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A \\[high dose (HD) or low dose (LD)\\] given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age when co-administered with Infanrix hexa™ and compared to the vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered with the Infanrix hexa™ vaccine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol\n* Male or female between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.\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 36 to 42 weeks inclusive.\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 not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.\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* Previous vaccination against S. pneumoniae since birth.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or any chronic illness.\n* History of any neurologic disorders or seizures.\n* Acute disease and/or fever at the time of enrolment.\n* Fever is defined as temperature \\>= 38.0°C on rectal setting or \\>= 37.5°C on oral or axillary setting.\n* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.\n* Administration of immunoglobulins and/ or any blood products since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.'}, 'identificationModule': {'nctId': 'NCT01204658', 'briefTitle': 'Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants", 'orgStudyIdInfo': {'id': '113994'}, 'secondaryIdInfos': [{'id': '2010-019730-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10PP-LD/Infanrix hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.', 'interventionNames': ['Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1)', 'Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)']}, {'type': 'EXPERIMENTAL', 'label': '10PP-HD/Infanrix hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.', 'interventionNames': ['Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)', 'Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Synflorix/Infanrix hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.', 'interventionNames': ['Biological: Synflorix', 'Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevnar 13/Infanrix hexa Group', 'description': 'This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.', 'interventionNames': ['Biological: Prevenar 13', 'Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)']}], 'interventions': [{'name': 'Pneumococcal vaccine GSK 2189242A (LD formulation 1)', 'type': 'BIOLOGICAL', 'otherNames': ['GSK 2189242A; 10PP-LD'], 'description': 'Intramuscular injection', 'armGroupLabels': ['10PP-LD/Infanrix hexa Group']}, {'name': 'Pneumococcal vaccine GSK 2189242A (HD formulation 2)', 'type': 'BIOLOGICAL', 'otherNames': ['GSK 2189242A; 10PP-HD'], 'description': 'Intramuscular injection', 'armGroupLabels': ['10PP-HD/Infanrix hexa Group']}, {'name': 'Synflorix', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['Synflorix/Infanrix hexa Group']}, {'name': 'Prevenar 13', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['Prevnar 13/Infanrix hexa Group']}, {'name': 'Infanrix Hexa (DTPa-HBV-IPV/Hib)', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['10PP-HD/Infanrix hexa Group', '10PP-LD/Infanrix hexa Group', 'Prevnar 13/Infanrix hexa Group', 'Synflorix/Infanrix hexa Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '256 01', 'city': 'Benešov', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.78162, 'lon': 14.68697}}, {'zip': '613 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '405 01', 'city': 'Děčín', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.78215, 'lon': 14.21478}}, {'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 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'lon': 20.25972}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', '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. 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