Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT00307034
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2006-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods.', 'description': 'Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.', 'eventGroups': [{'id': 'EG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.', 'otherNumAtRisk': 175, 'otherNumAffected': 173, 'seriousNumAtRisk': 175, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.', 'otherNumAtRisk': 176, 'otherNumAffected': 175, 'seriousNumAtRisk': 176, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Cough (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 110}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Redness (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 135}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Swelling (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 105}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 93}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Redness (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 115}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Swelling (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 99}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Drowsiness (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 130}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fever- rectal (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 116}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Irritability (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 158}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Loss of appetite (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 88}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Drowsiness (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fever- rectal (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 78}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Irritability (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 104}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Loss of appetite (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Otitis media (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Asthma (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Febrile convulsion (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dermatitis allergic (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory syncytial virus infection (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchopneumonia (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis viral (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lower respiratory tract infection (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Salmonellosis (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tracheitis (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Viral infection (Primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Otitis media (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection (Booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-1 (N= 153, 151)', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}, {'title': 'Anti-4 (N=153, 153)', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Anti-5 (N=152, 149)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}, {'title': 'Anti-6B (N=149, 149)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Anti-7F (N=153, 152)', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Anti-9V (N=152, 153)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Anti-14 (N=152, 152)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Anti-18C (N=152, 153)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Anti-19F (N=152, 152)', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Anti-23F (N=153, 152)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month post-dose 2 (Month 3) administration of Synflorix™ vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-1, Month 9 (N= 149, 147)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Anti-1, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Anti-4, Month 9 (N= 152, 149)', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'Anti-4, Month 10 (N=155, 147)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Anti-5, Month 9 (N= 148, 149)', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'Anti-5, Month 10 (N=155, 147)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Anti-6B, Month 9 (N= 154, 148)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Anti-6B, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Anti-7F, Month 9 (N= 151, 149)', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Anti-7F, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Anti-9V, Month 9 (N= 153, 149)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Anti-9V, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Anti-14, Month 9 (N= 151, 149)', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Anti-14, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}, {'title': 'Anti-18C, Month 9 (N= 154, 149)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Anti-18C, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Anti-19F, Month 9 (N= 153, 149)', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}, {'title': 'Anti-19F, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Anti-23F, Month 9 (N= 151, 148)', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Anti-23F, Month 10 (N=154, 147)', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-1, Month 3 (N= 153, 151)', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.18'}, {'value': '1.23', 'groupId': 'OG001', 'lowerLimit': '1.07', 'upperLimit': '1.42'}]}]}, {'title': 'Anti-1, Month 9 (N= 149, 147)', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '0.24'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.34'}]}]}, {'title': 'Anti-1, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '2.15'}, {'value': '1.88', 'groupId': 'OG001', 'lowerLimit': '1.62', 'upperLimit': '2.17'}]}]}, {'title': 'Anti-4, Month 3 (N= 153, 153)', 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '1.21', 'upperLimit': '1.55'}, {'value': '1.71', 'groupId': 'OG001', 'lowerLimit': '1.47', 'upperLimit': '1.99'}]}]}, {'title': 'Anti-4, Month 9 (N= 152, 149)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.46'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.56', 'upperLimit': '0.73'}]}]}, {'title': 'Anti-4, Month 10 (N=155, 147)', 'categories': [{'measurements': [{'value': '3.06', 'groupId': 'OG000', 'lowerLimit': '2.68', 'upperLimit': '3.49'}, {'value': '3.47', 'groupId': 'OG001', 'lowerLimit': '3.03', 'upperLimit': '3.98'}]}]}, {'title': 'Anti-5, Month 3 (N= 152, 149)', 'categories': [{'measurements': [{'value': '1.32', 'groupId': 'OG000', 'lowerLimit': '1.14', 'upperLimit': '1.52'}, {'value': '1.85', 'groupId': 'OG001', 'lowerLimit': '1.63', 'upperLimit': '2.1'}]}]}, {'title': 'Anti-5, Month 9 (N= 148, 149)', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.37', 'upperLimit': '0.5'}, {'value': '0.59', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '0.68'}]}]}, {'title': 'Anti-5, Month 10 (N=155, 147)', 'categories': [{'measurements': [{'value': '2.65', 'groupId': 'OG000', 'lowerLimit': '2.31', 'upperLimit': '3.03'}, {'value': '3.21', 'groupId': 'OG001', 'lowerLimit': '2.81', 'upperLimit': '3.67'}]}]}, {'title': 'Anti-6B, Month 3 (N= 149, 149)', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.24'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '0.38'}]}]}, {'title': 'Anti-6B, Month 9 (N= 154, 148)', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.35'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.54'}]}]}, {'title': 'Anti-6B, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '1.41'}, {'value': '1.85', 'groupId': 'OG001', 'lowerLimit': '1.54', 'upperLimit': '2.22'}]}]}, {'title': 'Anti-7F, Month 3 (N= 153, 152)', 'categories': [{'measurements': [{'value': '1.28', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.46'}, {'value': '2.14', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.4'}]}]}, {'title': 'Anti-7F, Month 9 (N= 151, 149)', 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.63'}, {'value': '0.92', 'groupId': 'OG001', 'lowerLimit': '0.81', 'upperLimit': '1.05'}]}]}, {'title': 'Anti-7F, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '2.81', 'groupId': 'OG000', 'lowerLimit': '2.51', 'upperLimit': '3.15'}, {'value': '3.88', 'groupId': 'OG001', 'lowerLimit': '3.45', 'upperLimit': '4.37'}]}]}, {'title': 'Anti-9V, Month 3 (N= 152, 153)', 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.05'}, {'value': '1.47', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '1.68'}]}]}, {'title': 'Anti-9V, Month 9 (N= 153, 149)', 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '0.6'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '0.99'}]}]}, {'title': 'Anti-9V, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '3.37'}, {'value': '3.97', 'groupId': 'OG001', 'lowerLimit': '3.49', 'upperLimit': '4.5'}]}]}, {'title': 'Anti-14, Month 3 (N= 152, 152)', 'categories': [{'measurements': [{'value': '1.72', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '2.05'}, {'value': '2.57', 'groupId': 'OG001', 'lowerLimit': '2.22', 'upperLimit': '2.97'}]}]}, {'title': 'Anti-14, Month 9 (N= 151, 149)', 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.93'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '1.27', 'upperLimit': '1.85'}]}]}, {'title': 'Anti-14, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '4.19', 'groupId': 'OG000', 'lowerLimit': '3.62', 'upperLimit': '4.85'}, {'value': '5.47', 'groupId': 'OG001', 'lowerLimit': '4.68', 'upperLimit': '6.4'}]}]}, {'title': 'Anti-18C, Month 3 (N= 152, 153)', 'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '1.06', 'upperLimit': '1.51'}, {'value': '3.42', 'groupId': 'OG001', 'lowerLimit': '2.87', 'upperLimit': '4.07'}]}]}, {'title': 'Anti-18C, Month 9 (N= 154, 149)', 'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.69'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '1.35'}]}]}, {'title': 'Anti-18C, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '6.24', 'groupId': 'OG000', 'lowerLimit': '5.43', 'upperLimit': '7.18'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '6.08', 'upperLimit': '8.52'}]}]}, {'title': 'Anti-19F, Month 3 (N= 152, 152)', 'categories': [{'measurements': [{'value': '2.43', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '2.98'}, {'value': '4.43', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '5.45'}]}]}, {'title': 'Anti-19F, Month 9 (N= 153, 149)', 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.25'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '2.04'}]}]}, {'title': 'Anti-19F, Month 10 (N=156, 147)', 'categories': [{'measurements': [{'value': '5.58', 'groupId': 'OG000', 'lowerLimit': '4.65', 'upperLimit': '6.69'}, {'value': '6.95', 'groupId': 'OG001', 'lowerLimit': '5.92', 'upperLimit': '8.17'}]}]}, {'title': 'Anti-23F, Month 3 (N= 153, 152)', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.47'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.63'}]}]}, {'title': 'Anti-23F, Month 9 (N= 151, 148)', 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.4'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.54'}]}]}, {'title': 'Anti-23F, Month 10 (N=154, 147)', 'categories': [{'measurements': [{'value': '2.41', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '2.94'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '2.31', 'upperLimit': '3.35'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F 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 and Booster Phases of the study.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Opsono-1, Month 3 (N= 130, 132)', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '29.1'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '35.4'}]}]}, {'title': 'Opsono-1, Month 9 (N= 136, 134)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '5.8'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '8.3'}]}]}, {'title': 'Opsono-1, Month 10 (N=131, 126)', 'categories': [{'measurements': [{'value': '109.9', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '158.7'}, {'value': '100.6', 'groupId': 'OG001', 'lowerLimit': '68.9', 'upperLimit': '146.9'}]}]}, {'title': 'Opsono-4, Month 3 (N= 134, 132)', 'categories': [{'measurements': [{'value': '462.6', 'groupId': 'OG000', 'lowerLimit': '410.4', 'upperLimit': '521.4'}, {'value': '758.9', 'groupId': 'OG001', 'lowerLimit': '647.8', 'upperLimit': '888.9'}]}]}, {'title': 'Opsono-4, Month 9 (N= 104, 114)', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '19.6'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '27.2'}]}]}, {'title': 'Opsono-4, Month 10 (N=125, 101)', 'categories': [{'measurements': [{'value': '634.6', 'groupId': 'OG000', 'lowerLimit': '496.3', 'upperLimit': '811.3'}, {'value': '1204', 'groupId': 'OG001', 'lowerLimit': '990.7', 'upperLimit': '1463.2'}]}]}, {'title': 'Opsono-5, Month 3 (N= 132, 130)', 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '37.7', 'upperLimit': '61.8'}, {'value': '68.4', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '86.5'}]}]}, {'title': 'Opsono-5, Month 9 (N= 133, 135)', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '12'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '13.4'}]}]}, {'title': 'Opsono-5, Month 10 (N=133, 121)', 'categories': [{'measurements': [{'value': '102.1', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '137.6'}, {'value': '157.2', 'groupId': 'OG001', 'lowerLimit': '123.1', 'upperLimit': '200.7'}]}]}, {'title': 'Opsono-6B, Month 3 (N= 125, 126)', 'categories': [{'measurements': [{'value': '157.8', 'groupId': 'OG000', 'lowerLimit': '104.7', 'upperLimit': '237.8'}, {'value': '379.6', 'groupId': 'OG001', 'lowerLimit': '272.4', 'upperLimit': '529.1'}]}]}, {'title': 'Opsono-6B, Month 9 (N= 121, 124)', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '90.4'}, {'value': '62.9', 'groupId': 'OG001', 'lowerLimit': '40.2', 'upperLimit': '98.5'}]}]}, {'title': 'Opsono-6B, Month 10 (N=132, 103)', 'categories': [{'measurements': [{'value': '220.3', 'groupId': 'OG000', 'lowerLimit': '146.9', 'upperLimit': '330.3'}, {'value': '468.5', 'groupId': 'OG001', 'lowerLimit': '311.6', 'upperLimit': '704.3'}]}]}, {'title': 'Opsono-7F, Month 3 (N= 127, 131)', 'categories': [{'measurements': [{'value': '844.8', 'groupId': 'OG000', 'lowerLimit': '591.4', 'upperLimit': '1206.7'}, {'value': '2176.5', 'groupId': 'OG001', 'lowerLimit': '1759.2', 'upperLimit': '2692.7'}]}]}, {'title': 'Opsono-7F, Month 9 (N= 113, 126)', 'categories': [{'measurements': [{'value': '148.5', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '246.4'}, {'value': '380.6', 'groupId': 'OG001', 'lowerLimit': '253', 'upperLimit': '572.6'}]}]}, {'title': 'Opsono-7F, Month 10 (N=128, 109)', 'categories': [{'measurements': [{'value': '1843.4', 'groupId': 'OG000', 'lowerLimit': '1494.2', 'upperLimit': '2274.1'}, {'value': '3290.6', 'groupId': 'OG001', 'lowerLimit': '2709.1', 'upperLimit': '3996.8'}]}]}, {'title': 'Opsono-9V, Month 3 (N= 134, 132)', 'categories': [{'measurements': [{'value': '875.1', 'groupId': 'OG000', 'lowerLimit': '732', 'upperLimit': '1046.1'}, {'value': '1343.4', 'groupId': 'OG001', 'lowerLimit': '1130.8', 'upperLimit': '1596'}]}]}, {'title': 'Opsono-9V, Month 9 (N= 120, 134)', 'categories': [{'measurements': [{'value': '266.8', 'groupId': 'OG000', 'lowerLimit': '205.1', 'upperLimit': '347.1'}, {'value': '322.2', 'groupId': 'OG001', 'lowerLimit': '256.4', 'upperLimit': '405.1'}]}]}, {'title': 'Opsono-9V, Month 10 (N=129, 109)', 'categories': [{'measurements': [{'value': '1068.1', 'groupId': 'OG000', 'lowerLimit': '874.7', 'upperLimit': '1304.2'}, {'value': '1706.9', 'groupId': 'OG001', 'lowerLimit': '1438.5', 'upperLimit': '2025.3'}]}]}, {'title': 'Opsono-14, Month 3 (N= 132, 131)', 'categories': [{'measurements': [{'value': '692.6', 'groupId': 'OG000', 'lowerLimit': '559.1', 'upperLimit': '858'}, {'value': '1125.3', 'groupId': 'OG001', 'lowerLimit': '946.2', 'upperLimit': '1338.3'}]}]}, {'title': 'Opsono-14, Month 9 (N= 102, 123)', 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '84'}, {'value': '157.3', 'groupId': 'OG001', 'lowerLimit': '108.5', 'upperLimit': '228.1'}]}]}, {'title': 'Opsono-14, Month 10 (N=107, 101)', 'categories': [{'measurements': [{'value': '835.5', 'groupId': 'OG000', 'lowerLimit': '672.1', 'upperLimit': '1038.5'}, {'value': '1280.7', 'groupId': 'OG001', 'lowerLimit': '1054.5', 'upperLimit': '1555.5'}]}]}, {'title': 'Opsono-18C, Month 3 (N= 134, 131)', 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '42.9', 'upperLimit': '73.7'}, {'value': '218.6', 'groupId': 'OG001', 'lowerLimit': '176.1', 'upperLimit': '271.4'}]}]}, {'title': 'Opsono-18C, Month 9 (N= 122, 126)', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '10.7'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '22.8'}]}]}, {'title': 'Opsono-18C, Month 10 (N=136, 130)', 'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000', 'lowerLimit': '259.1', 'upperLimit': '420.3'}, {'value': '490.8', 'groupId': 'OG001', 'lowerLimit': '395.3', 'upperLimit': '609.4'}]}]}, {'title': 'Opsono-19F, Month 3 (N= 131, 128)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000', 'lowerLimit': '74.9', 'upperLimit': '136'}, {'value': '356.7', 'groupId': 'OG001', 'lowerLimit': '263.2', 'upperLimit': '483.4'}]}]}, {'title': 'Opsono-19F, Month 9 (N= 130, 134)', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '21.1'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '24.5', 'upperLimit': '40.8'}]}]}, {'title': 'Opsono-19F, Month 10 (N=131, 129)', 'categories': [{'measurements': [{'value': '251.3', 'groupId': 'OG000', 'lowerLimit': '193.4', 'upperLimit': '326.6'}, {'value': '734.7', 'groupId': 'OG001', 'lowerLimit': '568.3', 'upperLimit': '949.8'}]}]}, {'title': 'Opsono-23F, Month 3 (N= 131, 129)', 'categories': [{'measurements': [{'value': '489.7', 'groupId': 'OG000', 'lowerLimit': '342.6', 'upperLimit': '700'}, {'value': '1233.7', 'groupId': 'OG001', 'lowerLimit': '991.7', 'upperLimit': '1534.7'}]}]}, {'title': 'Opsono-23F, Month 9 (N= 112, 133)', 'categories': [{'measurements': [{'value': '190.7', 'groupId': 'OG000', 'lowerLimit': '115.2', 'upperLimit': '315.6'}, {'value': '150.7', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '236.8'}]}]}, {'title': 'Opsono-23F, Month 10 (N=134, 121)', 'categories': [{'measurements': [{'value': '1047.3', 'groupId': 'OG000', 'lowerLimit': '748.1', 'upperLimit': '1466.3'}, {'value': '1528.9', 'groupId': 'OG001', 'lowerLimit': '1171.2', 'upperLimit': '1996'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Seropositivity status was defined as the opsonophacocytic activity against pneumococcal serotypes greater than or egual to (≥) the value of 8. The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).This outcome concerns results for the Primary and Booster Phases of the study.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Protein D (Anti-PD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-PD, Month 3 (N=149, 148)', 'categories': [{'measurements': [{'value': '861.8', 'groupId': 'OG000', 'lowerLimit': '740.4', 'upperLimit': '1003.1'}, {'value': '1223.3', 'groupId': 'OG001', 'lowerLimit': '1066.5', 'upperLimit': '1403.2'}]}]}, {'title': 'Anti-PD, Month 9 (N= 151, 148)', 'categories': [{'measurements': [{'value': '349.7', 'groupId': 'OG000', 'lowerLimit': '294.2', 'upperLimit': '415.7'}, {'value': '499.8', 'groupId': 'OG001', 'lowerLimit': '425.3', 'upperLimit': '587.2'}]}]}, {'title': 'Anti-PD, Month 10 (N= 154, 146)', 'categories': [{'measurements': [{'value': '1629.8', 'groupId': 'OG000', 'lowerLimit': '1346.4', 'upperLimit': '1972.8'}, {'value': '2113', 'groupId': 'OG001', 'lowerLimit': '1808.9', 'upperLimit': '2468.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Anti-protein D concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).Seropositivity status was defined as Anti-PD antibody concentrations greater than or equal to (≥) the value of 100 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-D, Month 3 (N=154, 151)', 'categories': [{'measurements': [{'value': '1.791', 'groupId': 'OG000', 'lowerLimit': '1.503', 'upperLimit': '2.133'}, {'value': '3.123', 'groupId': 'OG001', 'lowerLimit': '2.621', 'upperLimit': '3.723'}]}]}, {'title': 'Anti-D, Month 9 (N= 154, 148)', 'categories': [{'measurements': [{'value': '0.326', 'groupId': 'OG000', 'lowerLimit': '0.275', 'upperLimit': '0.386'}, {'value': '0.725', 'groupId': 'OG001', 'lowerLimit': '0.622', 'upperLimit': '0.846'}]}]}, {'title': 'Anti-D, Month 10 (N= 156, 148)', 'categories': [{'measurements': [{'value': '5.423', 'groupId': 'OG000', 'lowerLimit': '4.815', 'upperLimit': '6.108'}, {'value': '8.262', 'groupId': 'OG001', 'lowerLimit': '7.339', 'upperLimit': '9.301'}]}]}, {'title': 'Anti-T, Month 3 (N=154, 151)', 'categories': [{'measurements': [{'value': '2.504', 'groupId': 'OG000', 'lowerLimit': '2.17', 'upperLimit': '2.89'}, {'value': '4.602', 'groupId': 'OG001', 'lowerLimit': '4.062', 'upperLimit': '5.213'}]}]}, {'title': 'Anti-T, Month 9 (N= 153, 149)', 'categories': [{'measurements': [{'value': '0.565', 'groupId': 'OG000', 'lowerLimit': '0.487', 'upperLimit': '0.656'}, {'value': '1.191', 'groupId': 'OG001', 'lowerLimit': '1.055', 'upperLimit': '1.344'}]}]}, {'title': 'Anti-T, Month 10 (N= 156, 148)', 'categories': [{'measurements': [{'value': '7.678', 'groupId': 'OG000', 'lowerLimit': '6.997', 'upperLimit': '8.425'}, {'value': '9.597', 'groupId': 'OG001', 'lowerLimit': '8.749', 'upperLimit': '10.526'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Concentrations of antibodies are presented as geometric mean concentrations, expressed as international units per milliliter (IU/mL). Seroprotection status was defined as anti-diphteria and anti-tetanus toxoid antibody concentrations greater than or equal to (≥) the value of 0.1 IU/mL. This outcome concerns results for the Primary and Booster Phases of the study.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-PRP, Month 3 (N=146, 147)', 'categories': [{'measurements': [{'value': '1.179', 'groupId': 'OG000', 'lowerLimit': '0.893', 'upperLimit': '1.556'}, {'value': '2.186', 'groupId': 'OG001', 'lowerLimit': '1.648', 'upperLimit': '2.9'}]}]}, {'title': 'Anti-PRP, Month 9 (N=150, 148)', 'categories': [{'measurements': [{'value': '0.431', 'groupId': 'OG000', 'lowerLimit': '0.349', 'upperLimit': '0.532'}, {'value': '0.777', 'groupId': 'OG001', 'lowerLimit': '0.613', 'upperLimit': '0.984'}]}]}, {'title': 'Anti-PRP, Month 10 (N=155, 147)', 'categories': [{'measurements': [{'value': '16.943', 'groupId': 'OG000', 'lowerLimit': '13.485', 'upperLimit': '21.287'}, {'value': '21.654', 'groupId': 'OG001', 'lowerLimit': '17.263', 'upperLimit': '27.161'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix™ vaccine', 'description': 'Concentrations of antibodies are presented as geometric mean concentrations, expressed as micrograms per milliliter (μg/mL). Seroprotection status was defined as anti-polyribosyl ribitol phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) the cut-off values of 0.15 μg/mL and ≥ 1.0 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-PT, Month 3 (N=145, 144)', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '39.6'}, {'value': '33.8', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '37.9'}]}]}, {'title': 'Anti-PT, Month 9 (N=144, 145)', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '11.1'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '11.7'}]}]}, {'title': 'Anti-PT, Month 10 (N=149, 145)', 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '70.5', 'upperLimit': '86.8'}, {'value': '65.5', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '73.1'}]}]}, {'title': 'Anti-FHA, Month 3 (N=145, 144)', 'categories': [{'measurements': [{'value': '166.7', 'groupId': 'OG000', 'lowerLimit': '150.1', 'upperLimit': '185.2'}, {'value': '142.2', 'groupId': 'OG001', 'lowerLimit': '125.6', 'upperLimit': '161.1'}]}]}, {'title': 'Anti-FHA, Month 9 (N=144, 145)', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '52.6'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '53.6'}]}]}, {'title': 'Anti-FHA, Month 10 (N=149, 144)', 'categories': [{'measurements': [{'value': '360.3', 'groupId': 'OG000', 'lowerLimit': '323.7', 'upperLimit': '401'}, {'value': '276.6', 'groupId': 'OG001', 'lowerLimit': '249.4', 'upperLimit': '306.7'}]}]}, {'title': 'Anti-PRN , Month 3 (N=145, 144)', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000', 'lowerLimit': '69.6', 'upperLimit': '101.1'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '74.1', 'upperLimit': '106.8'}]}]}, {'title': 'Anti-PRN, Month 9 (N=144, 145)', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '16.6'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '21.8'}]}]}, {'title': 'Anti-PRN, Month 10 (N=150, 147)', 'categories': [{'measurements': [{'value': '275.5', 'groupId': 'OG000', 'lowerLimit': '235.9', 'upperLimit': '321.7'}, {'value': '209.3', 'groupId': 'OG001', 'lowerLimit': '181.8', 'upperLimit': '241'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Concentrations of antibodies are presented as geometric mean concentrations, expressed as enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity status was defined as anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) the cut-off value of 5 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-HBs, Month 3 (N=37, 38)', 'categories': [{'measurements': [{'value': '293.7', 'groupId': 'OG000', 'lowerLimit': '195.9', 'upperLimit': '440.5'}, {'value': '478.6', 'groupId': 'OG001', 'lowerLimit': '294.8', 'upperLimit': '776.9'}]}]}, {'title': 'Anti-HBs, Month 9 (N=40, 46)', 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '128.2'}, {'value': '156.6', 'groupId': 'OG001', 'lowerLimit': '106.4', 'upperLimit': '230.4'}]}]}, {'title': 'Anti-HBs, Month 10 (N=27, 28)', 'categories': [{'measurements': [{'value': '1892.3', 'groupId': 'OG000', 'lowerLimit': '1012.2', 'upperLimit': '3537.6'}, {'value': '2922.4', 'groupId': 'OG001', 'lowerLimit': '2010.4', 'upperLimit': '4248.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Concentrations of antibodies are presented as geometric mean concentrations, expressed as milli international units per milliliter (mIU/mL). Seroprotection status was defined as anti-hepatitis B surface antigen (anti-HBs) antibody concentrations greater than or equal to (≥) the cut-off value of 10 mIU/mL. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-Polio 1, Month 3 (N=47, 57)', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '56.3', 'upperLimit': '139.1'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '63.4', 'upperLimit': '154.8'}]}]}, {'title': 'Anti-Polio 1, Month 9 (N=45, 39)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': '38.8'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '23.1'}]}]}, {'title': 'Anti-Polio 1, Month 10 (N=20, 15)', 'categories': [{'measurements': [{'value': '1006.4', 'groupId': 'OG000', 'lowerLimit': '541.8', 'upperLimit': '1869.4'}, {'value': '645', 'groupId': 'OG001', 'lowerLimit': '399.4', 'upperLimit': '1041.7'}]}]}, {'title': 'Anti-Polio 2, Month 3 (N=47, 59)', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000', 'lowerLimit': '36.8', 'upperLimit': '90.6'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '65.6'}]}]}, {'title': 'Anti-Polio 2, Month 9 (N=44, 40)', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '20.9'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '16.4'}]}]}, {'title': 'Anti-Polio 2, Month 10 (N=17, 14)', 'categories': [{'measurements': [{'value': '522.4', 'groupId': 'OG000', 'lowerLimit': '235.7', 'upperLimit': '1157.7'}, {'value': '512.2', 'groupId': 'OG001', 'lowerLimit': '186.4', 'upperLimit': '1407.7'}]}]}, {'title': 'Anti-Polio 3, Month 3 (N=50, 57)', 'categories': [{'measurements': [{'value': '165.6', 'groupId': 'OG000', 'lowerLimit': '109.3', 'upperLimit': '250.8'}, {'value': '161', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '262.8'}]}]}, {'title': 'Anti-Polio 3, Month 9 (N=44, 38)', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '23.2'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '24.1'}]}]}, {'title': 'Anti-Polio 3, Month 10 (N=5, 11)', 'categories': [{'measurements': [{'value': '1910.8', 'groupId': 'OG000', 'lowerLimit': '257.4', 'upperLimit': '14185.3'}, {'value': '961.4', 'groupId': 'OG001', 'lowerLimit': '388.3', 'upperLimit': '2380.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Titers of antibodies are presented as geometric mean titers. Seroprotection status was defined as anti-polio types 1, 2 and 3 (Anti-polio 1, 2 and 3) antibody titers greater than or equal to (≥) the value of 8. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Anti-PT, Pre-booster status S- (N=20, 23)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PT, Pre-booster status S+ (N=117, 117)', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PT, Pre-booster status Total (N=137, 140)', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, Pre-booster status S- (N=0, 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, Pre-booster status S+ (N=137, 138)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, Pre-booster status Total (N=137, 139)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, Pre-booster status S- (N=35, 21)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, Pre-booster status S+ (N=102, 121)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, Pre-booster status Total (N=137, 142)', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One month after (Month 9) the administration of the booster dose of Synflorix™ vaccine', 'description': 'Booster vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN), defined as the appearance of antibodies in subjects who were seronegative (Pre-booster status S-) (i.e., with antibody concentrations \\< 5 EL.U/mL) just before booster dose, and at least two-fold increase of pre-vaccination antibody concentrations in those who were seropositive (Pre-booster status S+) (i.e., with antibody concentrations ≥ 5 EL.U/mL) just before booster dose.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Any Pain, across doses (N=175; 176)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, across doses (N=175; 176)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, across doses (N=175; 176)', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, across doses (N=175; 176)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, across doses (N=175; 176)', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, across doses (N=175; 176)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine', 'description': 'Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\\>) 30 millimeters (mm). Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'title': 'Any Drowsiness, across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Any Irr./Fuss., across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irr./Fuss., across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Related Irr./Fuss., across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss Appet., across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss Appet., across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss Appet., across doses (N=175, 176)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Any Irr./Fuss., post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irr./Fuss., post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Irr./Fuss., post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss Appet., post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss Appet., post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss Appet., post Booster (N=174, 169)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine', 'description': 'Assessed solicited general symptoms were drowsiness, irritability/fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and fever (rectal temperature higher than \\[≥\\] 38.0 degrees Celsius \\[°C\\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\\>) 40.0°C. Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the 31-day (Days 0-30) post-primary vaccination period, 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': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the 31-day (Days 0-30) post booster vaccination period', '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': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the primary vaccination period', 'description': 'A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'OG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the booster vaccination period', 'description': 'A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'FG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Synflorix I Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'BG001', 'title': 'Synflorix II Group', 'description': 'Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '1.94', 'groupId': 'BG000'}, {'value': '12.1', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '12.05', 'spread': '1.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 351}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2006-03-24', 'resultsFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2006-03-24', 'lastUpdatePostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-16', 'studyFirstPostDateStruct': {'date': '2006-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Pneumococcal Serotypes', 'timeFrame': 'One month post-dose 2 (Month 3) administration of Synflorix™ vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Pneumococcal Serotypes', 'timeFrame': 'One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs).'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotypes', 'timeFrame': 'One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F 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 and Booster Phases of the study.'}, {'measure': 'Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes', 'timeFrame': 'One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Seropositivity status was defined as the opsonophacocytic activity against pneumococcal serotypes greater than or egual to (≥) the value of 8. The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).This outcome concerns results for the Primary and Booster Phases of the study.'}, {'measure': 'Antibody Concentrations Against Protein D (Anti-PD)', 'timeFrame': 'One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Anti-protein D concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).Seropositivity status was defined as Anti-PD antibody concentrations greater than or equal to (≥) the value of 100 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.'}, {'measure': 'Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Concentrations of antibodies are presented as geometric mean concentrations, expressed as international units per milliliter (IU/mL). Seroprotection status was defined as anti-diphteria and anti-tetanus toxoid antibody concentrations greater than or equal to (≥) the value of 0.1 IU/mL. This outcome concerns results for the Primary and Booster Phases of the study.'}, {'measure': 'Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP)', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix™ vaccine', 'description': 'Concentrations of antibodies are presented as geometric mean concentrations, expressed as micrograms per milliliter (μg/mL). Seroprotection status was defined as anti-polyribosyl ribitol phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) the cut-off values of 0.15 μg/mL and ≥ 1.0 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.'}, {'measure': 'Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Concentrations of antibodies are presented as geometric mean concentrations, expressed as enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity status was defined as anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) the cut-off value of 5 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.'}, {'measure': 'Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Concentrations of antibodies are presented as geometric mean concentrations, expressed as milli international units per milliliter (mIU/mL). Seroprotection status was defined as anti-hepatitis B surface antigen (anti-HBs) antibody concentrations greater than or equal to (≥) the cut-off value of 10 mIU/mL. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.'}, {'measure': 'Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3)', 'timeFrame': 'One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine', 'description': 'Titers of antibodies are presented as geometric mean titers. Seroprotection status was defined as anti-polio types 1, 2 and 3 (Anti-polio 1, 2 and 3) antibody titers greater than or equal to (≥) the value of 8. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.'}, {'measure': 'Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies', 'timeFrame': 'One month after (Month 9) the administration of the booster dose of Synflorix™ vaccine', 'description': 'Booster vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN), defined as the appearance of antibodies in subjects who were seronegative (Pre-booster status S-) (i.e., with antibody concentrations \\< 5 EL.U/mL) just before booster dose, and at least two-fold increase of pre-vaccination antibody concentrations in those who were seropositive (Pre-booster status S+) (i.e., with antibody concentrations ≥ 5 EL.U/mL) just before booster dose.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine', 'description': 'Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\\>) 30 millimeters (mm). Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine', 'description': 'Assessed solicited general symptoms were drowsiness, irritability/fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and fever (rectal temperature higher than \\[≥\\] 38.0 degrees Celsius \\[°C\\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\\>) 40.0°C. Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events', 'timeFrame': 'Within the 31-day (Days 0-30) post-primary vaccination period, 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', 'timeFrame': 'Within the 31-day (Days 0-30) post booster vaccination period', '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', 'timeFrame': 'During the primary vaccination period', 'description': 'A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events', 'timeFrame': 'During the booster vaccination period', 'description': 'A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.'}]}, 'conditionsModule': {'keywords': ['Primary vaccination', 'Pneumococcal disease', 'Safety', 'Booster vaccination', 'Immunogenicity', 'Pneumococcal vaccine', 'Dose comparison'], 'conditions': ['Infections, Streptococcal']}, 'referencesModule': {'availIpds': [{'id': '105539', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '105539', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '105539', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '105539', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '105539', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '105539', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'type': 'BACKGROUND', 'citation': 'Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.'}, {'type': 'BACKGROUND', 'citation': 'Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.'}, {'type': 'BACKGROUND', 'citation': 'Schuerman L et al. Prevention of invasive pneumococcal disease and meningitis with PHiD-CV when used according to a 2+1 schedule. Abstract presented at the Meningitis Research Foundation Conference (MRFC). London, UK, 11-12 November 2009.'}, {'pmid': '20118683', 'type': 'BACKGROUND', 'citation': 'Silfverdal SA, Hogh B, Bergsaker MR, Skerlikova H, Lommel P, Borys D, Schuerman L. Immunogenicity of a 2-dose priming and booster vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine. Pediatr Infect Dis J. 2009 Oct;28(10):e276-82. doi: 10.1097/INF.0b013e3181b48ca3.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)', 'detailedDescription': 'Total anticipated: 300 subjects (150/group). 2-dose group - 10-valent pneumococcal vaccine + DTPa combined vaccine (2, 4, 11 months); Comparator group - 10-valent pneumococcal vaccine (2, 3, 4, 11 months) + DTPa combined vaccine (2, 4, 11 months). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Weeks', 'minimumAge': '8 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.\n* A male or female between, and including, 8 and 16 weeks (56-120 days) of age at the time of the first vaccination.\n* Written informed consent obtained from the parent or guardian of the subject.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* Born after a gestation period of 36 to 42 weeks.\n\nExclusion criteria:\n\n* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) and ending 30 days after the last dose, with exception of BCG vaccination which can be given after the 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule) blood sampling and a minimum of 30 days before the pre-booster dose blood sampling.\n* Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae.\n* History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* History of any neurologic disorders or seizures.\n* Acute disease at the time of enrolment.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination\n* A family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or serious chronic illness.\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.'}, 'identificationModule': {'nctId': 'NCT00307034', 'briefTitle': 'Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "An Open, Randomized, Phase IIIa Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly According to a 2-4-11 Months Vaccination Schedule", 'orgStudyIdInfo': {'id': '105539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2-dose group', 'description': "Subjects receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine at 2-4-11 months of age, co-administered with DTPa-combined vaccine (Infanrix hexa or Infanrix IPV/Hib) at 2-4-11 months of age.", 'interventionNames': ["Biological: GSK Biologicals' 10-valent pneumococcal conjugate vaccine.", 'Biological: Infanrix hexa.', 'Biological: Infanrix-IPV/Hib.']}, {'type': 'EXPERIMENTAL', 'label': 'Comparator group', 'description': "Subjects receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine at 2-3-4-11 months of age, co-administered with DTPa-combined vaccine (Infanrix hexa or Infanrix IPV/Hib) at 2-4-11 months of age.", 'interventionNames': ["Biological: GSK Biologicals' 10-valent pneumococcal conjugate vaccine.", 'Biological: Infanrix hexa.', 'Biological: Infanrix-IPV/Hib.']}], 'interventions': [{'name': "GSK Biologicals' 10-valent pneumococcal conjugate vaccine.", 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).', 'armGroupLabels': ['2-dose group', 'Comparator group']}, {'name': 'Infanrix hexa.', 'type': 'BIOLOGICAL', 'otherNames': ['DTPa-HBV-IPV/Hib'], 'description': 'Intramuscular injection, 3 doses (2-4-11 months of age schedule).', 'armGroupLabels': ['2-dose group', 'Comparator group']}, {'name': 'Infanrix-IPV/Hib.', 'type': 'BIOLOGICAL', 'otherNames': ['DTPa-IPV/Hib'], 'description': 'Intramuscular injection, 3 doses (2-4-11 months of age schedule).', 'armGroupLabels': ['2-dose group', 'Comparator group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '5125', 'city': 'Morvik', 'country': 'Norway', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.46985, 'lon': 5.27504}}, {'zip': '0130', 'city': 'Oslo', 'country': 'Norway', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '026 01', 'city': 'Dolný Kubín', 'country': 'Slovakia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.20983, 'lon': 19.30341}}, {'zip': '034 01', 'city': 'Ružomberok', 'country': 'Slovakia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.0748, 'lon': 19.30751}}, {'zip': 'SE-416 73', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'SE-702 11', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': 'SE-901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}