Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT01641133
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™
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': 'C547294', 'term': 'PHiD-CV vaccine'}, {'id': 'C538862', 'term': '13-valent pneumococcal 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 local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 85, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 88, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 86, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pain (primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Redness (primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Swelling (primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pain (booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Redness (booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Swelling (booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drowsiness (primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Irritability (primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Loss of appetite (primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fever (primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drowsiness (booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Irritability (booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Loss of appetite (booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fever (booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis (primary phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis (booster phase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'Any AEs Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Any AEs Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'General AEs Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'General AEs Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Local AEs Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Local AEs Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 31-day (Day 0-Day 30) after any dose of primary vaccination', 'description': 'The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'Any Pain Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each primary dose', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-booster vaccination period', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'Any Drowsiness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Fever Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Any Drowsiness Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Fever Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each primary dose', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Related Drowsiness', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Related Irritability', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Loss of appetite', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Loss of appetite', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Fever', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-booster vaccination period', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'Any symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Any Grade 3 symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'General symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 general symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Local symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 local symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Days 0-30) post-booster vaccination period', 'description': 'The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited AEs - Primary Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Days 0-30) post-primary vaccination period', 'description': 'An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited AEs - Booster Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Days 0-30) post-booster vaccination period', 'description': 'An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first vaccination (Month 0) up to study end (11-14 months)', 'description': 'SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.'}, {'type': 'SECONDARY', 'title': 'Antibody Concentrations Against Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'Anti-1 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000', 'lowerLimit': '2.32', 'upperLimit': '3.24'}, {'value': '3.12', 'groupId': 'OG001', 'lowerLimit': '2.63', 'upperLimit': '3.7'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '3.44', 'upperLimit': '4.65'}]}]}, {'title': 'Anti-1 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.4'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.64'}, {'value': '0.62', 'groupId': 'OG002', 'lowerLimit': '0.52', 'upperLimit': '0.74'}]}]}, {'title': 'Anti-1 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.61', 'groupId': 'OG000', 'lowerLimit': '3.93', 'upperLimit': '5.41'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '4.9'}, {'value': '5.22', 'groupId': 'OG002', 'lowerLimit': '4.52', 'upperLimit': '6.03'}]}]}, {'title': 'Anti-3 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.08'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '0.97'}, {'value': '2.48', 'groupId': 'OG002', 'lowerLimit': '2.21', 'upperLimit': '2.78'}]}]}, {'title': 'Anti-3 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.12'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.25'}, {'value': '0.37', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.44'}]}]}, {'title': 'Anti-3 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.14'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.25'}, {'value': '0.33', 'groupId': 'OG002', 'lowerLimit': '0.27', 'upperLimit': '0.41'}]}]}, {'title': 'Anti-4 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.54', 'groupId': 'OG000', 'lowerLimit': '3.12', 'upperLimit': '4.02'}, {'value': '2.73', 'groupId': 'OG001', 'lowerLimit': '2.22', 'upperLimit': '3.34'}, {'value': '2.74', 'groupId': 'OG002', 'lowerLimit': '2.34', 'upperLimit': '3.21'}]}]}, {'title': 'Anti-4 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.66'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.46', 'upperLimit': '0.68'}, {'value': '0.39', 'groupId': 'OG002', 'lowerLimit': '0.32', 'upperLimit': '0.48'}]}]}, {'title': 'Anti-4 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.76', 'groupId': 'OG000', 'lowerLimit': '5.87', 'upperLimit': '7.79'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '3.94', 'upperLimit': '5.6'}, {'value': '8.77', 'groupId': 'OG002', 'lowerLimit': '7.26', 'upperLimit': '10.59'}]}]}, {'title': 'Anti-5 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.55', 'groupId': 'OG000', 'lowerLimit': '3.95', 'upperLimit': '5.24'}, {'value': '2.59', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.18'}, {'value': '4.89', 'groupId': 'OG002', 'lowerLimit': '4.11', 'upperLimit': '5.8'}]}]}, {'title': 'Anti-5 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '1.17'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '0.92'}, {'value': '1.05', 'groupId': 'OG002', 'lowerLimit': '0.88', 'upperLimit': '1.25'}]}]}, {'title': 'Anti-5 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '7.08', 'upperLimit': '9.77'}, {'value': '5.27', 'groupId': 'OG001', 'lowerLimit': '4.33', 'upperLimit': '6.41'}, {'value': '6.15', 'groupId': 'OG002', 'lowerLimit': '5.17', 'upperLimit': '7.32'}]}]}, {'title': 'Anti-6A Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.29'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.45'}, {'value': '3.35', 'groupId': 'OG002', 'lowerLimit': '2.53', 'upperLimit': '4.42'}]}]}, {'title': 'Anti-6A Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.31'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.36'}, {'value': '0.67', 'groupId': 'OG002', 'lowerLimit': '0.55', 'upperLimit': '0.82'}]}]}, {'title': 'Anti-6A Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.72'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '1.24'}, {'value': '1.97', 'groupId': 'OG002', 'lowerLimit': '1.52', 'upperLimit': '2.55'}]}]}, {'title': 'Anti-6B Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '1.18'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.27'}, {'value': '0.38', 'groupId': 'OG002', 'lowerLimit': '0.29', 'upperLimit': '0.51'}]}]}, {'title': 'Anti-6B Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.59'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.37'}, {'value': '0.24', 'groupId': 'OG002', 'lowerLimit': '0.19', 'upperLimit': '0.3'}]}]}, {'title': 'Anti-6B Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.53', 'groupId': 'OG000', 'lowerLimit': '2.96', 'upperLimit': '4.2'}, {'value': '1.92', 'groupId': 'OG001', 'lowerLimit': '1.53', 'upperLimit': '2.42'}, {'value': '3.03', 'groupId': 'OG002', 'lowerLimit': '2.56', 'upperLimit': '3.57'}]}]}, {'title': 'Anti-7F Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.36', 'groupId': 'OG000', 'lowerLimit': '2.96', 'upperLimit': '3.81'}, {'value': '2.74', 'groupId': 'OG001', 'lowerLimit': '2.35', 'upperLimit': '3.19'}, {'value': '4.83', 'groupId': 'OG002', 'lowerLimit': '4.32', 'upperLimit': '5.4'}]}]}, {'title': 'Anti-7F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.37'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.84', 'upperLimit': '1.19'}, {'value': '1.24', 'groupId': 'OG002', 'lowerLimit': '1.07', 'upperLimit': '1.45'}]}]}, {'title': 'Anti-7F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.63', 'groupId': 'OG000', 'lowerLimit': '6.69', 'upperLimit': '8.71'}, {'value': '5.07', 'groupId': 'OG001', 'lowerLimit': '4.38', 'upperLimit': '5.87'}, {'value': '5.83', 'groupId': 'OG002', 'lowerLimit': '5.07', 'upperLimit': '6.69'}]}]}, {'title': 'Anti-9V Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.67', 'groupId': 'OG000', 'lowerLimit': '2.28', 'upperLimit': '3.13'}, {'value': '1.34', 'groupId': 'OG001', 'lowerLimit': '1.12', 'upperLimit': '1.59'}, {'value': '2.96', 'groupId': 'OG002', 'lowerLimit': '2.49', 'upperLimit': '3.51'}]}]}, {'title': 'Anti-9V Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '1.04'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.56'}, {'value': '0.53', 'groupId': 'OG002', 'lowerLimit': '0.45', 'upperLimit': '0.62'}]}]}, {'title': 'Anti-9V Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.04', 'groupId': 'OG000', 'lowerLimit': '5.99', 'upperLimit': '8.26'}, {'value': '2.48', 'groupId': 'OG001', 'lowerLimit': '2.11', 'upperLimit': '2.92'}, {'value': '2.84', 'groupId': 'OG002', 'lowerLimit': '2.42', 'upperLimit': '3.34'}]}]}, {'title': 'Anti-14 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.74', 'groupId': 'OG000', 'lowerLimit': '3.87', 'upperLimit': '5.81'}, {'value': '3.45', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': '4.25'}, {'value': '4.99', 'groupId': 'OG002', 'lowerLimit': '3.89', 'upperLimit': '6.42'}]}]}, {'title': 'Anti-14 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.49'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '1.29'}, {'value': '1.78', 'groupId': 'OG002', 'lowerLimit': '1.45', 'upperLimit': '2.19'}]}]}, {'title': 'Anti-14 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.04', 'groupId': 'OG000', 'lowerLimit': '8.44', 'upperLimit': '11.95'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '6.68', 'upperLimit': '9.83'}, {'value': '7.62', 'groupId': 'OG002', 'lowerLimit': '6.3', 'upperLimit': '9.22'}]}]}, {'title': 'Anti-18C Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '2.54', 'upperLimit': '4.28'}, {'value': '3.22', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '4.14'}, {'value': '3.24', 'groupId': 'OG002', 'lowerLimit': '2.62', 'upperLimit': '4'}]}]}, {'title': 'Anti-18C Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '0.98'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.53', 'upperLimit': '0.81'}, {'value': '0.56', 'groupId': 'OG002', 'lowerLimit': '0.47', 'upperLimit': '0.66'}]}]}, {'title': 'Anti-18C Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.18', 'groupId': 'OG000', 'lowerLimit': '20.92', 'upperLimit': '30.31'}, {'value': '19.39', 'groupId': 'OG001', 'lowerLimit': '15.36', 'upperLimit': '24.48'}, {'value': '19.27', 'groupId': 'OG002', 'lowerLimit': '15.57', 'upperLimit': '23.85'}]}]}, {'title': 'Anti-19A Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.32'}, {'value': '0.72', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '0.87'}, {'value': '2.43', 'groupId': 'OG002', 'lowerLimit': '1.91', 'upperLimit': '3.1'}]}]}, {'title': 'Anti-19A Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.25'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.27', 'upperLimit': '0.5'}, {'value': '0.34', 'groupId': 'OG002', 'lowerLimit': '0.25', 'upperLimit': '0.46'}]}]}, {'title': 'Anti-19A Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.23'}, {'value': '1.67', 'groupId': 'OG001', 'lowerLimit': '1.17', 'upperLimit': '2.38'}, {'value': '2.17', 'groupId': 'OG002', 'lowerLimit': '1.64', 'upperLimit': '2.86'}]}]}, {'title': 'Anti-19F Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.62', 'groupId': 'OG000', 'lowerLimit': '3.76', 'upperLimit': '5.69'}, {'value': '5.67', 'groupId': 'OG001', 'lowerLimit': '4.63', 'upperLimit': '6.95'}, {'value': '4.17', 'groupId': 'OG002', 'lowerLimit': '3.69', 'upperLimit': '4.72'}]}]}, {'title': 'Anti-19F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.48'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '1.14', 'upperLimit': '1.71'}, {'value': '0.53', 'groupId': 'OG002', 'lowerLimit': '0.43', 'upperLimit': '0.65'}]}]}, {'title': 'Anti-19F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.43', 'groupId': 'OG000', 'lowerLimit': '12.02', 'upperLimit': '17.32'}, {'value': '13.57', 'groupId': 'OG001', 'lowerLimit': '11.29', 'upperLimit': '16.32'}, {'value': '13.81', 'groupId': 'OG002', 'lowerLimit': '11.63', 'upperLimit': '16.4'}]}]}, {'title': 'Anti-23F Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.43', 'groupId': 'OG000', 'lowerLimit': '1.11', 'upperLimit': '1.85'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.68'}, {'value': '1.74', 'groupId': 'OG002', 'lowerLimit': '1.28', 'upperLimit': '2.37'}]}]}, {'title': 'Anti-23F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.67'}, {'value': '0.24', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '0.3'}, {'value': '0.36', 'groupId': 'OG002', 'lowerLimit': '0.29', 'upperLimit': '0.45'}]}]}, {'title': 'Anti-23F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.16', 'groupId': 'OG000', 'lowerLimit': '3.23', 'upperLimit': '5.36'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '1.42', 'upperLimit': '2.18'}, {'value': '2.76', 'groupId': 'OG002', 'lowerLimit': '2.29', 'upperLimit': '3.34'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)', 'description': 'Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Antibodies Against Protein D (Anti-PD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'Anti-PD Month 3 (N=45,50,37)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2025.1', 'groupId': 'OG000', 'lowerLimit': '1601', 'upperLimit': '2561.4'}, {'value': '117.2', 'groupId': 'OG001', 'lowerLimit': '90.4', 'upperLimit': '152.1'}, {'value': '143.2', 'groupId': 'OG002', 'lowerLimit': '106.8', 'upperLimit': '192.1'}]}]}, {'title': 'Anti-PD Month 11 (N=45,42,37)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3658.5', 'groupId': 'OG000', 'lowerLimit': '2741.1', 'upperLimit': '4882.8'}, {'value': '791', 'groupId': 'OG001', 'lowerLimit': '576.2', 'upperLimit': '1085.8'}, {'value': '219.7', 'groupId': 'OG002', 'lowerLimit': '156.2', 'upperLimit': '309.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)', 'description': 'Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'OG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'classes': [{'title': 'OPA-1 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '87.9'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '35.6', 'upperLimit': '74.5'}, {'value': '96.4', 'groupId': 'OG002', 'lowerLimit': '69.4', 'upperLimit': '134.1'}]}]}, {'title': 'OPA-1 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '13.2'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '10.6'}, {'value': '9.4', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '11.6'}]}]}, {'title': 'OPA-1 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '311.6', 'groupId': 'OG000', 'lowerLimit': '224.6', 'upperLimit': '432.5'}, {'value': '139.3', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '198.8'}, {'value': '240.3', 'groupId': 'OG002', 'lowerLimit': '186.5', 'upperLimit': '309.7'}]}]}, {'title': 'OPA-3 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '6.1'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '39.5', 'upperLimit': '64.6'}, {'value': '190.7', 'groupId': 'OG002', 'lowerLimit': '164.2', 'upperLimit': '221.6'}]}]}, {'title': 'OPA-3 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '25.6'}, {'value': '33.2', 'groupId': 'OG001', 'lowerLimit': '24.7', 'upperLimit': '44.6'}, {'value': '41.3', 'groupId': 'OG002', 'lowerLimit': '29.4', 'upperLimit': '58.0'}]}]}, {'title': 'OPA-3 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '14.6'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '29.9'}, {'value': '29.7', 'groupId': 'OG002', 'lowerLimit': '22.1', 'upperLimit': '39.8'}]}]}, {'title': 'OPA-4 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1327.9', 'groupId': 'OG000', 'lowerLimit': '1127.4', 'upperLimit': '1563.9'}, {'value': '812.1', 'groupId': 'OG001', 'lowerLimit': '623.2', 'upperLimit': '1058.2'}, {'value': '1391.5', 'groupId': 'OG002', 'lowerLimit': '1135.4', 'upperLimit': '1705.4'}]}]}, {'title': 'OPA-4 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '128.1', 'groupId': 'OG000', 'lowerLimit': '75.5', 'upperLimit': '217.5'}, {'value': '123.5', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '203.6'}, {'value': '91.4', 'groupId': 'OG002', 'lowerLimit': '56.4', 'upperLimit': '148.1'}]}]}, {'title': 'OPA-4 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2729.6', 'groupId': 'OG000', 'lowerLimit': '2191.8', 'upperLimit': '3399.3'}, {'value': '1583.4', 'groupId': 'OG001', 'lowerLimit': '1297.1', 'upperLimit': '1932.9'}, {'value': '3033.2', 'groupId': 'OG002', 'lowerLimit': '2333.0', 'upperLimit': '3943.5'}]}]}, {'title': 'OPA-5 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '335.9', 'groupId': 'OG000', 'lowerLimit': '258.5', 'upperLimit': '436.5'}, {'value': '132.0', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '189.8'}, {'value': '250.2', 'groupId': 'OG002', 'lowerLimit': '177.3', 'upperLimit': '353.1'}]}]}, {'title': 'OPA-5 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '47.0', 'upperLimit': '100.3'}, {'value': '29.3', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '40.3'}, {'value': '37.3', 'groupId': 'OG002', 'lowerLimit': '26.5', 'upperLimit': '52.5'}]}]}, {'title': 'OPA-5 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '669.2', 'groupId': 'OG000', 'lowerLimit': '504.7', 'upperLimit': '887.3'}, {'value': '266.2', 'groupId': 'OG001', 'lowerLimit': '198.0', 'upperLimit': '357.8'}, {'value': '379.4', 'groupId': 'OG002', 'lowerLimit': '280.2', 'upperLimit': '513.8'}]}]}, {'title': 'OPA-6A Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000', 'lowerLimit': '38.6', 'upperLimit': '94.6'}, {'value': '91.9', 'groupId': 'OG001', 'lowerLimit': '59.5', 'upperLimit': '142.1'}, {'value': '1185.5', 'groupId': 'OG002', 'lowerLimit': '781.5', 'upperLimit': '1798.2'}]}]}, {'title': 'OPA-6A Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG000', 'lowerLimit': '56.2', 'upperLimit': '164.3'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '41.7', 'upperLimit': '129.5'}, {'value': '112.1', 'groupId': 'OG002', 'lowerLimit': '68.3', 'upperLimit': '183.9'}]}]}, {'title': 'OPA-6A Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '480.2', 'groupId': 'OG000', 'lowerLimit': '315.8', 'upperLimit': '730.1'}, {'value': '216.8', 'groupId': 'OG001', 'lowerLimit': '120.5', 'upperLimit': '390.2'}, {'value': '363.5', 'groupId': 'OG002', 'lowerLimit': '227.8', 'upperLimit': '580.1'}]}]}, {'title': 'OPA-6B Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '603.6', 'groupId': 'OG000', 'lowerLimit': '393.5', 'upperLimit': '925.8'}, {'value': '107.4', 'groupId': 'OG001', 'lowerLimit': '66.4', 'upperLimit': '173.6'}, {'value': '331.6', 'groupId': 'OG002', 'lowerLimit': '192.2', 'upperLimit': '572.0'}]}]}, {'title': 'OPA-6B Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '182.8', 'groupId': 'OG000', 'lowerLimit': '100.7', 'upperLimit': '331.6'}, {'value': '131.3', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '243.7'}, {'value': '60.1', 'groupId': 'OG002', 'lowerLimit': '35.1', 'upperLimit': '102.9'}]}]}, {'title': 'OPA-6B Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1868.1', 'groupId': 'OG000', 'lowerLimit': '1373.4', 'upperLimit': '2540.8'}, {'value': '958.5', 'groupId': 'OG001', 'lowerLimit': '654.5', 'upperLimit': '1403.7'}, {'value': '1202.2', 'groupId': 'OG002', 'lowerLimit': '946.7', 'upperLimit': '1526.7'}]}]}, {'title': 'OPA-7F Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2595.4', 'groupId': 'OG000', 'lowerLimit': '2133.8', 'upperLimit': '3156.9'}, {'value': '1702.1', 'groupId': 'OG001', 'lowerLimit': '1330.8', 'upperLimit': '2176.8'}, {'value': '4654.8', 'groupId': 'OG002', 'lowerLimit': '3739.1', 'upperLimit': '5794.8'}]}]}, {'title': 'OPA-7F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '654.5', 'groupId': 'OG000', 'lowerLimit': '430.9', 'upperLimit': '994.1'}, {'value': '676.6', 'groupId': 'OG001', 'lowerLimit': '499.3', 'upperLimit': '916.8'}, {'value': '858.3', 'groupId': 'OG002', 'lowerLimit': '582.1', 'upperLimit': '1265.4'}]}]}, {'title': 'OPA-7F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3557.9', 'groupId': 'OG000', 'lowerLimit': '2936.0', 'upperLimit': '4311.6'}, {'value': '2337.9', 'groupId': 'OG001', 'lowerLimit': '1901.8', 'upperLimit': '2874.2'}, {'value': '2178.5', 'groupId': 'OG002', 'lowerLimit': '1671.3', 'upperLimit': '2839.7'}]}]}, {'title': 'OPA-9V Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1904.8', 'groupId': 'OG000', 'lowerLimit': '1457.9', 'upperLimit': '2488.7'}, {'value': '1141.6', 'groupId': 'OG001', 'lowerLimit': '809.2', 'upperLimit': '1610.7'}, {'value': '2916.6', 'groupId': 'OG002', 'lowerLimit': '2422.6', 'upperLimit': '3511.3'}]}]}, {'title': 'OPA-9V Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '424.8', 'groupId': 'OG000', 'lowerLimit': '295.2', 'upperLimit': '611.1'}, {'value': '441.3', 'groupId': 'OG001', 'lowerLimit': '302.3', 'upperLimit': '644.2'}, {'value': '353.9', 'groupId': 'OG002', 'lowerLimit': '235.9', 'upperLimit': '531.0'}]}]}, {'title': 'OPA-9V Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5130.2', 'groupId': 'OG000', 'lowerLimit': '4255.2', 'upperLimit': '6185.2'}, {'value': '2391.0', 'groupId': 'OG001', 'lowerLimit': '1944.4', 'upperLimit': '2940.3'}, {'value': '1720.7', 'groupId': 'OG002', 'lowerLimit': '1407.4', 'upperLimit': '2103.8'}]}]}, {'title': 'OPA-14 Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1497.1', 'groupId': 'OG000', 'lowerLimit': '1102.1', 'upperLimit': '2033.6'}, {'value': '924.2', 'groupId': 'OG001', 'lowerLimit': '624.0', 'upperLimit': '1368.8'}, {'value': '1391.5', 'groupId': 'OG002', 'lowerLimit': '807.6', 'upperLimit': '2397.5'}]}]}, {'title': 'OPA-14 Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '303.4', 'groupId': 'OG000', 'lowerLimit': '181.6', 'upperLimit': '506.9'}, {'value': '270.2', 'groupId': 'OG001', 'lowerLimit': '165.2', 'upperLimit': '442.0'}, {'value': '342.3', 'groupId': 'OG002', 'lowerLimit': '217.3', 'upperLimit': '539.0'}]}]}, {'title': 'OPA-14 Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3132.1', 'groupId': 'OG000', 'lowerLimit': '2355.4', 'upperLimit': '4164.8'}, {'value': '2043.1', 'groupId': 'OG001', 'lowerLimit': '1539.0', 'upperLimit': '2712.3'}, {'value': '1413.9', 'groupId': 'OG002', 'lowerLimit': '1103.9', 'upperLimit': '1811.0'}]}]}, {'title': 'OPA-18C Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '965.3', 'groupId': 'OG000', 'lowerLimit': '636.3', 'upperLimit': '1464.6'}, {'value': '685.5', 'groupId': 'OG001', 'lowerLimit': '473.4', 'upperLimit': '992.7'}, {'value': '1114.7', 'groupId': 'OG002', 'lowerLimit': '835.1', 'upperLimit': '1488.1'}]}]}, {'title': 'OPA-18C Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '116.5', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '197.8'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '107.5'}, {'value': '61.8', 'groupId': 'OG002', 'lowerLimit': '39.5', 'upperLimit': '96.8'}]}]}, {'title': 'OPA-18C Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6271.0', 'groupId': 'OG000', 'lowerLimit': '5032.6', 'upperLimit': '7814.2'}, {'value': '4731.5', 'groupId': 'OG001', 'lowerLimit': '3739.3', 'upperLimit': '5987.0'}, {'value': '4358.6', 'groupId': 'OG002', 'lowerLimit': '3271.4', 'upperLimit': '5807.2'}]}]}, {'title': 'OPA-19A Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000', 'lowerLimit': '44.3', 'upperLimit': '163.9'}, {'value': '173.4', 'groupId': 'OG001', 'lowerLimit': '111.5', 'upperLimit': '269.8'}, {'value': '677.2', 'groupId': 'OG002', 'lowerLimit': '425.5', 'upperLimit': '1077.8'}]}]}, {'title': 'OPA-19A Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '69.3'}, {'value': '71.7', 'groupId': 'OG001', 'lowerLimit': '39.6', 'upperLimit': '129.9'}, {'value': '69.5', 'groupId': 'OG002', 'lowerLimit': '33.7', 'upperLimit': '143.6'}]}]}, {'title': 'OPA-19A Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '748.8', 'groupId': 'OG000', 'lowerLimit': '446.0', 'upperLimit': '1257.3'}, {'value': '642.2', 'groupId': 'OG001', 'lowerLimit': '401.2', 'upperLimit': '1028.0'}, {'value': '1061.6', 'groupId': 'OG002', 'lowerLimit': '663.1', 'upperLimit': '1699.6'}]}]}, {'title': 'OPA-19F Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1306.1', 'groupId': 'OG000', 'lowerLimit': '1016.4', 'upperLimit': '1678.3'}, {'value': '1492.8', 'groupId': 'OG001', 'lowerLimit': '1157.3', 'upperLimit': '1925.6'}, {'value': '842.3', 'groupId': 'OG002', 'lowerLimit': '706.0', 'upperLimit': '1005.0'}]}]}, {'title': 'OPA-19F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127.6', 'groupId': 'OG000', 'lowerLimit': '82.7', 'upperLimit': '196.9'}, {'value': '158.8', 'groupId': 'OG001', 'lowerLimit': '106.3', 'upperLimit': '237.2'}, {'value': '42.0', 'groupId': 'OG002', 'lowerLimit': '28.6', 'upperLimit': '61.8'}]}]}, {'title': 'OPA-19F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2900.7', 'groupId': 'OG000', 'lowerLimit': '2180.8', 'upperLimit': '3858.1'}, {'value': '2749.9', 'groupId': 'OG001', 'lowerLimit': '2133.7', 'upperLimit': '3544.1'}, {'value': '3696.9', 'groupId': 'OG002', 'lowerLimit': '2753.6', 'upperLimit': '4963.1'}]}]}, {'title': 'OPA-23F Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '633.3', 'groupId': 'OG000', 'lowerLimit': '405.4', 'upperLimit': '989.3'}, {'value': '143.9', 'groupId': 'OG001', 'lowerLimit': '94.3', 'upperLimit': '219.4'}, {'value': '1089.4', 'groupId': 'OG002', 'lowerLimit': '735.9', 'upperLimit': '1612.8'}]}]}, {'title': 'OPA-23F Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '234.9', 'groupId': 'OG000', 'lowerLimit': '134.8', 'upperLimit': '409.3'}, {'value': '199.1', 'groupId': 'OG001', 'lowerLimit': '105.6', 'upperLimit': '375.3'}, {'value': '164.3', 'groupId': 'OG002', 'lowerLimit': '91.8', 'upperLimit': '294.2'}]}]}, {'title': 'OPA-23F Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1500.7', 'groupId': 'OG000', 'lowerLimit': '1023.4', 'upperLimit': '2200.6'}, {'value': '1005.7', 'groupId': 'OG001', 'lowerLimit': '653.4', 'upperLimit': '1548.0'}, {'value': '1097.8', 'groupId': 'OG002', 'lowerLimit': '774.6', 'upperLimit': '1555.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)', 'description': 'The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available. OPA testing was performed on a random subset of 50% per group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'FG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'FG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '457 subjects were enrolled in the study. Of these, 5 subjects were not included in the Total Vaccinated Cohort, as the study vaccine was not administered. In addition, 157 subjects enrolled at one center were excluded from analysis because of GCP deficiencies, and 1 subject from another center because of invalid Informed Consent form.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '294', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'BG001', 'title': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'BG002', 'title': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '7.4', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '7.4', 'spread': '1.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 457}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2013-08-22', 'completionDateStruct': {'date': '2014-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2012-07-12', 'dispFirstSubmitQcDate': '2013-08-22', 'resultsFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2012-07-12', 'dispFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-09', 'studyFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period', 'timeFrame': 'Within 31-day (Day 0-Day 30) after any dose of primary vaccination', 'description': 'The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each primary dose', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period', 'timeFrame': 'During the 4-day (Days 0-3) post-booster vaccination period', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period following each primary dose', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period', 'timeFrame': 'During the 4-day (Days 0-3) post-booster vaccination period', 'description': 'Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period', 'timeFrame': 'During the 31-day (Days 0-30) post-booster vaccination period', 'description': 'The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.'}, {'measure': 'Number of Subjects With Unsolicited AEs - Primary Period', 'timeFrame': 'During the 31-day (Days 0-30) post-primary vaccination period', 'description': 'An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Unsolicited AEs - Booster Period', 'timeFrame': 'During the 31-day (Days 0-30) post-booster vaccination period', 'description': 'An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From first vaccination (Month 0) up to study end (11-14 months)', 'description': 'SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Antibody Concentrations Against Pneumococcal Serotypes', 'timeFrame': 'At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)', 'description': 'Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.'}, {'measure': 'Concentrations of Antibodies Against Protein D (Anti-PD)', 'timeFrame': 'At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)', 'description': 'Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.'}, {'measure': 'Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes', 'timeFrame': 'At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)', 'description': 'The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F.'}]}, 'conditionsModule': {'keywords': ['pneumococcal conjugate vaccine', 'Synflorix', 'Prevnar 13', 'Pneumococcal diseases'], 'conditions': ['Infections, Streptococcal', 'Streptococcus Pneumoniae Vaccines']}, 'referencesModule': {'references': [{'pmid': '33297773', 'type': 'BACKGROUND', 'citation': 'de Los Santos AM, Rodriguez-Weber MA, Sanchez-Marquez P, Traskine M, Carreno-Manjarrez R, Cervantes-Apolinar MY, Strezova A, Ruiz-Guinazu J, Ortega-Barria E, Borys D. Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine. Expert Rev Vaccines. 2020 Nov;19(11):995-1010. doi: 10.1080/14760584.2020.1843431.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.', 'detailedDescription': 'This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \\[LAR(s)\\] can and will comply with the requirements of the protocol.\n* A male or female between, and including, 6-12 weeks of age at the time of the first vaccination.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Born after a gestation period of at least 36 weeks.\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.\n* Major congenital defects or serious chronic illness.\n* History of any seizures or progressive neurological disease.\n* Administration of immunoglobulins and/or blood products since birth or planned use during the study.\n* Acute disease and/or fever at the time of enrolment.\n* Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.'}, 'identificationModule': {'nctId': 'NCT01641133', 'briefTitle': 'Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Two-dose Primary Vaccination With Either GSK Biologicals' 10-valent Pneumococcal Vaccine (Synflorix™) or Pfizer's Prevenar 13™ or Both Vaccines Followed by a Booster Dose of Synflorix™", 'orgStudyIdInfo': {'id': '115992'}, 'secondaryIdInfos': [{'id': '2013-003479-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Synflorix Group', 'description': 'Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.', 'interventionNames': ['Biological: Synflorix (3-Dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Prevnar 1 Group', 'description': 'Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.', 'interventionNames': ['Biological: Synflorix (2-Dose)', 'Biological: Prevenar 13 (Single Dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Prevnar 2 Group', 'description': 'Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.', 'interventionNames': ['Biological: Synflorix (Single Dose)', 'Biological: Prevenar 13 (2-Dose)']}], 'interventions': [{'name': 'Synflorix (3-Dose)', 'type': 'BIOLOGICAL', 'description': '3 doses administered intramuscularly', 'armGroupLabels': ['Synflorix Group']}, {'name': 'Synflorix (2-Dose)', 'type': 'BIOLOGICAL', 'description': '2 doses administered intramuscularly', 'armGroupLabels': ['Prevnar 1 Group']}, {'name': 'Synflorix (Single Dose)', 'type': 'BIOLOGICAL', 'description': '1 dose administered intramuscularly', 'armGroupLabels': ['Prevnar 2 Group']}, {'name': 'Prevenar 13 (Single Dose)', 'type': 'BIOLOGICAL', 'description': '1 dose administered intramuscularly', 'armGroupLabels': ['Prevnar 1 Group']}, {'name': 'Prevenar 13 (2-Dose)', 'type': 'BIOLOGICAL', 'description': '2 doses administered intramuscularly', 'armGroupLabels': ['Prevnar 2 Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62210', 'city': 'Cuernavaca', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '04530', 'city': 'México', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=20769', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)', 'ipdSharing': 'YES', 'description': 'IPD for this study is available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}