Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-02 @ 3:34 AM
Study NCT ID:
NCT00356369
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2006-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lebanon']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, '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': 'Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination.', 'description': 'The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.', 'eventGroups': [{'id': 'EG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.', 'otherNumAtRisk': 374, 'deathsNumAtRisk': 374, 'otherNumAffected': 186, 'seriousNumAtRisk': 374, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 53, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Any Pain', 'notes': 'This solicited local symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Any Redness', 'notes': 'This solicited local symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Any Swelling', 'notes': 'This solicited local symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Any Fatigue', 'notes': 'This solicited general symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Any Headache', 'notes': 'This solicited general symptom was only collected from subjects with their symptom sheets completed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '86.9'}, {'value': '69.7', 'groupId': 'OG001', 'lowerLimit': '59.6', 'upperLimit': '78.5'}]}]}, {'title': 'rSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '91.4', 'upperLimit': '96.7'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '83.2', 'upperLimit': '95'}]}]}, {'title': 'rSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '98.1'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '84.9', 'upperLimit': '96.2'}]}]}, {'title': 'rSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '95.5'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '91'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % for rSBA-MenA antibodies', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13', 'ciLowerLimit': '3.52', 'ciUpperLimit': '23.5', 'groupDescription': 'To evaluate the non-inferiority of the vaccine response\\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was greater than (\\>) -15%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % for rSBA-MenC antibodies', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.18', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '11.36', 'groupDescription': 'To evaluate the non-inferiority of the vaccine response\\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in%for rSBA-MenW-135 antibody', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.58', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '11.49', 'groupDescription': 'To evaluate the non-inferiority of the vaccine response\\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % for rSBA-MenY antibodies', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.05', 'ciLowerLimit': '1.72', 'ciUpperLimit': '16.17', 'groupDescription': 'To evaluate the non-inferiority of the vaccine response\\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.'}], 'paramType': 'NUMBER', 'timeFrame': 'One month post vaccination', 'description': 'Response to vaccine antigen was defined as: for initially seronegative subjects \\[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'PRIMARY', 'title': 'Occurrence of Any Grade 3 Systemic Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Any Grade 3 unsolicited', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 solicited general', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 solicited local', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % Grade 3 general symptoms', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '-1.64', 'ciUpperLimit': '3.09', 'groupDescription': 'To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\\>) 50 millimeters (mm).\n\nGeneral symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \\>39.5 °C.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PRE) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA (PI [M1]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA (PRE) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '273', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA (PI [M1]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PRE) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M1]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PRE) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M1]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PRE) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M1]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PRE) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M1]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '338', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PRE) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '306', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M1]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PRE) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M1]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'rSBA Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '330.7', 'groupId': 'OG000', 'lowerLimit': '285.8', 'upperLimit': '382.7'}, {'value': '227.8', 'groupId': 'OG001', 'lowerLimit': '162.1', 'upperLimit': '320.2'}]}]}, {'title': 'rSBA-MenA (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4944.6', 'groupId': 'OG000', 'lowerLimit': '4451.5', 'upperLimit': '5492.5'}, {'value': '2190.1', 'groupId': 'OG001', 'lowerLimit': '1857.5', 'upperLimit': '2582.2'}]}]}, {'title': 'rSBA-MenC (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000', 'lowerLimit': '68.5', 'upperLimit': '103.4'}, {'value': '114.1', 'groupId': 'OG001', 'lowerLimit': '80.3', 'upperLimit': '162'}]}]}, {'title': 'rSBA-MenC (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10073.7', 'groupId': 'OG000', 'lowerLimit': '8699.9', 'upperLimit': '11664.5'}, {'value': '6545.6', 'groupId': 'OG001', 'lowerLimit': '5047.5', 'upperLimit': '8488.4'}]}]}, {'title': 'rSBA-MenW-135 (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '74.6', 'upperLimit': '116'}, {'value': '115.3', 'groupId': 'OG001', 'lowerLimit': '81.6', 'upperLimit': '162.9'}]}]}, {'title': 'rSBA-MenW-135 (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8576.5', 'groupId': 'OG000', 'lowerLimit': '7614.9', 'upperLimit': '9659.5'}, {'value': '2969.5', 'groupId': 'OG001', 'lowerLimit': '2439.4', 'upperLimit': '3614.9'}]}]}, {'title': 'rSBA-MenY (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000', 'lowerLimit': '261.2', 'upperLimit': '367.9'}, {'value': '282.8', 'groupId': 'OG001', 'lowerLimit': '209.9', 'upperLimit': '380.8'}]}]}, {'title': 'rSBA-MenY (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10315.2', 'groupId': 'OG000', 'lowerLimit': '9317.1', 'upperLimit': '11420.2'}, {'value': '4573.7', 'groupId': 'OG001', 'lowerLimit': '3863.9', 'upperLimit': '5413.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-PSA (PRE) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA (PI [M1]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA (PRE) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA (PI [M1]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PRE) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PI [M1]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PRE) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PI [M1]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '333', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PRE) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PI [M1]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PRE) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PI [M1]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '314', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PRE) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PI [M1]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '338', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PRE) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PI [M1]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '328', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Concentration of Anti-PS Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-PSA (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.7'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.3'}]}]}, {'title': 'Anti-PSA (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '107.3', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '124.1'}, {'value': '53.6', 'groupId': 'OG001', 'lowerLimit': '41.9', 'upperLimit': '68.5'}]}]}, {'title': 'Anti-PSC (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Anti-PSC (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '27.2'}, {'value': '43.9', 'groupId': 'OG001', 'lowerLimit': '35.6', 'upperLimit': '54.1'}]}]}, {'title': 'Anti-PSW-135 (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.2'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.3'}]}]}, {'title': 'Anti-PSW-135 (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '21.8'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '20.7'}]}]}, {'title': 'Anti-PSY (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.3'}]}]}, {'title': 'Anti-PSY (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '19.9', 'upperLimit': '26.9'}, {'value': '23.6', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '30.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-TT (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Anti-TT (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Concentration of Anti-TT Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-TT (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.43'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.39'}]}]}, {'title': 'Anti-TT (PI [M1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.01', 'groupId': 'OG000', 'lowerLimit': '8.34', 'upperLimit': '12.03'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '0.38'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M12]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '353', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA (PI [M12]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '352', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M12]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '352', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M12]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '343', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M12]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M12]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '354', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M12]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M12]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '354', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 1', 'description': 'The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.'}, {'type': 'SECONDARY', 'title': 'rSBA Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M12])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2084.9', 'groupId': 'OG000', 'lowerLimit': '1888.3', 'upperLimit': '2302'}, {'value': '1099.1', 'groupId': 'OG001', 'lowerLimit': '931.6', 'upperLimit': '1296.7'}]}]}, {'title': 'rSBA-MenC (PI [M12])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1848.6', 'groupId': 'OG000', 'lowerLimit': '1620.3', 'upperLimit': '2109.2'}, {'value': '1876.5', 'groupId': 'OG001', 'lowerLimit': '1400.7', 'upperLimit': '2514'}]}]}, {'title': 'rSBA-MenW-135 (PI [M12])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2993.5', 'groupId': 'OG000', 'lowerLimit': '2618.8', 'upperLimit': '3421.9'}, {'value': '699.9', 'groupId': 'OG001', 'lowerLimit': '569.3', 'upperLimit': '860.4'}]}]}, {'title': 'rSBA-MenY (PI [M12])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4207.1', 'groupId': 'OG000', 'lowerLimit': '3767.3', 'upperLimit': '4698.3'}, {'value': '1386.5', 'groupId': 'OG001', 'lowerLimit': '1104.2', 'upperLimit': '1740.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 1', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M24]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '337', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA (PI [M24]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M24]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '343', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M24]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M24]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M24]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '341', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M24]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M24]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '342', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 2', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.'}, {'type': 'SECONDARY', 'title': 'rSBA Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M24])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1326.8', 'groupId': 'OG000', 'lowerLimit': '1197.7', 'upperLimit': '1469.7'}, {'value': '698.9', 'groupId': 'OG001', 'lowerLimit': '561.2', 'upperLimit': '870.4'}]}]}, {'title': 'rSBA-MenC (PI [M24])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1162', 'groupId': 'OG000', 'lowerLimit': '1013.1', 'upperLimit': '1332.9'}, {'value': '1229.4', 'groupId': 'OG001', 'lowerLimit': '876.4', 'upperLimit': '1724.7'}]}]}, {'title': 'rSBA-MenW-135 (PI [M24])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1984.6', 'groupId': 'OG000', 'lowerLimit': '1757.1', 'upperLimit': '2241.4'}, {'value': '319.1', 'groupId': 'OG001', 'lowerLimit': '228', 'upperLimit': '446.5'}]}]}, {'title': 'rSBA-MenY (PI [M24])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3042.1', 'groupId': 'OG000', 'lowerLimit': '2692.2', 'upperLimit': '3437.5'}, {'value': '850.2', 'groupId': 'OG001', 'lowerLimit': '667.5', 'upperLimit': '1082.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 2', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titre', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M36]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA (PI [M36]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M36]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '334', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M36]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '313', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M36]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M36]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M36]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '337', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M36]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 3', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.'}, {'type': 'SECONDARY', 'title': 'rSBA Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M36])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1238.4', 'groupId': 'OG000', 'lowerLimit': '1126', 'upperLimit': '1361.9'}, {'value': '596.9', 'groupId': 'OG001', 'lowerLimit': '488.5', 'upperLimit': '729.3'}]}]}, {'title': 'rSBA-MenC (PI [M36])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '870.3', 'groupId': 'OG000', 'lowerLimit': '757.1', 'upperLimit': '1000.4'}, {'value': '1124.8', 'groupId': 'OG001', 'lowerLimit': '812.3', 'upperLimit': '1557.6'}]}]}, {'title': 'rSBA-MenW-135 (PI [M36])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2109.2', 'groupId': 'OG000', 'lowerLimit': '1842.5', 'upperLimit': '2414.5'}, {'value': '332.8', 'groupId': 'OG001', 'lowerLimit': '224.4', 'upperLimit': '493.8'}]}]}, {'title': 'rSBA-MenY (PI [M36])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2567.3', 'groupId': 'OG000', 'lowerLimit': '2288.6', 'upperLimit': '2879.8'}, {'value': '848', 'groupId': 'OG001', 'lowerLimit': '682.6', 'upperLimit': '1053.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 3', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M48]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA (PI [M48]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M48]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M48]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M48]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M48]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M48]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M48]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 4', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.'}, {'type': 'SECONDARY', 'title': 'rSBA Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M48])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '278.6', 'groupId': 'OG000', 'lowerLimit': '219.7', 'upperLimit': '353.2'}, {'value': '105.4', 'groupId': 'OG001', 'lowerLimit': '67.6', 'upperLimit': '164.4'}]}]}, {'title': 'rSBA-MenC (PI [M48])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '273.6', 'groupId': 'OG000', 'lowerLimit': '220.6', 'upperLimit': '339.4'}, {'value': '315', 'groupId': 'OG001', 'lowerLimit': '196.8', 'upperLimit': '504.1'}]}]}, {'title': 'rSBA-MenW-135 (PI [M48])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '175.1', 'groupId': 'OG000', 'lowerLimit': '131.5', 'upperLimit': '233'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '16.3'}]}]}, {'title': 'rSBA-MenY (PI [M48])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '350.5', 'groupId': 'OG000', 'lowerLimit': '268.9', 'upperLimit': '456.7'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '40.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 4', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M60]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA (PI [M60]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M60]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC (PI [M60]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M60]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 (PI [M60]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M60]) ≥ 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY (PI [M60]) ≥ 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 5', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.'}, {'type': 'SECONDARY', 'title': 'rSBA Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'rSBA-MenA (PI [M60])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '189.8', 'groupId': 'OG000', 'lowerLimit': '107.7', 'upperLimit': '334.6'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '108.7'}]}]}, {'title': 'rSBA-MenC (PI [M60])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '147.4'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '49.7'}]}]}, {'title': 'rSBA-MenW-135 (PI [M60])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '281.6', 'groupId': 'OG000', 'lowerLimit': '145.9', 'upperLimit': '543.2'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '41.9'}]}]}, {'title': 'rSBA-MenY (PI [M60])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '769.7', 'groupId': 'OG000', 'lowerLimit': '438.6', 'upperLimit': '1351'}, {'value': '74.1', 'groupId': 'OG001', 'lowerLimit': '21.9', 'upperLimit': '250.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 5', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-PS Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-PSA (PI [M12]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA (PI [M12]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PI [M12]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PI [M12]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PI [M12]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '342', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PI [M12]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PI [M12]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PI [M12]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 1', 'description': 'The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.'}, {'type': 'SECONDARY', 'title': 'Concentration of Anti-PS Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-PSA (PI [M12])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.25', 'groupId': 'OG000', 'lowerLimit': '19.78', 'upperLimit': '27.32'}, {'value': '31.72', 'groupId': 'OG001', 'lowerLimit': '24.77', 'upperLimit': '40.63'}]}]}, {'title': 'Anti-PSC (PI [M12])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.67', 'groupId': 'OG000', 'lowerLimit': '4.08', 'upperLimit': '5.33'}, {'value': '24.53', 'groupId': 'OG001', 'lowerLimit': '19.92', 'upperLimit': '30.2'}]}]}, {'title': 'Anti-PSW-135 (PI [M12])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.48', 'groupId': 'OG000', 'lowerLimit': '4.68', 'upperLimit': '6.4'}, {'value': '10.39', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '13.85'}]}]}, {'title': 'Anti-PSY (PI [M12])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.68', 'groupId': 'OG000', 'lowerLimit': '5.69', 'upperLimit': '7.85'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '21.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 1', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-PS Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-PSA (PI [M24]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA (PI [M24]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '301', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PI [M24]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PI [M24]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PI [M24]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PI [M24]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PI [M24]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '325', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PI [M24]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 2', 'description': 'The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.'}, {'type': 'SECONDARY', 'title': 'Concentration of Anti-PS Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-PSA (PI [M24])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.15', 'groupId': 'OG000', 'lowerLimit': '12.76', 'upperLimit': '17.98'}, {'value': '24.85', 'groupId': 'OG001', 'lowerLimit': '19.08', 'upperLimit': '32.36'}]}]}, {'title': 'Anti-PSC (PI [M24])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.62', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '3.03'}, {'value': '15.74', 'groupId': 'OG001', 'lowerLimit': '12.56', 'upperLimit': '19.72'}]}]}, {'title': 'Anti-PSW-135 (PI [M24])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.51', 'groupId': 'OG000', 'lowerLimit': '2.98', 'upperLimit': '4.15'}, {'value': '6.76', 'groupId': 'OG001', 'lowerLimit': '5.08', 'upperLimit': '9.01'}]}]}, {'title': 'Anti-PSY (PI [M24])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.44', 'groupId': 'OG000', 'lowerLimit': '3.73', 'upperLimit': '5.3'}, {'value': '11.11', 'groupId': 'OG001', 'lowerLimit': '8.39', 'upperLimit': '14.71'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 2', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point..'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-PS Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-PSA (PI [M36]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '328', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA (PI [M36]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PI [M36]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC (PI [M36]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PI [M36]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '303', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 (PI [M36]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PI [M36]) ≥ 0.3 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY (PI [M36]) ≥ 2.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 3', 'description': 'The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.'}, {'type': 'SECONDARY', 'title': 'Concentration of Anti-PS Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-PSA (PI [M36])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '14.6'}, {'value': '19.8', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '24.9'}]}]}, {'title': 'Anti-PSC (PI [M36])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '3'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '17.2'}]}]}, {'title': 'Anti-PSW-135 (PI [M36])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '3.4'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '7.2'}]}]}, {'title': 'Anti-PSY (PI [M36])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '4.5'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '10.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 3', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '≥ 37.5 ˚C Fever', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '>39.5 ˚C Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were fatigue, fever \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available and who had the symptoms sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With New Onset of Chronic Illnesses (NOCIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to 6 Months after vaccination', 'description': 'NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to 6 Months after vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With AEs Resulting in Emergency Rooms Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to 6 Months after vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 31 Days after vaccination', 'description': 'An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to 6 Months after vaccination', '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, which included all vaccinated subjects from whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'OG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'classes': [{'title': 'Any (SAE)s Year 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any (SAE)s Year 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any (SAE)s Year 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any (SAE)s Year 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any (SAE)s Year 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 1, Year 2, Year 3, Year 4 and Year 5', '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, which included all vaccinated subjects from whom data were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.'}, {'id': 'FG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}], 'periods': [{'title': 'Active Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '374'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '372'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Year 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Year 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Year 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Year 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '317'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '317'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Year 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nimenrix Group', 'description': 'Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.'}, {'id': 'BG001', 'title': 'Mencevax Group', 'description': 'Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '7.62', 'groupId': 'BG000'}, {'value': '19.3', 'spread': '8.58', 'groupId': 'BG001'}, {'value': '18.78', 'spread': '7.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic ancestry', 'categories': [{'title': 'Asian-East Asian heritage', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian-South East Asian heritage', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'title': 'White-Arabic/North African heritage', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'dispFirstSubmitDate': '2012-07-26', 'completionDateStruct': {'date': '2008-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2006-07-25', 'dispFirstSubmitQcDate': '2012-07-26', 'resultsFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2006-07-25', 'dispFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-08', 'studyFirstPostDateStruct': {'date': '2006-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)', 'timeFrame': 'One month post vaccination', 'description': 'Response to vaccine antigen was defined as: for initially seronegative subjects \\[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.'}, {'measure': 'Occurrence of Any Grade 3 Systemic Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\\>) 50 millimeters (mm).\n\nGeneral symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \\>39.5 °C.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128.'}, {'measure': 'rSBA Antibody Titers', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.'}, {'measure': 'Concentration of Anti-PS Antibodies', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).'}, {'measure': 'Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).'}, {'measure': 'Concentration of Anti-TT Antibodies', 'timeFrame': 'Prior to and 1 Month after vaccination', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).'}, {'measure': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'timeFrame': 'At Year 1', 'description': 'The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.'}, {'measure': 'rSBA Antibody Titers', 'timeFrame': 'At Year 1', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'timeFrame': 'At Year 2', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.'}, {'measure': 'rSBA Antibody Titers', 'timeFrame': 'At Year 2', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'timeFrame': 'At Year 3', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.'}, {'measure': 'rSBA Antibody Titers', 'timeFrame': 'At Year 3', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'timeFrame': 'At Year 4', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.'}, {'measure': 'rSBA Antibody Titers', 'timeFrame': 'At Year 4', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value', 'timeFrame': 'At Year 5', 'description': 'The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.'}, {'measure': 'rSBA Antibody Titers', 'timeFrame': 'At Year 5', 'description': 'Antibody titers are presented as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Subjects With Anti-PS Antibodies', 'timeFrame': 'At Year 1', 'description': 'The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.'}, {'measure': 'Concentration of Anti-PS Antibodies', 'timeFrame': 'At Year 1', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.'}, {'measure': 'Number of Subjects With Anti-PS Antibodies', 'timeFrame': 'At Year 2', 'description': 'The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.'}, {'measure': 'Concentration of Anti-PS Antibodies', 'timeFrame': 'At Year 2', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.'}, {'measure': 'Number of Subjects With Anti-PS Antibodies', 'timeFrame': 'At Year 3', 'description': 'The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.'}, {'measure': 'Concentration of Anti-PS Antibodies', 'timeFrame': 'At Year 3', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were fatigue, fever \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With New Onset of Chronic Illnesses (NOCIs)', 'timeFrame': 'From Day 0 up to 6 Months after vaccination', 'description': 'NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.'}, {'measure': 'Number of Subjects With Rash', 'timeFrame': 'From Day 0 up to 6 Months after vaccination'}, {'measure': 'Number of Subjects With AEs Resulting in Emergency Rooms Visits', 'timeFrame': 'From Day 0 up to 6 Months after vaccination'}, {'measure': 'Number of Subjects With Unsolicited AEs', 'timeFrame': 'Up to 31 Days after vaccination', 'description': 'An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 up to 6 Months after vaccination', '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': 'Number of Subjects With SAEs', 'timeFrame': 'At Year 1, Year 2, Year 3, Year 4 and Year 5', 'description': 'SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}]}, 'conditionsModule': {'keywords': ['Immunogenicity', 'Healthy', 'Persistence', 'Meningococcal vaccine', 'Non-inferiority', 'Meningococcal A C W Y Diseases', 'meningococcal serogroups A, C, W & Y diseases'], 'conditions': ['Infections, Meningococcal']}, 'referencesModule': {'availIpds': [{'id': '107386', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107386', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107386', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107386', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107386', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107386', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '26437712', 'type': 'DERIVED', 'citation': 'Borja-Tabora CF, Montalban C, Memish ZA, Boutriau D, Kolhe D, Miller JM, Van der Wielen M. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015 Oct 6;15:409. doi: 10.1186/s12879-015-1138-y.'}, {'pmid': '23510357', 'type': 'DERIVED', 'citation': 'Borja-Tabora C, Montalban C, Memish ZA, Van der Wielen M, Bianco V, Boutriau D, Miller J. Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study. BMC Infect Dis. 2013 Mar 5;13:116. doi: 10.1186/1471-2334-13-116.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives \\& outcome measures of both the primary \\& extension phases.', 'detailedDescription': 'All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol.\n* A male or female between, and including, 11 and 55 years of age at the time of vaccination.\n* Written informed consent obtained from the subject/ from the parent or legally acceptable representative of the subject.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* Previously completed routine childhood vaccinations to the best of his/her knowledge and/or his/her parents/legally acceptable representative's knowledge.\n* If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, and must agree to continue such precautions for two months after completion of the vaccination series. Female subjects in childbearing potential who are not abstinent must have a negative pregnancy test.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).\n* Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y within the last five previous years.\n* Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y.\n* History of meningococcal disease due to serogroup A, C, W or Y.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.\n* A family history of congenital or hereditary immunodeficiency.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Major congenital defects or serious chronic illness.\n* History of any neurologic disorders or seizures.\n* History of Guillain-Barré syndrome.\n* Acute disease at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* Pregnant or lactating female.\n* History of chronic alcohol consumption and/or drug abuse.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions.\n\nSpecific criteria to be checked at each study visit for the long term follow-up:\n\n* History of meningococcal serogroup A,C, W and Y disease.\n* Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol."}, 'identificationModule': {'nctId': 'NCT00356369', 'briefTitle': 'Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine', 'nctIdAliases': ['NCT00356499', 'NCT00356538', 'NCT00356577', 'NCT00356694', 'NCT00356876'], 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine (Intramuscularly) vs Mencevax ACWY (Subcutaneously) to Healthy Subjects (11-55 Years of Age)", 'orgStudyIdInfo': {'id': '107386'}, 'secondaryIdInfos': [{'id': '107392 (Ext: Y1)', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '107398 (Ext: Y2)', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '107402 (Ext: Y3)', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '107404 (Ext: Y4)', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '107406 (Ext: Y5)', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimenrix Group', 'description': "Subjects receiving GSK Biologicals' meningococcal vaccine 134612", 'interventionNames': ['Biological: meningococcal ACWY (vaccine)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mencevax Group', 'description': 'Subjects receiving Mencevax™ ACWY', 'interventionNames': ['Biological: Mencevax™ ACWY']}], 'interventions': [{'name': 'meningococcal ACWY (vaccine)', 'type': 'BIOLOGICAL', 'description': 'One intramuscular dose.', 'armGroupLabels': ['Nimenrix Group']}, {'name': 'Mencevax™ ACWY', 'type': 'BIOLOGICAL', 'description': 'One subcutaneous dose.', 'armGroupLabels': ['Mencevax Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1781', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}