Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-03-29 @ 10:58 PM
Study NCT ID:
NCT00514904
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2007-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Tunisia']}, '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'}]}}, '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': 'Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period 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 received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.', 'otherNumAtRisk': 1125, 'deathsNumAtRisk': 1125, 'otherNumAffected': 416, 'seriousNumAtRisk': 1125, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.', 'otherNumAtRisk': 376, 'deathsNumAtRisk': 376, 'otherNumAffected': 155, 'seriousNumAtRisk': 376, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Pain (< 6 years of age)', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects \\< 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Redness (< 6 years of age)', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects \\< 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Swelling (< 6 years of age)', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects 2-5 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain (≥ 6 years of age)', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Redness (≥ 6 years of age)', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 542, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Swelling (≥ 6 years of age)', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 542, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drowsiness', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects \\< 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fever (Orally) (< 6 years of age)', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects \\< 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Irritability', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects \\< 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Loss of appetite', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects \\< 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 542, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fever (Orally) (≥ 6 years of age)', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 542, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 542, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'notes': 'Assessed during the 4-day (Days 0-3) post-vaccination period in subjects ≥ 6 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 542, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Food intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Typhoid fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Parasitic gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '723', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'rSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '529', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '664', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '673', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '723', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '670', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.77', 'ciLowerLimit': '10.26', 'ciUpperLimit': '20.23', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] greater than or equal to (≥) -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.47', 'ciLowerLimit': '17.52', 'ciUpperLimit': '31.87', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥-10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.35', 'ciLowerLimit': '2.68', 'ciUpperLimit': '11.08', 'statisticalMethod': 'Difference in percentage', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥-10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.92', 'ciLowerLimit': '18.02', 'ciUpperLimit': '30.3', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥-10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after vaccination (Post-vaccination, study Month 1)', 'description': 'Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).', '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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1125', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.34', 'ciLowerLimit': '0.56', 'ciUpperLimit': '20.25', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for assessment: upper limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the ratio between Nimenrix Group and Mencevax ACWY Group being lower than or equal to the pre-defined clinical limit ratio of 3.0 in the percentage of subjects with any grade 3 general symptoms.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Grade 3 symptom was defined as symptom that prevented normal, everyday activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'rSBA-MenA ≥ 1:8, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '491', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA≥ 1:8, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '739', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA ≥ 1:128, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '476', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenA≥ 1:128, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '739', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC≥ 1:8, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC≥ 1:8, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '738', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC ≥ 1:128 M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC ≥ 1:128 M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '736', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 ≥ 1:8, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '455', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 ≥ 1:8, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '742', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135. ≥ 1:128 M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '389', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135 ≥ 1:128 M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '742', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY ≥ 1:8, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '725', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '630', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY ≥ 1:8, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '742', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY≥ 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Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. 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Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'Anti-TT, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '743', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.577', 'upperLimit': '0.731'}, {'value': '0.744', 'groupId': 'OG001', 'lowerLimit': '0.609', 'upperLimit': '0.908'}]}]}, {'title': 'Anti-TT, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.731', 'groupId': 'OG000', 'lowerLimit': '19.821', 'upperLimit': '23.825'}, {'value': '0.709', 'groupId': 'OG001', 'lowerLimit': '0.581', 'upperLimit': '0.866'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination (Month 1)', 'description': 'Antibody concentrations were expressed as geometric mean concentrations (GMCs)', '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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'Anti-PSA ≥ 0.3 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA ≥ 0.3 μg/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '369', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA ≥ 2.0 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSA ≥ 2.0 μg/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '368', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC ≥ 0.3 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC ≥ 0.3 μg/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC ≥ 2.0 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSC ≥ 2.0 μg/mL M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '363', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 ≥ 0.3 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 ≥ 0.3 μg/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '368', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 ≥ 2.0 μg/mL M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSW-135 ≥ 2.0 μg/mL M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '353', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY ≥ 0.3 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY ≥ 0.3 μg/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '369', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY ≥ 2.0 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PSY ≥ 2.0 μg/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '362', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination, (Month 1)', 'description': 'The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.', '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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-polysaccharide (Anti-PS) Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'Anti-PSA, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.46'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.36'}]}]}, {'title': 'Anti-PSA, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '71.34', 'upperLimit': '92.2'}, {'value': '25.43', 'groupId': 'OG001', 'lowerLimit': '19.66', 'upperLimit': '32.9'}]}]}, {'title': 'Anti-PSC, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.19'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.18'}]}]}, {'title': 'Anti-PSC, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.61', 'groupId': 'OG000', 'lowerLimit': '20.24', 'upperLimit': '25.25'}, {'value': '25.69', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '30.99'}]}]}, {'title': 'Anti-PSW-135, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.18'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.16', 'upperLimit': '0.19'}]}]}, {'title': 'Anti-PSW-135, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '11.32', 'upperLimit': '14.48'}, {'value': '13.85', 'groupId': 'OG001', 'lowerLimit': '10.93', 'upperLimit': '17.53'}]}]}, {'title': 'Anti-PSY, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.2'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.23'}]}]}, {'title': 'Anti-PSY, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.26', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '21.69'}, {'value': '22.71', 'groupId': 'OG001', 'lowerLimit': '18.13', 'upperLimit': '28.46'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination (Month 1)', 'description': 'Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.', '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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '575', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '542', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.', '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 with the symptom sheet filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects < 6 Years of Age With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '575', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Fever ≥ 37.5°C', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of apptite', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after vaccination', 'description': 'Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '542', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Fever ≥ 37.5°C', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after vaccination', 'description': 'Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.', '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 with the symptom sheet filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Specific Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1125', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'title': 'Rash (es)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'NOCI (s)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ER visit (s)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to 6 months after vaccination', 'description': 'Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Unsolicited Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1125', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to one month (Day 0-Day 30) after vaccination', 'description': 'Unsolicited symptom covers any symptom 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1125', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', '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, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'FG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1125'}, {'groupId': 'FG001', 'numSubjects': '376'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1101'}, {'groupId': 'FG001', 'numSubjects': '371'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 1504 subjects were enrolled into the study, and 1501 of them were vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1125', 'groupId': 'BG000'}, {'value': '376', 'groupId': 'BG001'}, {'value': '1501', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'BG001', 'title': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '2.49', 'groupId': 'BG000'}, {'value': '5.5', 'spread': '2.45', 'groupId': 'BG001'}, {'value': '5.57', 'spread': '2.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '526', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '701', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '599', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '800', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - Central/ South Asian heritage, n(%)', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Japanese heritage, n(%)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian - South East Asian heritage, n(%)', 'categories': [{'measurements': [{'value': '597', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '796', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander, n(%)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic/ North African heritage, n(%)', 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}, {'title': 'White - Caucasian/ European heritage, n(%)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2009-09-03', 'completionDateStruct': {'date': '2009-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2007-08-09', 'dispFirstSubmitQcDate': '2009-09-03', 'resultsFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2007-08-09', 'dispFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-11', 'studyFirstPostDateStruct': {'date': '2007-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135', 'timeFrame': 'One month after vaccination (Post-vaccination, study Month 1)', 'description': 'Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).'}, {'measure': 'Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Grade 3 symptom was defined as symptom that prevented normal, everyday activities.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination (Month 1)', 'description': 'The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.'}, {'measure': 'rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination (Month 1)', 'description': 'Antibody titers were expressed as geometric mean titers (GMTs).'}, {'measure': 'Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination (Month 1)', 'description': 'The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.'}, {'measure': 'Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination (Month 1)', 'description': 'Antibody concentrations were expressed as geometric mean concentrations (GMCs)'}, {'measure': 'Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination, (Month 1)', 'description': 'The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.'}, {'measure': 'Anti-polysaccharide (Anti-PS) Antibody Concentrations', 'timeFrame': 'Pre vaccination (Month 0) and post vaccination (Month 1)', 'description': 'Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.'}, {'measure': 'Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects < 6 Years of Age With Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after vaccination', 'description': 'Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.'}, {'measure': 'Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after vaccination', 'description': 'Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.'}, {'measure': 'Number of Subjects Reporting Specific Adverse Events (AEs)', 'timeFrame': 'From Day 0 up to 6 months after vaccination', 'description': 'Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits.'}, {'measure': 'Number of Subjects Reporting Any Unsolicited Symptoms', 'timeFrame': 'Up to one month (Day 0-Day 30) after vaccination', 'description': 'Unsolicited symptom covers any symptom 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.'}, {'measure': 'Number of Subjects Reporting Any 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, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.'}]}, 'conditionsModule': {'keywords': ['safety', 'meningococcal vaccine', 'immunogenicity'], 'conditions': ['Infections, Meningococcal', 'Meningococcal Vaccines']}, 'referencesModule': {'availIpds': [{'id': '109495', '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': '109495', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109495', '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': '109495', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109495', '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': '109495', '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': '109495', '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': '21278617', 'type': 'BACKGROUND', 'citation': 'Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J. 2011 Apr;30(4):e56-62. doi: 10.1097/INF.0b013e31820e6e02.'}], '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': 'The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.', 'detailedDescription': 'Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.\n* A male or female between, and including, 2 and 10 years of age at the time of vaccination.\n* Written informed consent obtained from the parent or guardian of the subject.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.\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 first 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 first vaccine dose.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.\n* Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).\n* Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.\n* Previous vaccination with tetanus toxoid within the last month.\n* History of meningococcal disease.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination..\n* History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).\n* Major congenital defects or serious chronic illness.\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."}, 'identificationModule': {'nctId': 'NCT00514904', 'briefTitle': 'Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age", 'orgStudyIdInfo': {'id': '109495'}, 'secondaryIdInfos': [{'id': '2012-000283-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.', 'interventionNames': ['Biological: Nimenrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mencevax ACWY Group', 'description': 'Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.', 'interventionNames': ['Biological: Mencevax']}], 'interventions': [{'name': 'Nimenrix', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal vaccine GSK134612'], 'description': 'Single dose, intramuscular injection', 'armGroupLabels': ['Nimenrix Group']}, {'name': 'Mencevax', 'type': 'BIOLOGICAL', 'description': 'Single dose, subcutaneous injection', 'armGroupLabels': ['Mencevax ACWY Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '403202', 'city': 'Goa', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.60243, 'lon': 72.72583}}, {'zip': '452001', 'city': 'Indore', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'zip': '110002', 'city': 'New Delhi', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '632004', 'city': 'Vellore', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'zip': '1107-2020', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '1008', 'city': 'Sampaloc, Manila', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'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'}}}}