Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-03 @ 10:45 PM
Study NCT ID:
NCT00282295
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2006-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505143', 'term': 'Boostrix'}, {'id': 'D022401', 'term': 'Meningococcal Vaccines'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'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}, 'limitationsAndCaveats': {'description': 'None reported.'}}, 'adverseEventsModule': {'timeFrame': 'Solicited local and general symptoms during the 4-day (Day 0-3) follow-up period, unsolicited AEs during the 31-day (Day 0-30) follow-up period after each vaccination and SAEs throughout the study (Day 0 - Month 2).', 'eventGroups': [{'id': 'EG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.', 'otherNumAtRisk': 446, 'otherNumAffected': 371, 'seriousNumAtRisk': 446, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.', 'otherNumAtRisk': 446, 'otherNumAffected': 385, 'seriousNumAtRisk': 446, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.', 'otherNumAtRisk': 449, 'otherNumAffected': 358, 'seriousNumAtRisk': 449, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 331}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 343}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 291}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 141}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 119}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 175}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 160}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fever (orally)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 80}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 177}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 157}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Extradural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 449, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '0.79', 'ciUpperLimit': '4.17', 'groupDescription': 'The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was greater than (\\>) the pre-defined limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.48', 'groupDescription': 'Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority objective was demonstrated if the lower limit was greater than (\\>) the pre-defined limit of -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 1 (post Boostrix vaccination)', 'description': 'Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available and (\\&) randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'PRIMARY', 'title': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000', 'lowerLimit': '58.6', 'upperLimit': '69.7'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '67.9', 'upperLimit': '81.3'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '444.8', 'groupId': 'OG000', 'lowerLimit': '415.0', 'upperLimit': '476.7'}, {'value': '575.8', 'groupId': 'OG001', 'lowerLimit': '532.8', 'upperLimit': '622.1'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '253.4', 'groupId': 'OG000', 'lowerLimit': '224.8', 'upperLimit': '285.6'}, {'value': '366.0', 'groupId': 'OG001', 'lowerLimit': '321.6', 'upperLimit': '416.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.03', 'groupDescription': 'Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was greater than (\\>) the pre-defined limit of 0.67'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.84', 'groupDescription': 'Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was \\> the pre-defined limit of 0.67'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.72', 'groupDescription': 'To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was \\> the pre-defined limit of 0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 1 (post Boostrix vaccination)', 'description': 'Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-PT, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '385', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '398', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in booster response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.38', 'ciLowerLimit': '-9.91', 'ciUpperLimit': '1.15', 'groupDescription': 'Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was \\> the pre-defined limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in booster response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.39', 'ciLowerLimit': '-7.03', 'ciUpperLimit': '0.15', 'groupDescription': 'Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was \\> the pre-defined limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in booster response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.96', 'ciLowerLimit': '-5.25', 'ciUpperLimit': '-1.25', 'groupDescription': 'To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was \\> the pre-defined limit of -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 1 (post Boostrix vaccination)', 'description': 'Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as:\n\nfor initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \\< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'rSBA-MenA, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '329', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '369', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '404', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in vaccine response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-4.85', 'ciUpperLimit': '4.43', 'groupDescription': 'Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in vaccine response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '5.16', 'groupDescription': 'Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in vaccine response rate', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '-2.58', 'ciUpperLimit': '6.25', 'groupDescription': 'Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in vaccine response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.56', 'ciLowerLimit': '0.96', 'ciUpperLimit': '6.45', 'groupDescription': 'Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)', 'description': 'Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'ANTI-D, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}]}, {'title': 'ANTI-T, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0 (PRE) before Boostrix vaccination', 'description': 'Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '426', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 2 (one month post Boostrix vaccination)', 'description': 'Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-D, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '399', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}]}]}, {'title': 'Anti-T, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}, {'value': '423', 'groupId': 'OG002'}]}]}, {'title': 'ANTI-D, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}]}, {'title': 'ANTI-T, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)', 'description': 'Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '428', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-D, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '428', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '422', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}, {'value': '422', 'groupId': 'OG002'}]}]}, {'title': 'Anti-T, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '428', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)', 'description': 'Booster responses for anti-D and anti-T antibodies were defined as:\n\nfor initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-D, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.5'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '0.5'}]}]}, {'title': 'Anti-D, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '43.5'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '11.2'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '25.1', 'upperLimit': '29.6'}]}]}, {'title': 'Anti-T, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '0.9'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.0'}]}]}, {'title': 'Anti-T, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '10.2'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '13.8'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '13.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)', '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 cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG001', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '17.6'}, {'value': '41.6', 'groupId': 'OG001', 'lowerLimit': '38.1', 'upperLimit': '45.5'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '10.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)', '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 cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-PT, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '338', 'groupId': 'OG000'}]}]}, {'title': 'Anti-FHA, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '405', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRN, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 2 (one month post Boostrix vaccination)', 'description': 'Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \\< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}, {'value': '428', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '9.6'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '11.3'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '11.6'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '428', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '52.3'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '39.1', 'upperLimit': '49.0'}, {'value': '47.8', 'groupId': 'OG002', 'lowerLimit': '42.4', 'upperLimit': '53.8'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '14.1'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '12.0'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '10.6', 'upperLimit': '13.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 before (PRE) Boostrix vaccination', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '84.6'}]}]}, {'title': 'ANTI-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '653.0', 'groupId': 'OG000', 'lowerLimit': '603.6', 'upperLimit': '706.5'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '412.5', 'groupId': 'OG000', 'lowerLimit': '364.5', 'upperLimit': '466.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 2 (one month post Boostrix vaccination)', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol'}, {'type': 'SECONDARY', 'title': 'Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'rSBA-MenA, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '381', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '533.4', 'groupId': 'OG000', 'lowerLimit': '464.6', 'upperLimit': '612.3'}, {'value': '490.8', 'groupId': 'OG001', 'lowerLimit': '428.4', 'upperLimit': '562.3'}, {'value': '449.4', 'groupId': 'OG002', 'lowerLimit': '383.4', 'upperLimit': '526.6'}]}]}, {'title': 'rSBA-MenA, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '420', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10406.1', 'groupId': 'OG000', 'lowerLimit': '9687.2', 'upperLimit': '11178.3'}, {'value': '7220.0', 'groupId': 'OG001', 'lowerLimit': '6613.3', 'upperLimit': '7882.4'}, {'value': '9466.3', 'groupId': 'OG002', 'lowerLimit': '8765.6', 'upperLimit': '10222.9'}]}]}, {'title': 'rSBA-MenC, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}, {'value': '417', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '25.5'}, {'value': '16.4', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '19.8'}, {'value': '18.7', 'groupId': 'OG002', 'lowerLimit': '15.3', 'upperLimit': '22.8'}]}]}, {'title': 'rSBA-MenC, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2760.2', 'groupId': 'OG000', 'lowerLimit': '2387.5', 'upperLimit': '3191.1'}, {'value': '1137.0', 'groupId': 'OG001', 'lowerLimit': '969.6', 'upperLimit': '1333.3'}, {'value': '2702.8', 'groupId': 'OG002', 'lowerLimit': '2292.6', 'upperLimit': '3186.5'}]}]}, {'title': 'rSBA-MenY, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}, {'value': '413', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '43.6', 'upperLimit': '66.5'}, {'value': '51.4', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '63.5'}, {'value': '56.2', 'groupId': 'OG002', 'lowerLimit': '45.1', 'upperLimit': '70.1'}]}]}, {'title': 'rSBA-MenY, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3244.2', 'groupId': 'OG000', 'lowerLimit': '2884.1', 'upperLimit': '3649.1'}, {'value': '1470.7', 'groupId': 'OG001', 'lowerLimit': '1311.4', 'upperLimit': '1649.3'}, {'value': '3022.8', 'groupId': 'OG002', 'lowerLimit': '2687.0', 'upperLimit': '3400.6'}]}]}, {'title': 'rSBA-MenW-135, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}, {'value': '422', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '28.6'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '34.0'}, {'value': '32.2', 'groupId': 'OG002', 'lowerLimit': '26.6', 'upperLimit': '39.0'}]}]}, {'title': 'rSBA-MenW-135, POST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4822.1', 'groupId': 'OG000', 'lowerLimit': '4351.6', 'upperLimit': '5343.4'}, {'value': '2143.1', 'groupId': 'OG001', 'lowerLimit': '1913.9', 'upperLimit': '2399.8'}, {'value': '4154.3', 'groupId': 'OG002', 'lowerLimit': '3690.9', 'upperLimit': '4675.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)', 'description': 'Antibody titers are presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'rSBA-MenA, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}]}]}, {'title': 'rSBA-MenC, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}]}]}, {'title': 'rSBA-MenY, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '325', 'groupId': 'OG000'}]}]}, {'title': 'rSBA-MenW-135, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 2 (one month after vaccination with Menactra vaccine)', 'description': 'Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \\& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \\& had not received a vaccine not specified or forbidden by the protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Pain, Any, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '331', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}]}]}, {'title': 'Pain, Grade 3, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Redness, Any, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'Redness, ≥ 50 mm, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Swelling, Any, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Swelling, ≥ 50 mm, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Pain, Any, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}]}, {'title': 'Pain, Grade 3, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Redness, Any, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}, {'title': 'Redness, ≥ 50 mm, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Swelling, Any, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Swelling, ≥ 50 mm, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Pain, Any, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '331', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}]}]}, {'title': 'Pain, Grade 3, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Redness, Any, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Redness, ≥ 50 mm, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Swelling, Any, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'Swelling, ≥ 50 mm, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4-days (Day 0-3) after each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}, {'value': '449', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Fatigue, Any, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Grade 3, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Related, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Any, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Grade 3, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Related, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt., Any, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt, Grade 3, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt, Related, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Any, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Grade 3, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Related, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Any, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Grade 3, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Related, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Any, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Grade 3, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Related, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt., Any, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt., Grade 3, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt., Related, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Any, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Grade 3, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Related, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable, as both vaccines were administered at the same timepoint.', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Any, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Grade 3, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Related, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Any, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Grade 3, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fever (orally), Related, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt., Any, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt., Grade 3, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Gastro sympt., Related, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Any, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Grade 3, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Related, Across', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4-days (Days 0-3) after each dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, fever \\[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\\], headache and gastrointestinal symptoms \\[gastro sympt\\]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (\\>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}, {'value': '449', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 31-day (Days 0-30) period after each 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. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. 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 subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}, {'value': '449', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'OG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'OG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the entire study period (Day 0 - Month 2)', 'description': 'Serious adverse events (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 subjects with at least one vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'FG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'FG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '446'}, {'groupId': 'FG001', 'numSubjects': '446'}, {'groupId': 'FG002', 'numSubjects': '449'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '443'}, {'groupId': 'FG001', 'numSubjects': '429'}, {'groupId': 'FG002', 'numSubjects': '441'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Serious Adverse Events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Out of 1344 subjects enrolled, only 1341 were vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '446', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}, {'value': '1341', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.'}, {'id': 'BG001', 'title': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'BG002', 'title': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '2.31', 'groupId': 'BG000'}, {'value': '13.2', 'spread': '2.07', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '2.27', 'groupId': 'BG002'}, {'value': '13.37', 'spread': '2.22', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}, {'value': '666', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}, {'value': '675', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1344}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2006-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2006-01-25', 'resultsFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2006-01-25', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-23', 'studyFirstPostDateStruct': {'date': '2006-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies', 'timeFrame': 'At Month 1 (post Boostrix vaccination)', 'description': 'Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).'}, {'measure': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations', 'timeFrame': 'At Month 1 (post Boostrix vaccination)', 'description': 'Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).'}, {'measure': 'Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies', 'timeFrame': 'At Month 1 (post Boostrix vaccination)', 'description': 'Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as:\n\nfor initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \\< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.'}, {'measure': 'Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)', 'timeFrame': 'One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)', 'description': 'Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies', 'timeFrame': 'At Day 0 (PRE) before Boostrix vaccination', 'description': 'Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).'}, {'measure': 'Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies', 'timeFrame': 'At Month 2 (one month post Boostrix vaccination)', 'description': 'Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).'}, {'measure': 'Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens', 'timeFrame': 'PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)', 'description': 'Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).'}, {'measure': 'Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies', 'timeFrame': 'At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)', 'description': 'Booster responses for anti-D and anti-T antibodies were defined as:\n\nfor initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.'}, {'measure': 'Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations', 'timeFrame': 'PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).'}, {'measure': 'Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations', 'timeFrame': 'At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).'}, {'measure': 'Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies', 'timeFrame': 'At Month 2 (one month post Boostrix vaccination)', 'description': 'Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \\< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.'}, {'measure': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations', 'timeFrame': 'At Day 0 before (PRE) Boostrix vaccination', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).'}, {'measure': 'Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations', 'timeFrame': 'At Month 2 (one month post Boostrix vaccination)', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).'}, {'measure': 'Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies', 'timeFrame': 'PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)', 'description': 'Antibody titers are presented as geometric mean titers (GMTs).'}, {'measure': 'Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies', 'timeFrame': 'At Month 2 (one month after vaccination with Menactra vaccine)', 'description': 'Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra vaccine.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'Within 4-days (Day 0-3) after each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'Within 4-days (Days 0-3) after each dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, fever \\[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\\], headache and gastrointestinal symptoms \\[gastro sympt\\]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (\\>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within the 31-day (Days 0-30) period after each 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. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'Throughout the entire study period (Day 0 - Month 2)', 'description': 'Serious adverse events (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': ['tetanus', 'pertussis', 'Prophylaxis', 'meningococcus', 'diptheria'], 'conditions': ['Acellular Pertussis', 'Tetanus', 'Diphtheria']}, 'referencesModule': {'availIpds': [{'id': '105753', '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': '105753', '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': '105753', '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': '105753', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '105753', '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': '105753', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'type': 'RESULT', 'citation': 'Friedland et al. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines. Accepted for poster presentation at ICAAC 2007'}, {'type': 'RESULT', 'citation': 'Weston et al. Reactogenicity of concomitant and separately administered Tdap and MCV4 vaccines. Accepted for poster presentation at ICAAC 2007'}, {'pmid': '21134450', 'type': 'DERIVED', 'citation': 'Weston WM, Friedland LR, Wu X, Howe B. Immunogenicity and reactogenicity of co-administered tetanus-diphtheria-acellular pertussis (Tdap) and tetravalent meningococcal conjugate (MCV4) vaccines compared to their separate administration. Vaccine. 2011 Jan 29;29(5):1017-22. doi: 10.1016/j.vaccine.2010.11.057. Epub 2010 Dec 4.'}], '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': 'New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.', 'detailedDescription': 'A phase IV, randomized, partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with GlaxoSmithKline\'s tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed \\[Tdap Boostrix®\\] co-administered intramuscularly with Aventis-Pasteur\'s meningococcal (serogroups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the administration of either vaccine alone in healthy adolescents 11-18 years of age. "Experimental design: Prospective, randomized, controlled multicenter study with three groups:\n\nGroup 1: Boostrix + Menactra on Day 0, blood samples at Month 0 and Month 1 Group 2: Boostrix on Day 0, Menactra at Month 1, blood samples at Month 0, Month 1, and Month 2 Group 3: Menactra on Day 0, Boostrix at Month 1, blood samples at Month 0, Month 1 and Month 2 Treatment allocation: randomized 1:1:1 Type of study: self-contained Duration of the study: Approximately one month for each subject in Group 1 and approximately two months for each subject in the Group 2 and Group 3."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects as established by medical history and history-directed physical examination before entering into the study.\n* Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.\n* Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.\n\nExclusion Criteria:\n\n* Administration of a pre-school booster of DTP vaccine within the previous 5 years\n* Administration of a diphteria-tetanus (Td) booster within the previous 5 years\n* Previous vaccination against N. meningitidis\n* Hypersensitivity to latex\n* History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines\n* History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause\n* Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized\n* Previous history of Guillain-Barré syndrome'}, 'identificationModule': {'nctId': 'NCT00282295', 'briefTitle': 'US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety & Immunogenicity of a Booster Dose of dTPa Vaccine (Boostrix®) Co-admnd. With Aventis Pasteur's Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Vaccine (Menactra™) vs Admn. of Either Vaccine Alone in Healthy Adolescents", 'orgStudyIdInfo': {'id': '105753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boostrix + Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.', 'interventionNames': ['Biological: Boostrix®', 'Biological: Menactra™']}, {'type': 'EXPERIMENTAL', 'label': 'Boostrix-Menactra Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.', 'interventionNames': ['Biological: Boostrix®', 'Biological: Menactra™']}, {'type': 'EXPERIMENTAL', 'label': 'Menactra-Boostrix Group', 'description': 'Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.', 'interventionNames': ['Biological: Boostrix®', 'Biological: Menactra™']}], 'interventions': [{'name': 'Boostrix®', 'type': 'BIOLOGICAL', 'description': "GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.", 'armGroupLabels': ['Boostrix + Menactra Group', 'Boostrix-Menactra Group', 'Menactra-Boostrix Group']}, {'name': 'Menactra™', 'type': 'BIOLOGICAL', 'description': "Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.", 'armGroupLabels': ['Boostrix + Menactra Group', 'Boostrix-Menactra Group', 'Menactra-Boostrix Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 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States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '68178', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08889', 'city': 'Whitehouse Station', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.61538, 'lon': -74.77044}}, {'zip': '14534', 'city': 'Pittsford', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.09062, 'lon': -77.515}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44308-1062', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44118', 'city': 'University Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.49783, 'lon': -81.53735}}, {'zip': '16505', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '16508', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '16125', 'city': 'Greenville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4045, 'lon': -80.39118}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15227', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84084', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], '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'}}}}