Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04490018
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2020-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D011054', 'term': 'Poliovirus Vaccine, Inactivated'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D015164', 'term': 'Vaccines, Inactivated'}, {'id': 'D023321', 'term': 'Poliovirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3', 'description': 'SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 153, 'seriousNumAtRisk': 171, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 151, 'seriousNumAtRisk': 171, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 112, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 35, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 30, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 320, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 329, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 261, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 30, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 30, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 86, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 58, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pyrexia', 'notes': 'Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 118, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 114, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 67, 'numAffected': 67}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'notes': 'Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 98, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 87, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 52, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Type 1 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '99.3'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '87.3', 'upperLimit': '96.1'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '90.4', 'upperLimit': '97.8'}]}]}, {'title': 'Serogroup W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.8'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '94.6', 'upperLimit': '99.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.98', 'ciLowerLimit': '0.06', 'ciUpperLimit': '10.36', 'groupDescription': 'Serogroup A', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater than (\\>) -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.97', 'ciLowerLimit': '1.58', 'ciUpperLimit': '9.50', 'groupDescription': 'Serogroup C', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '4.42', 'groupDescription': 'Serogroup W', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '-1.88', 'ciUpperLimit': '4.77', 'groupDescription': 'Serogroup Y', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 31 (post-vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on hSBA Per-Protocol Analysis Set for meningococcal vaccines (PPASM) which was a subset that included all participants who received a dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPASM. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Serogroup A: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.95', 'groupId': 'OG000', 'lowerLimit': '6.18', 'upperLimit': '7.83'}, {'value': '6.41', 'groupId': 'OG001', 'lowerLimit': '5.67', 'upperLimit': '7.26'}, {'value': '7.38', 'groupId': 'OG002', 'lowerLimit': '6.23', 'upperLimit': '8.75'}]}]}, {'title': 'Serogroup A: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '64.6', 'upperLimit': '94.7'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '44.0', 'upperLimit': '71.2'}, {'value': '42.2', 'groupId': 'OG002', 'lowerLimit': '32.5', 'upperLimit': '54.7'}]}]}, {'title': 'Serogroup C: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.40', 'groupId': 'OG000', 'lowerLimit': '5.17', 'upperLimit': '7.92'}, {'value': '5.51', 'groupId': 'OG001', 'lowerLimit': '4.59', 'upperLimit': '6.62'}, {'value': '5.67', 'groupId': 'OG002', 'lowerLimit': '4.51', 'upperLimit': '7.14'}]}]}, {'title': 'Serogroup C: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2294', 'groupId': 'OG000', 'lowerLimit': '1675', 'upperLimit': '3142'}, {'value': '619', 'groupId': 'OG001', 'lowerLimit': '411', 'upperLimit': '931'}, {'value': '1938', 'groupId': 'OG002', 'lowerLimit': '1365', 'upperLimit': '2752'}]}]}, {'title': 'Serogroup Y: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.56', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '2.89'}, {'value': '3.14', 'groupId': 'OG001', 'lowerLimit': '2.63', 'upperLimit': '3.75'}, {'value': '2.43', 'groupId': 'OG002', 'lowerLimit': '2.09', 'upperLimit': '2.84'}]}]}, {'title': 'Serogroup Y: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '202'}, {'value': '84.8', 'groupId': 'OG001', 'lowerLimit': '68.3', 'upperLimit': '105'}, {'value': '171', 'groupId': 'OG002', 'lowerLimit': '138', 'upperLimit': '211'}]}]}, {'title': 'Serogroup W: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.76', 'groupId': 'OG000', 'lowerLimit': '3.22', 'upperLimit': '4.40'}, {'value': '4.36', 'groupId': 'OG001', 'lowerLimit': '3.68', 'upperLimit': '5.17'}, {'value': '3.98', 'groupId': 'OG002', 'lowerLimit': '3.18', 'upperLimit': '4.96'}]}]}, {'title': 'Serogroup W: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '164'}, {'value': '64.6', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': '79.4'}, {'value': '74.6', 'groupId': 'OG002', 'lowerLimit': '61.8', 'upperLimit': '90.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMTs against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Serogroup A: >= 1:4: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '97.4'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '82.1', 'upperLimit': '92.7'}, {'value': '83.9', 'groupId': 'OG002', 'lowerLimit': '75.8', 'upperLimit': '90.2'}]}]}, {'title': 'Serogroup A: >= 1:8: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '64.2'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '42.6', 'upperLimit': '58.6'}, {'value': '58.9', 'groupId': 'OG002', 'lowerLimit': '49.2', 'upperLimit': '68.1'}]}]}, {'title': 'Serogroup A: >= 1:4: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.8'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '90.4', 'upperLimit': '97.8'}, {'value': '96.5', 'groupId': 'OG002', 'lowerLimit': '91.2', 'upperLimit': '99.0'}]}]}, {'title': 'Serogroup A: >= 1:8: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '99.3'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '87.3', 'upperLimit': '96.1'}, {'value': '91.2', 'groupId': 'OG002', 'lowerLimit': '84.3', 'upperLimit': '95.7'}]}]}, {'title': 'Serogroup C: >= 1:4: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '69.0'}, {'value': '61.3', 'groupId': 'OG001', 'lowerLimit': '53.2', 'upperLimit': '68.8'}, {'value': '57.5', 'groupId': 'OG002', 'lowerLimit': '47.9', 'upperLimit': '66.8'}]}]}, {'title': 'Serogroup C: >= 1:8: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '49.2'}, {'value': '35.6', 'groupId': 'OG001', 'lowerLimit': '28.2', 'upperLimit': '43.6'}, {'value': '41.6', 'groupId': 'OG002', 'lowerLimit': '32.4', 'upperLimit': '51.2'}]}]}, {'title': 'Serogroup C: >= 1:4: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '96.3', 'groupId': 'OG001', 'lowerLimit': '92.1', 'upperLimit': '98.6'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '100'}]}]}, {'title': 'Serogroup C: >= 1:8: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '90.4', 'upperLimit': '97.8'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '100'}]}]}, {'title': 'Serogroup Y: >= 1:4: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '20.9'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '24.1'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '15.7'}]}]}, {'title': 'Serogroup Y: >= 1:8: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '15.1'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '22.1'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '12.3'}]}]}, {'title': 'Serogroup Y: >= 1:4: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.8'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'Serogroup Y: >= 1:8: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '94.6', 'upperLimit': '99.6'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W: >= 1:4: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '32.0', 'upperLimit': '47.7'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '38.7', 'upperLimit': '54.6'}, {'value': '30.4', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '39.8'}]}]}, {'title': 'Serogroup W: >= 1:8: Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '29.9'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '36.2'}, {'value': '26.8', 'groupId': 'OG002', 'lowerLimit': '18.9', 'upperLimit': '36.0'}]}]}, {'title': 'Serogroup W: >= 1:4: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.8'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W: >= 1:8: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.8'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Percentage of participants With hSBA antibody titers \\>=1:4 and \\>=1:8 for serogroups A, C, Y, and W were reported in the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '81.9', 'upperLimit': '92.6'}, {'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '68.7', 'upperLimit': '82.5'}, {'value': '65.2', 'groupId': 'OG002', 'lowerLimit': '55.6', 'upperLimit': '73.9'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100'}, {'value': '91.9', 'groupId': 'OG001', 'lowerLimit': '86.5', 'upperLimit': '95.6'}, {'value': '97.3', 'groupId': 'OG002', 'lowerLimit': '92.4', 'upperLimit': '99.4'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.8'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '87.3', 'upperLimit': '96.1'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '97.4'}, {'value': '88.2', 'groupId': 'OG001', 'lowerLimit': '82.2', 'upperLimit': '92.7'}, {'value': '86.6', 'groupId': 'OG002', 'lowerLimit': '78.9', 'upperLimit': '92.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Day 01) to Day 31 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Fold-rise was calculated as ratio of post-dose titer on Day 31 to pre-dose titer on Day 01.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '81.9', 'upperLimit': '92.6'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '81.9'}, {'value': '63.4', 'groupId': 'OG002', 'lowerLimit': '53.8', 'upperLimit': '72.3'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100'}, {'value': '88.8', 'groupId': 'OG001', 'lowerLimit': '82.8', 'upperLimit': '93.2'}, {'value': '97.3', 'groupId': 'OG002', 'lowerLimit': '92.4', 'upperLimit': '99.4'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.8'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '82.1', 'upperLimit': '92.7'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '96.5'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '74.5', 'upperLimit': '87.1'}, {'value': '85.7', 'groupId': 'OG002', 'lowerLimit': '77.8', 'upperLimit': '91.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 31 (post-vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\\<) 1:8, or a \\>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>= 1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.30', 'groupId': 'OG000', 'lowerLimit': '5.64', 'upperLimit': '9.45'}, {'value': '7.06', 'groupId': 'OG001', 'lowerLimit': '5.57', 'upperLimit': '8.95'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4222', 'groupId': 'OG000', 'lowerLimit': '3166', 'upperLimit': '5632'}, {'value': '2361', 'groupId': 'OG001', 'lowerLimit': '1740', 'upperLimit': '3204'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMTs against meningococcal Serogroup C in MenC primed participants (participants who received monovalent MenC priming in infancy \\< 2 years of age) were measured by hSBA. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on participants who were MenC primed, received a dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded. Here, 'number analyzed' = participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Day 01', 'categories': [{'measurements': [{'value': '6.51', 'groupId': 'OG000', 'lowerLimit': '3.56', 'upperLimit': '11.9'}, {'value': '3.32', 'groupId': 'OG001', 'lowerLimit': '2.24', 'upperLimit': '4.91'}]}]}, {'title': 'Day 31', 'categories': [{'measurements': [{'value': '19760', 'groupId': 'OG000', 'lowerLimit': '13308', 'upperLimit': '29338'}, {'value': '7052', 'groupId': 'OG001', 'lowerLimit': '4706', 'upperLimit': '10567'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMTs against Serogroup C in MenC primed participants (participants who received monovalent MenC priming in infancy \\< 2 years of age) were measured by rSBA. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on participants who were MenC primed. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Anti-Tetanus: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '29.5'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '21.5'}]}]}, {'title': 'Anti-Tetanus: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '20.1'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '18.5'}]}]}, {'title': 'Anti-Diphteria: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.200', 'groupId': 'OG000', 'lowerLimit': '0.169', 'upperLimit': '0.238'}, {'value': '0.215', 'groupId': 'OG001', 'lowerLimit': '0.181', 'upperLimit': '0.254'}]}]}, {'title': 'Anti-Diphteria: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.75', 'groupId': 'OG000', 'lowerLimit': '3.24', 'upperLimit': '4.35'}, {'value': '3.88', 'groupId': 'OG001', 'lowerLimit': '3.37', 'upperLimit': '4.47'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Geometric mean concentrations of anti-Diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.', 'unitOfMeasure': 'International units/milliliter (IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis performed on Per-Protocol Analysis Set for concomitant vaccines (PPASC) which was a subset that included all participants who received a dose of study vaccine and had a valid post-vaccination serology result. Participants who presented protocol deviations and who did not produce a valid test result were excluded from PPASC. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Anti-Polio type 1: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000', 'lowerLimit': '75.5', 'upperLimit': '119'}, {'value': '109', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '138'}]}]}, {'title': 'Anti-Polio type 1: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3135', 'groupId': 'OG000', 'lowerLimit': '2692', 'upperLimit': '3650'}, {'value': '3266', 'groupId': 'OG001', 'lowerLimit': '2778', 'upperLimit': '3840'}]}]}, {'title': 'Anti-Polio type 2: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000', 'lowerLimit': '184', 'upperLimit': '281'}, {'value': '234', 'groupId': 'OG001', 'lowerLimit': '188', 'upperLimit': '292'}]}]}, {'title': 'Anti-Polio type 2: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3344', 'groupId': 'OG000', 'lowerLimit': '2635', 'upperLimit': '4245'}, {'value': '2648', 'groupId': 'OG001', 'lowerLimit': '2074', 'upperLimit': '3381'}]}]}, {'title': 'Anti-Polio type 3: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '174'}, {'value': '155', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': '200'}]}]}, {'title': 'Anti-Polio type 3: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7059', 'groupId': 'OG000', 'lowerLimit': '5861', 'upperLimit': '8502'}, {'value': '5591', 'groupId': 'OG001', 'lowerLimit': '4647', 'upperLimit': '6728'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for participants at Day 31 and at Day 61, respectively.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Anti-PT: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '13.8'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '14.4'}]}]}, {'title': 'Anti-PT: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.4', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '67.4'}, {'value': '59.3', 'groupId': 'OG001', 'lowerLimit': '51.1', 'upperLimit': '68.8'}]}]}, {'title': 'Anti-FHA: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '40.9', 'upperLimit': '54.7'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '51.4', 'upperLimit': '66.1'}]}]}, {'title': 'Anti-FHA: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000', 'lowerLimit': '156', 'upperLimit': '200'}, {'value': '210', 'groupId': 'OG001', 'lowerLimit': '187', 'upperLimit': '236'}]}]}, {'title': 'Anti-PRN: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '18.8'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '23.7'}]}]}, {'title': 'Anti-PRN: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '331', 'groupId': 'OG000', 'lowerLimit': '265', 'upperLimit': '414'}, {'value': '394', 'groupId': 'OG001', 'lowerLimit': '316', 'upperLimit': '491'}]}]}, {'title': 'Anti-FIM: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000', 'lowerLimit': '2.23', 'upperLimit': '3.37'}, {'value': '3.18', 'groupId': 'OG001', 'lowerLimit': '2.56', 'upperLimit': '3.95'}]}]}, {'title': 'Anti-FIM: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '207'}, {'value': '194', 'groupId': 'OG001', 'lowerLimit': '140', 'upperLimit': '271'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'GMCs of anti-pertussis antibodies (pertussis toxoid \\[PT\\], filamentous hemagglutinin \\[FHA\\], pertactin \\[PRN\\]) and fimbriae types 2 and 3 \\[FIM\\], were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.', 'unitOfMeasure': 'Endotoxin units per milliliter (EU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-Tetanus: Day 01', 'categories': [{'measurements': [{'value': '0.708', 'groupId': 'OG000', 'lowerLimit': '0.574', 'upperLimit': '0.874'}]}]}, {'title': 'Anti-Tetanus: Day 31', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '30.1', 'upperLimit': '39.6'}]}]}, {'title': 'Anti-Diphtheria: Day 01', 'categories': [{'measurements': [{'value': '0.256', 'groupId': 'OG000', 'lowerLimit': '0.208', 'upperLimit': '0.316'}]}]}, {'title': 'Anti-Diphtheria: Day 31', 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG000', 'lowerLimit': '2.46', 'upperLimit': '3.44'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMCs of anti-diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPASC.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-Polio type 1: Day 01', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '190'}]}]}, {'title': 'Anti-Polio type 1: Day 31', 'categories': [{'measurements': [{'value': '1593', 'groupId': 'OG000', 'lowerLimit': '1306', 'upperLimit': '1943'}]}]}, {'title': 'Anti-Polio type 2: Day 01', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000', 'lowerLimit': '178', 'upperLimit': '285'}]}]}, {'title': 'Anti-Polio type 2: Day 31', 'categories': [{'measurements': [{'value': '2950', 'groupId': 'OG000', 'lowerLimit': '2409', 'upperLimit': '3613'}]}]}, {'title': 'Anti-Polio type 3: Day 01', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': '302'}]}]}, {'title': 'Anti-Polio type 3: Day 31', 'categories': [{'measurements': [{'value': '3166', 'groupId': 'OG000', 'lowerLimit': '2553', 'upperLimit': '3926'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for participants at Day 01 and at Day 31, respectively.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPASC.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-PT: Day 01', 'categories': [{'measurements': [{'value': '8.77', 'groupId': 'OG000', 'lowerLimit': '7.07', 'upperLimit': '10.9'}]}]}, {'title': 'Anti-PT: Day 31', 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '47.4'}]}]}, {'title': 'Anti-FHA: Day 01', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '37.5', 'upperLimit': '52.9'}]}]}, {'title': 'Anti-FHA: Day 31', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000', 'lowerLimit': '128', 'upperLimit': '166'}]}]}, {'title': 'Anti-PRN: Day 01', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '8.40', 'upperLimit': '15.6'}]}]}, {'title': 'Anti-PRN: Day 31', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000', 'lowerLimit': '184', 'upperLimit': '303'}]}]}, {'title': 'Anti-FIM: Day 01', 'categories': [{'measurements': [{'value': '2.32', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '2.94'}]}]}, {'title': 'Anti-FIM: Day 31', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '149'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMCs of anti-pertussis antibodies (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPASC.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Anti-Tetanus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.677', 'groupId': 'OG000', 'lowerLimit': '0.646', 'upperLimit': '0.710'}, {'value': '0.876', 'groupId': 'OG001', 'lowerLimit': '0.824', 'upperLimit': '0.931'}]}]}, {'title': 'Anti-Diphtheria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '22.5'}, {'value': '18.1', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '21.7'}]}]}, {'title': 'Anti-Polio type 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '44.2'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '39.4'}]}]}, {'title': 'Anti-Polio type 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '20.5'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '8.09', 'upperLimit': '15.8'}]}]}, {'title': 'Anti-Polio type 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '38.0', 'upperLimit': '70.5'}, {'value': '36.1', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '48.8'}]}]}, {'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.90', 'groupId': 'OG000', 'lowerLimit': '4.36', 'upperLimit': '5.51'}, {'value': '4.83', 'groupId': 'OG001', 'lowerLimit': '4.33', 'upperLimit': '5.38'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.76', 'groupId': 'OG000', 'lowerLimit': '3.24', 'upperLimit': '4.35'}, {'value': '3.61', 'groupId': 'OG001', 'lowerLimit': '3.18', 'upperLimit': '4.09'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '27.9'}, {'value': '21.6', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '27.7'}]}]}, {'title': 'Anti-FIM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '68.9'}, {'value': '61.2', 'groupId': 'OG001', 'lowerLimit': '49.4', 'upperLimit': '75.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. GMCRs were calculated as the ratio of GMCs at Day 61 and Day 31. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPASC. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-Tetanus', 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '59.3'}]}]}, {'title': 'Anti-Diphtheria', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '9.17', 'upperLimit': '14.1'}]}]}, {'title': 'Anti-Polio type 1', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '7.77', 'upperLimit': '15.4'}]}]}, {'title': 'Anti-Polio type 2', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '9.66', 'upperLimit': '17.8'}]}]}, {'title': 'Anti-Polio type 3', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '20.3'}]}]}, {'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '4.72', 'groupId': 'OG000', 'lowerLimit': '4.05', 'upperLimit': '5.49'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '3.27', 'groupId': 'OG000', 'lowerLimit': '2.82', 'upperLimit': '3.80'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '27.1'}]}]}, {'title': 'Anti-FIM', 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '35.7', 'upperLimit': '58.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. GMCRs were calculated as the ratio of GMCs at Day 31/Day 01. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPASC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Anti-T: Day 31: >=0.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100'}]}]}, {'title': 'Anti-T: Day 31: >=1.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '99.6'}]}]}, {'title': 'Anti-T: Day 61: >=0.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100'}]}]}, {'title': 'Anti-T: Day 61: >=1.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100'}]}]}, {'title': 'Anti-D: Day 31: >=0.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '83.4'}, {'value': '79.6', 'groupId': 'OG001', 'lowerLimit': '72.2', 'upperLimit': '85.8'}]}]}, {'title': 'Anti-D: Day 31: >=1.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '9.6'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '9.6'}]}]}, {'title': 'Anti-D: Day 61: >=0.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100'}]}]}, {'title': 'Anti-D: Day 61: >=1.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '96.7'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '96.2'}]}]}, {'title': 'Anti-Polio 1: Day 31: >=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '98.1'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '90.4', 'upperLimit': '98.1'}]}]}, {'title': 'Anti-Polio 1: Day 61: >=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100'}]}]}, {'title': 'Anti-Polio 2: Day 31: >=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100'}]}]}, {'title': 'Anti-Polio 2: Day 61: >=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100'}]}]}, {'title': 'Anti-Polio 3: Day 31: >=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '98.5'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.2', 'upperLimit': '98.9'}]}]}, {'title': 'Anti-Polio 3: Day 61: >=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers \\>= 0.1 IU/mL, and \\>= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers \\>= 8 (1/dilution). Blood samples were assessed for participants at Day 31 and at Day 61, respectively.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPASC. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-T: Day 01: >=0.1', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000', 'lowerLimit': '91.2', 'upperLimit': '99.0'}]}]}, {'title': 'Anti-T: Day 01: >=1.0', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '48.6'}]}]}, {'title': 'Anti-T: Day 31: >=0.1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'Anti-T: Day 31: >=1.0', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'Anti-D: Day 01: >=0.1', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '77.0', 'upperLimit': '91.0'}]}]}, {'title': 'Anti-D: Day 01: >=1.0', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '16.8'}]}]}, {'title': 'Anti-D: Day 31: >=0.1', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '100'}]}]}, {'title': 'Anti-D: Day 31: >=1.0', 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '95.0'}]}]}, {'title': 'Anti-Polio 1: Day 01: >=8', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '100'}]}]}, {'title': 'Anti-Polio 1: Day 31: >=8', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'Anti-Polio 2: Day 01: >=8', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'Anti-Polio 2: Day 31: >=8', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'Anti-Polio 3: Day 01: >=8', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000', 'lowerLimit': '91.2', 'upperLimit': '99.0'}]}]}, {'title': 'Anti-Polio 3: Day 31: >=8', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers \\>= 0.1 IU/mL, and \\>= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers \\>= 8 (1/dilution). Blood samples were assessed for participants at Day 01 and at Day 31, respectively.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPASC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '74.1', 'upperLimit': '87.4'}, {'value': '83.0', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '88.7'}, {'value': '76.1', 'groupId': 'OG002', 'lowerLimit': '67.2', 'upperLimit': '83.6'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.8', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '81.6'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '68.5', 'upperLimit': '82.8'}, {'value': '70.8', 'groupId': 'OG002', 'lowerLimit': '61.5', 'upperLimit': '79.0'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '99.6'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '89.6', 'upperLimit': '97.6'}, {'value': '91.2', 'groupId': 'OG002', 'lowerLimit': '84.3', 'upperLimit': '95.7'}]}]}, {'title': 'Anti-FIM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '97.2'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '93.2', 'upperLimit': '99.3'}, {'value': '95.6', 'groupId': 'OG002', 'lowerLimit': '90.0', 'upperLimit': '98.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)', 'description': 'Vaccine seroresponse was defined as post-vaccination concentration \\>= 4 \\* Baseline concentration, if the anti-pertussis antibody concentration at Baseline was \\< 4\\*lower limit of quantification (LLOQ), or \\>= 2\\*Baseline concentration, if the anti-pertussis antibody concentration at Baseline was \\>= 4\\*LLOQ. Post vaccine seroresponse for anti-pertussis antigens was Day 31 for Group 3 and Day 61 for Groups 1 and 2.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Anti-HPV type-6: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '1.94', 'upperLimit': '2.73'}, {'value': '2.03', 'groupId': 'OG001', 'lowerLimit': '1.74', 'upperLimit': '2.37'}]}]}, {'title': 'Anti-HPV type-6: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '64.3', 'upperLimit': '85.0'}, {'value': '64.8', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '75.4'}]}]}, {'title': 'Anti-HPV type-11: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.11', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '1.18'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.13'}]}]}, {'title': 'Anti-HPV type-11: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000', 'lowerLimit': '38.9', 'upperLimit': '49.5'}, {'value': '39.3', 'groupId': 'OG001', 'lowerLimit': '33.9', 'upperLimit': '45.5'}]}]}, {'title': 'Anti-HPV type-16: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.06', 'groupId': 'OG000', 'lowerLimit': '1.95', 'upperLimit': '2.17'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '2.19'}]}]}, {'title': 'Anti-HPV type-16: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000', 'lowerLimit': '171', 'upperLimit': '231'}, {'value': '168', 'groupId': 'OG001', 'lowerLimit': '142', 'upperLimit': '199'}]}]}, {'title': 'Anti-HPV type-18: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '1.70'}, {'value': '1.52', 'groupId': 'OG001', 'lowerLimit': '1.49', 'upperLimit': '1.54'}]}]}, {'title': 'Anti-HPV type-18: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '56.4'}, {'value': '38.5', 'groupId': 'OG001', 'lowerLimit': '31.3', 'upperLimit': '47.4'}]}]}, {'title': 'Anti-HPV type-31: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.995', 'upperLimit': '1.18'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '1.01', 'upperLimit': '1.10'}]}]}, {'title': 'Anti-HPV type-31: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '38.1'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '34.9'}]}]}, {'title': 'Anti-HPV type-33: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.987', 'upperLimit': '1.04'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '0.997', 'upperLimit': '1.04'}]}]}, {'title': 'Anti-HPV type-33: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '24.9'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '22.7'}]}]}, {'title': 'Anti-HPV type-45: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.520', 'groupId': 'OG000', 'lowerLimit': '0.499', 'upperLimit': '0.543'}, {'value': '0.509', 'groupId': 'OG001', 'lowerLimit': '0.492', 'upperLimit': '0.527'}]}]}, {'title': 'Anti-HPV type-45: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '9.35', 'upperLimit': '14.1'}, {'value': '9.54', 'groupId': 'OG001', 'lowerLimit': '7.68', 'upperLimit': '11.9'}]}]}, {'title': 'Anti-HPV type-52: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.535', 'groupId': 'OG000', 'lowerLimit': '0.503', 'upperLimit': '0.569'}, {'value': '0.514', 'groupId': 'OG001', 'lowerLimit': '0.498', 'upperLimit': '0.530'}]}]}, {'title': 'Anti-HPV type-52: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '41.1', 'upperLimit': '54.7'}, {'value': '39.3', 'groupId': 'OG001', 'lowerLimit': '33.5', 'upperLimit': '46.1'}]}]}, {'title': 'Anti-HPV type-58: Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.16'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.10'}]}]}, {'title': 'Anti-HPV type-58: Day 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000', 'lowerLimit': '25.5', 'upperLimit': '34.3'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '22.2', 'upperLimit': '30.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-HPV type-6: Day 01', 'categories': [{'measurements': [{'value': '2.12', 'groupId': 'OG000', 'lowerLimit': '1.76', 'upperLimit': '2.55'}]}]}, {'title': 'Anti-HPV type-6: Day 31', 'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000', 'lowerLimit': '42.0', 'upperLimit': '60.9'}]}]}, {'title': 'Anti-HPV type-11: Day 01', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.13'}]}]}, {'title': 'Anti-HPV type-11: Day 31', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '42.8'}]}]}, {'title': 'Anti-HPV type-16: Day 01', 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '2.07'}]}]}, {'title': 'Anti-HPV type-16: Day 31', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000', 'lowerLimit': '118', 'upperLimit': '179'}]}]}, {'title': 'Anti-HPV type-18: Day 01', 'categories': [{'measurements': [{'value': '1.50', 'comment': 'The 95% CI was not computable as the standard deviation of the sample was 0, since all participants had the same value.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Anti-HPV type-18: Day 31', 'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '40.6'}]}]}, {'title': 'Anti-HPV type-31: Day 01', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.13'}]}]}, {'title': 'Anti-HPV type-31: Day 31', 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '31.8'}]}]}, {'title': 'Anti-HPV type-33: Day 01', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.989', 'upperLimit': '1.03'}]}]}, {'title': 'Anti-HPV type-33: Day 31', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '18.6'}]}]}, {'title': 'Anti-HPV type-45: Day 01', 'categories': [{'measurements': [{'value': '0.524', 'groupId': 'OG000', 'lowerLimit': '0.493', 'upperLimit': '0.556'}]}]}, {'title': 'Anti-HPV type-45: Day 31', 'categories': [{'measurements': [{'value': '8.24', 'groupId': 'OG000', 'lowerLimit': '6.30', 'upperLimit': '10.8'}]}]}, {'title': 'Anti-HPV type-52: Day 01', 'categories': [{'measurements': [{'value': '0.521', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '0.544'}]}]}, {'title': 'Anti-HPV type-52: Day 31', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '33.5', 'upperLimit': '49.8'}]}]}, {'title': 'Anti-HPV type-58: Day 01', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.14'}]}]}, {'title': 'Anti-HPV type-58: Day 31', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '25.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPASC.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}], 'classes': [{'title': 'Anti-HPV type-6', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '38.6'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '38.5'}]}]}, {'title': 'Anti-HPV type-11', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '34.2', 'upperLimit': '44.5'}, {'value': '36.5', 'groupId': 'OG001', 'lowerLimit': '31.3', 'upperLimit': '42.7'}]}]}, {'title': 'Anti-HPV type-16', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000', 'lowerLimit': '83.4', 'upperLimit': '112'}, {'value': '80.8', 'groupId': 'OG001', 'lowerLimit': '68.1', 'upperLimit': '95.8'}]}]}, {'title': 'Anti-HPV type-18', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '36.2'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '31.2'}]}]}, {'title': 'Anti-HPV type-31', 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '35.4'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '22.8', 'upperLimit': '33.2'}]}]}, {'title': 'Anti-HPV type-33', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '24.4'}, {'value': '18.7', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '22.2'}]}]}, {'title': 'Anti-HPV type-45', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '26.9'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '23.3'}]}]}, {'title': 'Anti-HPV type-52', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '77.1', 'upperLimit': '100'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '65.0', 'upperLimit': '90.1'}]}]}, {'title': 'Anti-HPV type-58', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '23.3', 'upperLimit': '31.4'}, {'value': '24.8', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '29.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 61/Day 31. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPASC. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-HPV type-6', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '29.3'}]}]}, {'title': 'Anti-HPV type-11', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000', 'lowerLimit': '28.6', 'upperLimit': '40.1'}]}]}, {'title': 'Anti-HPV type-16', 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000', 'lowerLimit': '58.6', 'upperLimit': '88.2'}]}]}, {'title': 'Anti-HPV type-18', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '27.1'}]}]}, {'title': 'Anti-HPV type-31', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '29.6'}]}]}, {'title': 'Anti-HPV type-33', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '18.4'}]}]}, {'title': 'Anti-HPV type-45', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '20.7'}]}]}, {'title': 'Anti-HPV type-52', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '64.3', 'upperLimit': '95.5'}]}]}, {'title': 'Anti-HPV type-58', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '23.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 31/Day 01. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPASC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Anti-HPV type-6', 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '92.6'}, {'value': '88.4', 'groupId': 'OG001', 'lowerLimit': '82.1', 'upperLimit': '93.1'}, {'value': '85.0', 'groupId': 'OG002', 'lowerLimit': '77.0', 'upperLimit': '91.0'}]}]}, {'title': 'Anti-HPV type-11', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '93.2', 'upperLimit': '99.3'}, {'value': '97.3', 'groupId': 'OG002', 'lowerLimit': '92.4', 'upperLimit': '99.4'}]}]}, {'title': 'Anti-HPV type-16', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '92.2', 'upperLimit': '98.9'}, {'value': '98.2', 'groupId': 'OG002', 'lowerLimit': '93.8', 'upperLimit': '99.8'}]}]}, {'title': 'Anti-HPV type-18', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '89.6', 'upperLimit': '97.6'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '96.2'}, {'value': '88.5', 'groupId': 'OG002', 'lowerLimit': '81.1', 'upperLimit': '93.7'}]}]}, {'title': 'Anti-HPV type-31', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000', 'lowerLimit': '92.2', 'upperLimit': '98.9'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '87.8', 'upperLimit': '96.7'}, {'value': '88.5', 'groupId': 'OG002', 'lowerLimit': '81.1', 'upperLimit': '93.7'}]}]}, {'title': 'Anti-HPV type-33', 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '98.1'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '95.7'}, {'value': '87.6', 'groupId': 'OG002', 'lowerLimit': '80.1', 'upperLimit': '93.1'}]}]}, {'title': 'Anti-HPV type-45', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '87.5'}, {'value': '83.0', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '88.7'}, {'value': '75.2', 'groupId': 'OG002', 'lowerLimit': '66.2', 'upperLimit': '82.9'}]}]}, {'title': 'Anti-HPV type-52', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '99.6'}, {'value': '96.5', 'groupId': 'OG002', 'lowerLimit': '91.2', 'upperLimit': '99.0'}]}]}, {'title': 'Anti-HPV type-58', 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '98.1'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '96.2'}, {'value': '92.0', 'groupId': 'OG002', 'lowerLimit': '85.4', 'upperLimit': '96.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)', 'description': 'Vaccine Seroconversion was defined as changing serostatus from seronegative (participants with a titer inferior to the serostatus cut-off value) at Baseline to seropositive after vaccination. A participant with a titer at or above the serostatus cut-off for a given HPV type was considered seropositive for that type. The serostatus cut-offs for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were 9, 6, 5, 5, 3, 4, 3, 5 and 5 milli-Merck units (mMU)/mL, respectively. Post vaccine seroconversion for antigens contained in HPV vaccine was Day 31 for Group 3 and Day 61 for Groups 1 and 2.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPASC. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 minutes post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])', 'description': 'An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Reported AEs for each arm were presented as pre-specified in the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set that included all participants who had received at least one dose of the study vaccines and had any safety data available. Here, \'number analyzed\' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccine (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'MenACYW Conjugate vaccine: Pain: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': 'MenACYW Conjugate vaccine: Erythema: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'MenACYW Conjugate vaccine: Swelling: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Nimenrix vaccine: Pain: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Nimenrix vaccine: Erythema: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Nimenrix vaccine: Swelling: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG001'}]}]}, {'title': '9vHPV: Pain: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': '9vHPV: Erythema: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '9vHPV: Swelling: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Tdap-IPV: Pain: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Tdap-IPV: Erythema: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Tdap-IPV: Swelling: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'MenACYW Conjugate vaccine: Pain: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': 'MenACYW Conjugate vaccine: Erythema: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'MenACYW Conjugate vaccine: Swelling: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Nimenrix vaccine: Pain: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Nimenrix vaccine: Erythema: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Nimenrix vaccine: Swelling: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG001'}]}]}, {'title': '9vHPV: Pain: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG002'}]}]}, {'title': '9vHPV: Erythema: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG002'}]}]}, {'title': '9vHPV: Swelling: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Tdap-IPV: Pain: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Tdap-IPV: Erythema: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Tdap-IPV: Swelling: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'MenACYW Conjugate vaccine: Pain: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MenACYW Conjugate vaccine: Erythema: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MenACYW Conjugate vaccine: Swelling: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nimenrix vaccine: Pain: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nimenrix vaccine: Erythema: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nimenrix vaccine: Swelling: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '9vHPV: Pain: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}, {'title': '9vHPV: Erythema: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '9vHPV: Swelling: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Tdap-IPV: Pain: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Tdap-IPV: Erythema: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Tdap-IPV: Swelling: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])', 'description': 'SR: expected AR (sign or symptom) observed \\& reported under conditions (nature \\& onset) prelisted (i.e., solicited) in CRF \\& considered as related to product. Injection site reactions: pain, erythema, \\& swelling. Here, "0" in number analyzed for MenACYW categories signifies no participant were evaluable as in Group (Gps.) 2 MenACYW vaccine was not administered; for Gps.1\\& 3: "0" in number analyzed for Nimenrix signifies no participant were evaluable as in Gps. 1 \\& 3 Nimenrix was not administered. At Vaccination (vacc.)1 (Gps.1 \\& 2): "0" in number analyzed for 9vHPV \\& Tadp-IPV signifies no participant were evaluable as these vaccines were not administered at vacc.1 (Day01). At Vacc. 2 (Gps.1, 2 \\& 3): "0" in number analyzed for MenACYW and Nimenrix signifies no participant were evaluable as these vaccines were not administered at vacc. 2 (Day 31); \\& for Gps. 3 "0" in number analyzed for 9vHPV and Tadp-IPV signifies no participant were evaluable as these vaccines were not administered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety analysis set. Here, 'Number analyzed'=participants with available data for specified category. The assessment of injection site reactions (pain, swelling and erythema) after the MenACYW Conjugate vaccines (MenQuadfi and Nimenrix) and 2 other adolescent vaccines allowed in the assessment of local reactogenicity and helped in identifying injection site reaction per vaccine received. Reported AEs for each arm were presented as pre-specified in the study protocol."}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Fever: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Headache: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Malaise: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia: Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Fever: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Headache: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Malaise: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia: Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Fever: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Headache: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Malaise: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia: Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])', 'description': 'A solicited reaction (SR) was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, and myalgia. Reported AEs for each arm were presented as pre-specified in the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set. Here, \'overall number of participants analyzed\' = participants with available data for this outcome measure and \'number analyzed\' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 01 up to Day 31 post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])', 'description': 'An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set. Here, \'Number analyzed\' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 01 up to the last study day (i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3)', 'description': 'A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 milliliters (mL) intramuscular injection of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 01 and 0.5-mL intramuscular injection of 9-valent human papilloma virus (9vHPV) + tetanus, diphtheria, and acellular pertussis - inactivated polio vaccines (Tdap-IPV) (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'FG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'FG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '173'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'Safety Analysis Set', 'comment': 'Participants who had received at least one dose of the study vaccines (all groups) and had any safety data available.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '171'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'Vaccinated at Day 01', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '172'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'Vaccinated at Day 31', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'comment': 'Group 3 participants did not receive any vaccination at Day 31.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 21 active centers in Hungary, Italy, Spain and Singapore between 16 March 2021 to 11 May 2022.', 'preAssignmentDetails': 'A total of 463 participants were enrolled and randomized in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '463', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.'}, {'id': 'BG001', 'title': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.'}, {'id': 'BG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '2.32', 'groupId': 'BG000'}, {'value': '12.8', 'spread': '2.38', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '2.47', 'groupId': 'BG002'}, {'value': '12.6', 'spread': '2.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '449', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-19', 'size': 4141675, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-09T09:07', 'hasProtocol': True}, {'date': '2021-06-24', 'size': 1175840, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-09T09:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study was performed in a partially observer-blind fashion:\n\nIn Groups 1 and 2\n\n* Investigators and study staff who conducted the safety assessment, participants, parents/legally acceptable representatives, the Sponsor, and laboratory personnel performing the serology testing were kept blinded to the vaccine received.\n* Only the study staff who prepared and administered the vaccine and were not involved with the safety evaluation know which vaccine was administered.\n\nIn Group 3\n\n\\- Everyone involved in the study (i.e., Investigator, study staff, the Sponsor, participants, parents/legally acceptable representatives) know which vaccine was administered. This open-label design for Group 3 was due to the different vaccination schedule for this group than for Groups 1 and 2.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a parallel group prevention study with 2 groups that were observer blind (only the person administering the vaccine was unblinded), and 1 group that was open-label.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 463}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2020-07-27', 'resultsFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-05-09', 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2', 'timeFrame': 'Day 31 (post-vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMTs against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Percentage of participants With hSBA antibody titers \\>=1:4 and \\>=1:8 for serogroups A, C, Y, and W were reported in the outcome measure.'}, {'measure': 'Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W', 'timeFrame': 'From Baseline (Day 01) to Day 31 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Fold-rise was calculated as ratio of post-dose titer on Day 31 to pre-dose titer on Day 01.'}, {'measure': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W', 'timeFrame': 'Day 31 (post-vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\\<) 1:8, or a \\>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>= 1:8.'}, {'measure': 'Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMTs against meningococcal Serogroup C in MenC primed participants (participants who received monovalent MenC priming in infancy \\< 2 years of age) were measured by hSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Geometric Mean Titers (GMTs) of Antibodies Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMTs against Serogroup C in MenC primed participants (participants who received monovalent MenC priming in infancy \\< 2 years of age) were measured by rSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Geometric mean concentrations of anti-Diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for participants at Day 31 and at Day 61, respectively.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'GMCs of anti-pertussis antibodies (pertussis toxoid \\[PT\\], filamentous hemagglutinin \\[FHA\\], pertactin \\[PRN\\]) and fimbriae types 2 and 3 \\[FIM\\], were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMCs of anti-diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for participants at Day 01 and at Day 31, respectively.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'GMCs of anti-pertussis antibodies (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.'}, {'measure': 'Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. GMCRs were calculated as the ratio of GMCs at Day 61 and Day 31. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.'}, {'measure': 'Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. GMCRs were calculated as the ratio of GMCs at Day 31/Day 01. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.'}, {'measure': 'Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers \\>= 0.1 IU/mL, and \\>= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers \\>= 8 (1/dilution). Blood samples were assessed for participants at Day 31 and at Day 61, respectively.'}, {'measure': 'Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers \\>= 0.1 IU/mL, and \\>= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers \\>= 8 (1/dilution). Blood samples were assessed for participants at Day 01 and at Day 31, respectively.'}, {'measure': 'Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens', 'timeFrame': 'Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)', 'description': 'Vaccine seroresponse was defined as post-vaccination concentration \\>= 4 \\* Baseline concentration, if the anti-pertussis antibody concentration at Baseline was \\< 4\\*lower limit of quantification (LLOQ), or \\>= 2\\*Baseline concentration, if the anti-pertussis antibody concentration at Baseline was \\>= 4\\*LLOQ. Post vaccine seroresponse for anti-pertussis antigens was Day 31 for Group 3 and Day 61 for Groups 1 and 2.'}, {'measure': 'Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.'}, {'measure': 'Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.'}, {'measure': 'Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2', 'timeFrame': 'Day 31 (post-vaccination) and Day 61 (post-vaccination)', 'description': 'Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 61/Day 31. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.'}, {'measure': 'Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3', 'timeFrame': 'Day 01 (pre-vaccination) and Day 31 (post-vaccination)', 'description': 'Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 31/Day 01. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.'}, {'measure': 'Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine', 'timeFrame': 'Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)', 'description': 'Vaccine Seroconversion was defined as changing serostatus from seronegative (participants with a titer inferior to the serostatus cut-off value) at Baseline to seropositive after vaccination. A participant with a titer at or above the serostatus cut-off for a given HPV type was considered seropositive for that type. The serostatus cut-offs for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were 9, 6, 5, 5, 3, 4, 3, 5 and 5 milli-Merck units (mMU)/mL, respectively. Post vaccine seroconversion for antigens contained in HPV vaccine was Day 31 for Group 3 and Day 61 for Groups 1 and 2.'}, {'measure': 'Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 30 minutes post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])', 'description': 'An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Reported AEs for each arm were presented as pre-specified in the study protocol.'}, {'measure': 'Number of Participants Reporting Solicited Injection Site Reactions', 'timeFrame': 'Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])', 'description': 'SR: expected AR (sign or symptom) observed \\& reported under conditions (nature \\& onset) prelisted (i.e., solicited) in CRF \\& considered as related to product. Injection site reactions: pain, erythema, \\& swelling. Here, "0" in number analyzed for MenACYW categories signifies no participant were evaluable as in Group (Gps.) 2 MenACYW vaccine was not administered; for Gps.1\\& 3: "0" in number analyzed for Nimenrix signifies no participant were evaluable as in Gps. 1 \\& 3 Nimenrix was not administered. At Vaccination (vacc.)1 (Gps.1 \\& 2): "0" in number analyzed for 9vHPV \\& Tadp-IPV signifies no participant were evaluable as these vaccines were not administered at vacc.1 (Day01). At Vacc. 2 (Gps.1, 2 \\& 3): "0" in number analyzed for MenACYW and Nimenrix signifies no participant were evaluable as these vaccines were not administered at vacc. 2 (Day 31); \\& for Gps. 3 "0" in number analyzed for 9vHPV and Tadp-IPV signifies no participant were evaluable as these vaccines were not administered.'}, {'measure': 'Number of Participants Reporting Solicited Systemic Reactions', 'timeFrame': 'Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])', 'description': 'A solicited reaction (SR) was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, and myalgia. Reported AEs for each arm were presented as pre-specified in the study protocol.'}, {'measure': 'Number of Participants Reporting Unsolicited Adverse Events (AEs)', 'timeFrame': 'From Day 01 up to Day 31 post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])', 'description': 'An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.'}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI)', 'timeFrame': 'From Day 01 up to the last study day (i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3)', 'description': 'A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningococcal Immunisation', 'Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '38955966', 'type': 'DERIVED', 'citation': 'Diez-Domingo J, Simko R, Icardi G, Chong CP, Zocchetti C, Syrkina O, Bchir S, Bertrand-Gerentes I. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study. Infect Dis Ther. 2024 Aug;13(8):1835-1859. doi: 10.1007/s40121-024-01009-x. Epub 2024 Jul 2.'}], 'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=25311&tenant=MT_SNY_9011', 'label': 'MEQ00071 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement \\[hSBA\\] titer greater than or equal to \\[\\>=\\] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2).\n\nSecondary Objective:\n\nTo describe:\n\n* the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine \\[adsorbed, reduced antigen(s) content\\] (Tdap-IPV) vaccines (Group 3).\n* the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status.\n* the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination.\n* the safety profile in each group after each and any vaccination.', 'detailedDescription': 'The duration of study participation for each participant was approximately 30 to 60 days, including 2 or 3 visits (1 or 2 vaccination visit) and 1 or 2 telephone calls, depending on study Group.\n\n\\* This was the first dose of 9vHPV, of the 2-dose or 3-dose series according to the local recommendations and age of the participant. These additional vaccinations for the completion of 9vHPV schedule took place outside of the objectives and scope of this study and thus were not described in this protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 10 to 17 years on the day of inclusion ('10 to 17 years' means from the day of the 10th birthday to the day before the 18th birthday).\n* Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants having received monovalent MenC priming in infancy (less than \\[\\<\\] 2 years of age).\n* Assent form had been signed and dated by the participant as per local regulation, and Informed Consent Form had been signed and dated by the parent/legally acceptable representative and by the participant if she/he turns 18 years old during the study.\n* Participants and parent/legally acceptable representative were able to attend all scheduled visits and compiled with all study procedures.\n* Covered by health insurance, if required by local regulations.\n\nExclusion Criteria:\n\n* Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche.\n* Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine), except licensed monovalent MenC vaccination received before 2 years of age.\n* Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.\n* Receipt of any vaccine in the 4 weeks preceding any study vaccination or planned receipt of any vaccine in the 4 weeks following any study vaccination except for influenza vaccination, which might receive at least 2 weeks before study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines.\n* History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio virus vaccine within the previous 3 years.\n* Previous human papilloma virus (HPV) vaccination.\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months.\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.\n* Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection or disease.\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.\n* Personal history of Guillain-Barré syndrome.\n* Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination.\n* Personal history of new or past encephalopathy, progressive or unstable neurological disorder, or unstable epilepsy.\n* Verbal report of thrombocytopenia, contraindicating intramuscular vaccination.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.\n* Current alcohol abuse or drug addiction.\n* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.\n* Moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination or febrile illness (temperature \\>= 38.0 degree Celsius \\[\\>= 100.4 degree Fahrenheit\\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event has subsided.\n* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.\n* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.\n* Participant at high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04490018', 'briefTitle': 'Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly With 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents', 'orgStudyIdInfo': {'id': 'MEQ00071'}, 'secondaryIdInfos': [{'id': '2020-001665-37', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1249-2973', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5-milliliter (mL) intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.', 'interventionNames': ['Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)', 'Biological: Human Papillomavirus 9-valent Vaccine (9vHPV)', 'Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'description': 'Participants received 0.5-mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.', 'interventionNames': ['Biological: Meningococcal group A, C, W-135, and Y conjugate vaccine', 'Biological: Human Papillomavirus 9-valent Vaccine (9vHPV)', 'Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)', 'description': 'Participants received 0.5-mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.', 'interventionNames': ['Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)', 'Biological: Human Papillomavirus 9-valent Vaccine (9vHPV)', 'Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)']}], 'interventions': [{'name': 'Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)', 'type': 'BIOLOGICAL', 'otherNames': ['MenQuadfi®'], 'description': 'Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)']}, {'name': 'Meningococcal group A, C, W-135, and Y conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Nimenrix®'], 'description': 'Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular', 'armGroupLabels': ['Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)']}, {'name': 'Human Papillomavirus 9-valent Vaccine (9vHPV)', 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil® 9'], 'description': 'Pharmaceutical form: Suspension for injection Route of administration: Intramuscular', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)']}, {'name': 'Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)', 'type': 'BIOLOGICAL', 'otherNames': ['Repevax®/Triaxis®/Adacel®Polio'], 'description': 'Pharmaceutical form: Suspension for injection Route of administration: Intramuscular', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)', 'Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1042', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number :3480003', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '9024', 'city': 'Győr', 'country': 'Hungary', 'facility': 'Investigational Site Number :3480001', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '3527', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Investigational Site Number :3480002', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '7900', 'city': 'Szigetvár', 'country': 'Hungary', 'facility': 'Investigational Site Number :3480004', 'geoPoint': {'lat': 46.04865, 'lon': 17.80554}}, {'zip': '7900', 'city': 'Szombathely', 'country': 'Hungary', 'facility': 'Investigational Site Number :3480006', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'zip': '71122', 'city': 'Foggia', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Investigational Site Number :3800005', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '88100', 'city': 'Catanzaro', 'state': 'Calabria', 'country': 'Italy', 'facility': 'Investigational Site Number :3800006', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '20154', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Investigational Site Number :3800002', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '90131', 'city': 'Palermo', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Investigational Site Number :3800004', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': 'IT-16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Investigational Site Number :3800001', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '229899', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Investigational Site Number :7020002', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Investigational Site Number :7240001', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona [Barcelona]', 'country': 'Spain', 'facility': 'Investigational Site Number :7240002', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, 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