Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT03890367
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2019-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C043226', 'term': 'meningococcal group A polysaccharide'}]}}, '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 adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.', 'description': 'Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 197, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group 2: Nimenrix® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 192, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Group 3: NeisVac-C® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.', 'otherNumAtRisk': 239, 'deathsNumAtRisk': 239, 'otherNumAffected': 203, 'seriousNumAtRisk': 239, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 73, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 73, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 82, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 95, 'numAffected': 95}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 95, 'numAffected': 95}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 96, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 73, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 91, 'numAffected': 91}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 41, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 45, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 47, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 59, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 67, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 67, 'numAffected': 67}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 103, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 101, 'numAffected': 101}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 109, 'numAffected': 107}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Respiratory Syncytial Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Foreign Body In Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.4', 'upperLimit': '100'}, {'value': '89.1', 'groupId': 'OG001', 'lowerLimit': '84.1', 'upperLimit': '93.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '10.43', 'ciLowerLimit': '5.68', 'ciUpperLimit': '16.2', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two-sided 97.5 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 97.5% CI of the percentage difference between compared groups was greater than (\\>) -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroup C were measured by hSBA.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on hSBA per-protocol analysis set (PPAS) which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '515', 'groupId': 'OG000', 'lowerLimit': '450', 'upperLimit': '591'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '37.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '16.3', 'ciLowerLimit': '12.7', 'ciUpperLimit': '21.0', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \\>1/1.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C 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 PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.'}, {'type': 'PRIMARY', 'title': 'GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '515', 'groupId': 'OG000', 'lowerLimit': '450', 'upperLimit': '591'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '37.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '16.3', 'ciLowerLimit': '12.7', 'ciUpperLimit': '21.0', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \\>1.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C 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 PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Nimenrix® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.4', 'upperLimit': '100'}, {'value': '89.1', 'groupId': 'OG001', 'lowerLimit': '84.1', 'upperLimit': '93.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '10.43', 'ciLowerLimit': '5.68', 'ciUpperLimit': '16.20', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The superiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \\>0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroup C were measured by hSBA.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 3: NeisVac-C® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.00', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '2.28', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \\>-10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroup C were measured by rSBA.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.'}, {'type': 'PRIMARY', 'title': 'GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 3: NeisVac-C® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '2143', 'groupId': 'OG000', 'lowerLimit': '1870', 'upperLimit': '2456'}, {'value': '1624', 'groupId': 'OG001', 'lowerLimit': '1425', 'upperLimit': '1850'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.32', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.64', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \\>1/1.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C 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 rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.'}, {'type': 'PRIMARY', 'title': 'GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 3: NeisVac-C® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '2143', 'groupId': 'OG000', 'lowerLimit': '1870', 'upperLimit': '2456'}, {'value': '1624', 'groupId': 'OG001', 'lowerLimit': '1425', 'upperLimit': '1850'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.32', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.64', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \\>1.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C 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 rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. 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'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled in 29 active centers in Denmark, Germany and Finland from 12 September 2019 to 03 September 2020.', 'preAssignmentDetails': 'A total of 707 participants were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}, {'value': '707', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'BG001', 'title': 'Group 2: Nimenrix® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.'}, {'id': 'BG002', 'title': 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{'value': '131', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}, {'value': '687', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-15', 'size': 1356625, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-09T11:09', 'hasProtocol': True}, {'date': '2020-12-16', 'size': 629763, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-09T11:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Modified double-blind: the participant (or legally acceptable representative), and the Investigator remained unaware of the treatment assignments throughout the study. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 707}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2019-03-25', 'resultsFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-09-09', 'studyFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroup C were measured by hSBA.'}, {'measure': 'Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C were measured by hSBA. 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Titers were expressed in terms of 1/dilution.'}, {'measure': 'GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C were measured by rSBA. 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Titers were expressed in terms of 1/dilution.'}, {'measure': 'GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'Antibody titers against Meningococcal Serogroup C were measured by hSBA.'}, {'measure': 'GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningococcal Immunisation (Healthy Volunteers)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=25309&tenant=MT_SNY_9011', 'label': 'MEQ00065 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate:\n\n* the non-inferiority of the seroprotection rate (antibody titers greater than or equal to \\[\\>=\\] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority was demonstrated, then\n* the non-inferiority of the antibody response (geometric mean titers \\[GMT\\]). If this non-inferiority was demonstrated, then\n* the superiority of the antibody response (GMT). If this superiority was demonstrated, then\n* the superiority of the seroprotection rate.\n\nOr to demonstrate:\n\n* the non-inferiority of the seroprotection rate (antibody titers \\>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority was demonstrated, then\n* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then\n* the superiority of the antibody response (GMT).\n\nSecondary Objective:\n\nTo demonstrate:\n\n* the non-inferiority of the seroprotection rate (antibody titers \\>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as measured by rSBA. If this non-inferiority was demonstrated, then\n* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then\n* the superiority of the antibody response (GMT).\n\nOr to demonstrate:\n\n* the non-inferiority of the seroprotection rate (antibody titers \\>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority was demonstrated, then\n* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then\n* the superiority of the antibody response (GMT) .', 'detailedDescription': 'Study duration per participant was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.\n\nSafety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events up to 30 days after vaccination, serious adverse events and adverse event of special interest throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Aged 12 to 23 months on the day of the first study visit ("12 to 23 months" means from the 12th month after birth to the day before the 24th month after birth).\n* Informed consent form (ICF) had been signed and dated by the parent(s)/legally acceptable representative(s) and by an independent witness if required by local regulations.\n* Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.\n\nExclusion criteria:\n\n* Participation in the 4 weeks (28 days) preceding the 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 (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at least 2 weeks before or after study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines.\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months.\n* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B vaccine).\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* At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic 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 an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.\n* Personal history of Guillain-Barré syndrome.\n* Thrombocytopenia, as reported by the parent/ legally acceptable representative or suspected thrombocytopenia contraindicating intramuscular vaccination in the Investigator\'s opinion.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator\'s opinion.\n* Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.\n* Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \\>= 38.0 degree Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.\n* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.\n* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.\n\nThe above information was not intended to contain all considerations relevant to a participant\'s potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT03890367', 'briefTitle': 'Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age', 'orgStudyIdInfo': {'id': 'MEQ00065'}, 'secondaryIdInfos': [{'id': '2018-003790-10', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1217-2456', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.', 'interventionNames': ['Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Nimenrix® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.', 'interventionNames': ['Biological: Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3: NeisVac-C® Vaccine', 'description': 'Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.', 'interventionNames': ['Biological: Meningococcal group C polysaccharide Conjugate vaccine adsorbed']}], 'interventions': [{'name': 'Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['MenACYW Conjugate vaccine'], 'description': 'Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine']}, {'name': 'Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Nimenrix®'], 'description': 'Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular', 'armGroupLabels': ['Group 2: Nimenrix® Vaccine']}, {'name': 'Meningococcal group C polysaccharide Conjugate vaccine adsorbed', 'type': 'BIOLOGICAL', 'otherNames': ['NeisVac-C®'], 'description': 'Pharmaceutical form: Suspension for injection Route of administration: Intramuscular', 'armGroupLabels': ['Group 3: NeisVac-C® Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Investigational Site Number 2080001', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Investigational Site Number 2080002', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Investigational Site Number 2080003', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '02230', 'city': 'Espoo', 'country': 'Finland', 'facility': 'Investigational Site Number 2460006', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Investigational Site Number 2460005', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '04400', 'city': 'Järvenpää', 'country': 'Finland', 'facility': 'Investigational Site Number 2460004', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '67100', 'city': 'Kokkola', 'country': 'Finland', 'facility': 'Investigational Site Number 2460008', 'geoPoint': {'lat': 63.83847, 'lon': 23.13066}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Investigational Site Number 2460007', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '28100', 'city': 'Pori', 'country': 'Finland', 'facility': 'Investigational Site Number 2460003', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '60100', 'city': 'Seinäjoki', 'country': 'Finland', 'facility': 'Investigational Site Number 2460010', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Investigational Site Number 2460001', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Investigational Site Number 2460002', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '74357', 'city': 'Bönnigheim', 'country': 'Germany', 'facility': 'Investigational Site Number 2760015', 'geoPoint': {'lat': 49.04018, 'lon': 9.09386}}, {'zip': '49565', 'city': 'Bramsche', 'country': 'Germany', 'facility': 'Investigational Site Number 2760004', 'geoPoint': {'lat': 52.40881, 'lon': 7.97288}}, {'zip': '75015', 'city': 'Bretten', 'country': 'Germany', 'facility': 'Investigational Site Number 2760019', 'geoPoint': {'lat': 49.03685, 'lon': 8.70745}}, {'zip': '99086', 'city': 'Erfurt', 'country': 'Germany', 'facility': 'Investigational Site Number 2760002', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '22415', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site Number 2760017', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '76863', 'city': 'Herxheim', 'country': 'Germany', 'facility': 'Investigational Site Number 2760020', 'geoPoint': {'lat': 49.1463, 'lon': 8.21346}}, {'zip': '50354', 'city': 'Hürth', 'country': 'Germany', 'facility': 'Investigational Site Number 2760007', 'geoPoint': {'lat': 50.87079, 'lon': 6.86761}}, {'zip': '25524', 'city': 'Itzehoe', 'country': 'Germany', 'facility': 'Investigational Site Number 2760013', 'geoPoint': {'lat': 53.92099, 'lon': 9.51529}}, {'zip': '68161', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Investigational Site Number 2760011', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '41236', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Investigational Site Number 2760003', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '41236', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Investigational Site Number 2760005', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '83471', 'city': 'Schönau', 'country': 'Germany', 'facility': 'Investigational Site Number 2760006', 'geoPoint': {'lat': 49.43665, 'lon': 8.8088}}, {'zip': '74193', 'city': 'Schwaigern', 'country': 'Germany', 'facility': 'Investigational Site Number 2760008', 'geoPoint': {'lat': 49.14494, 'lon': 9.05525}}, {'zip': '76889', 'city': 'Schweigen', 'country': 'Germany', 'facility': 'Investigational Site Number 2760009', 'geoPoint': {'lat': 49.05055, 'lon': 7.95354}}, {'zip': '97941', 'city': 'Tauberbischofsheim', 'country': 'Germany', 'facility': 'Investigational Site Number 2760018', 'geoPoint': {'lat': 49.62472, 'lon': 9.66278}}, {'zip': '78532', 'city': 'Tuttlingen', 'country': 'Germany', 'facility': 'Investigational Site Number 2760010', 'geoPoint': {'lat': 47.98464, 'lon': 8.8177}}, {'zip': '38448', 'city': 'Wolfsburg', 'country': 'Germany', 'facility': 'Investigational Site Number 2760012', 'geoPoint': {'lat': 52.42452, 'lon': 10.7815}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur, a Sanofi Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}