Viewing Study NCT00850603

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Ignite Creation Date: 2025-12-24 @ 7:39 PM
Ignite Modification Date: 2025-12-31 @ 6:37 AM
Study NCT ID: NCT00850603
Status: COMPLETED
Last Update Posted: 2016-04-14
First Post: 2009-02-24
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject 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': 'Adverse events data were collected from the day of vaccination for 28 days post-vaccination', 'eventGroups': [{'id': 'EG000', 'title': '0.5 mL Subcutaneous Menomune®', 'description': 'Participants received 0.5 mL Subcutaneous Menomune®', 'otherNumAtRisk': 34, 'otherNumAffected': 8, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.1 mL Subcutaneous Menomune®', 'description': 'Participants received 0.1 mL Subcutaneous Menomune®', 'otherNumAtRisk': 34, 'otherNumAffected': 9, 'seriousNumAtRisk': 34, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '0.05 mL Intradermal Menomune®', 'description': 'Participants received 0.05 mL Intradermal Menomune®', 'otherNumAtRisk': 34, 'otherNumAffected': 9, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '0.1 mL Intradermal Menomune®', 'description': 'Participants received 0.1 mL Intradermal Menomune®', 'otherNumAtRisk': 34, 'otherNumAffected': 10, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '0.15 mL Intradermal Menomune®', 'description': 'Participants received 0.15 mL Intradermal Menomune®', 'otherNumAtRisk': 34, 'otherNumAffected': 18, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'seriousEvents': [{'term': 'Abdominal pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mL Subcutaneous Menomune®', 'description': 'Participants received 0.5 mL Subcutaneous Menomune®'}, {'id': 'OG001', 'title': '0.1 mL Subcutaneous Menomune®', 'description': 'Participants received 0.1 mL Subcutaneous Menomune®'}, {'id': 'OG002', 'title': '0.05 mL Intradermal Menomune®', 'description': 'Participants received 0.05 mL Intradermal Menomune®'}, {'id': 'OG003', 'title': '0.1 mL Intradermal Menomune®', 'description': 'Participants received 0.1 mL Intradermal Menomune®'}, {'id': 'OG004', 'title': '0.15 mL Intradermal Menomune®', 'description': 'Participants received 0.15 mL Intradermal Menomune®'}], 'classes': [{'title': 'Meningococcal serogroup A', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}]}]}, {'title': 'Meningococcal serogroup C', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}]}]}, {'title': 'Meningococcal serogroup Y', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}]}, {'title': 'Meningococcal serogroup W-135', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 28 days post vaccination', 'description': 'Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '4-Fold rise analysis was in the per-protocol population with valid serology data'}, {'type': 'SECONDARY', 'title': 'Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mL Subcutaneous Menomune®', 'description': 'Participants received 0.5 mL Subcutaneous Menomune®'}, {'id': 'OG001', 'title': '0.1 mL Subcutaneous Menomune®', 'description': 'Participants received 0.1 mL Subcutaneous Menomune®'}, {'id': 'OG002', 'title': '0.05 mL Intradermal Menomune®', 'description': 'Participants received 0.05 mL Intradermal Menomune®'}, {'id': 'OG003', 'title': '0.1 mL Intradermal Menomune®', 'description': 'Participants received 0.1 mL Intradermal Menomune®'}, {'id': 'OG004', 'title': '0.15 mL Intradermal Menomune®', 'description': 'Participants received 0.15 mL Intradermal Menomune®'}], 'classes': [{'title': 'Any Local Reaction', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Any Grade 3 Local Reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness ( ≥ 2 inchs)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling ( ≥ 2 inchs)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Tenderness (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Systemic Reaction', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any Grade 3 Systemic Reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Fever (≥ 39.6 ºC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Chills', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Chills (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Headache (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Dizziness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Dizziness (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Malaise (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Myalgia (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Nausea (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Vomiting (≥3 episodes)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Diarrhea (≥3 episodes)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Arthralgia (disabling)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Injection site Rash', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to 7 days post-vaccination', 'description': 'Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mL Subcutaneous Menomune®', 'description': 'Participants received 0.5 mL Subcutaneous Menomune®'}, {'id': 'OG001', 'title': '0.1 mL Subcutaneous Menomune®', 'description': 'Participants received 0.1 mL Subcutaneous Menomune®'}, {'id': 'OG002', 'title': '0.05 mL Intradermal Menomune®', 'description': 'Participants received 0.05 mL Intradermal Menomune®'}, {'id': 'OG003', 'title': '0.1 mL Intradermal Menomune®', 'description': 'Participants received 0.1 mL Intradermal Menomune®'}, {'id': 'OG004', 'title': '0.15 mL Intradermal Menomune®', 'description': 'Participants received 0.15 mL Intradermal Menomune®'}], 'classes': [{'title': 'Meningococcal serogroup A (Day 0)', 'categories': [{'measurements': [{'value': '462.4', 'groupId': 'OG000', 'lowerLimit': '222.4', 'upperLimit': '961.4'}, {'value': '320.4', 'groupId': 'OG001', 'lowerLimit': '127.7', 'upperLimit': '803.8'}, {'value': '267.0', 'groupId': 'OG002', 'lowerLimit': '114.5', 'upperLimit': '622.7'}, {'value': '381.6', 'groupId': 'OG003', 'lowerLimit': '195.7', 'upperLimit': '743.8'}, {'value': '261.6', 'groupId': 'OG004', 'lowerLimit': '131.1', 'upperLimit': '522.1'}]}]}, {'title': 'Meningococcal serogroup A (Day 28)', 'categories': [{'measurements': [{'value': '5496.3', 'groupId': 'OG000', 'lowerLimit': '3262.8', 'upperLimit': '9258.7'}, {'value': '3662.7', 'groupId': 'OG001', 'lowerLimit': '2392.4', 'upperLimit': '5607.7'}, {'value': '1775.6', 'groupId': 'OG002', 'lowerLimit': '1116.3', 'upperLimit': '2824.5'}, {'value': '3079.0', 'groupId': 'OG003', 'lowerLimit': '2298.4', 'upperLimit': '4124.7'}, {'value': '4013.3', 'groupId': 'OG004', 'lowerLimit': '2575.7', 'upperLimit': '6253.4'}]}]}, {'title': 'Meningococcal serogroup C (Day 0)', 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '115.0'}, {'value': '85.1', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '209.7'}, {'value': '50.8', 'groupId': 'OG002', 'lowerLimit': '20.7', 'upperLimit': '124.4'}, {'value': '53.0', 'groupId': 'OG003', 'lowerLimit': '21.6', 'upperLimit': '129.7'}, {'value': '41.5', 'groupId': 'OG004', 'lowerLimit': '18.8', 'upperLimit': '91.4'}]}]}, {'title': 'Meningococcal serogroup C (Day 28)', 'categories': [{'measurements': [{'value': '2989.0', 'groupId': 'OG000', 'lowerLimit': '1475.1', 'upperLimit': '6056.5'}, {'value': '1751.3', 'groupId': 'OG001', 'lowerLimit': '934.0', 'upperLimit': '3283.8'}, {'value': '1478.0', 'groupId': 'OG002', 'lowerLimit': '647.4', 'upperLimit': '3374.3'}, {'value': '1307.8', 'groupId': 'OG003', 'lowerLimit': '661.8', 'upperLimit': '2584.4'}, {'value': '2780.6', 'groupId': 'OG004', 'lowerLimit': '1428.3', 'upperLimit': '5413.2'}]}]}, {'title': 'Meningococcal serogroup Y (Day 0)', 'categories': [{'measurements': [{'value': '301.3', 'groupId': 'OG000', 'lowerLimit': '138.3', 'upperLimit': '656.5'}, {'value': '166.8', 'groupId': 'OG001', 'lowerLimit': '73.0', 'upperLimit': '381.5'}, {'value': '164.7', 'groupId': 'OG002', 'lowerLimit': '73.3', 'upperLimit': '370.2'}, {'value': '216.4', 'groupId': 'OG003', 'lowerLimit': '103.8', 'upperLimit': '451.2'}, {'value': '189.0', 'groupId': 'OG004', 'lowerLimit': '93.5', 'upperLimit': '382.1'}]}]}, {'title': 'Meningococcal serogroup Y (Day 28)', 'categories': [{'measurements': [{'value': '1883.0', 'groupId': 'OG000', 'lowerLimit': '1185.2', 'upperLimit': '2991.4'}, {'value': '2002.7', 'groupId': 'OG001', 'lowerLimit': '1163.3', 'upperLimit': '3447.9'}, {'value': '1390.3', 'groupId': 'OG002', 'lowerLimit': '742.1', 'upperLimit': '2604.8'}, {'value': '1603.6', 'groupId': 'OG003', 'lowerLimit': '1111.6', 'upperLimit': '2313.3'}, {'value': '1887.6', 'groupId': 'OG004', 'lowerLimit': '1120.4', 'upperLimit': '3180.3'}]}]}, {'title': 'Meningococcal serogroup W-135 (Day 0)', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '69.8'}, {'value': '37.7', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '74.7'}, {'value': '47.7', 'groupId': 'OG002', 'lowerLimit': '24.5', 'upperLimit': '93.0'}, {'value': '34.1', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '72.8'}, {'value': '19.4', 'groupId': 'OG004', 'lowerLimit': '9.7', 'upperLimit': '38.9'}]}]}, {'title': 'Meningococcal serogroup W-135 (Day 28)', 'categories': [{'measurements': [{'value': '1374.1', 'groupId': 'OG000', 'lowerLimit': '846.9', 'upperLimit': '2229.4'}, {'value': '856.3', 'groupId': 'OG001', 'lowerLimit': '465.9', 'upperLimit': '1573.8'}, {'value': '1390.3', 'groupId': 'OG002', 'lowerLimit': '805.1', 'upperLimit': '2400.9'}, {'value': '1307.8', 'groupId': 'OG003', 'lowerLimit': '881.6', 'upperLimit': '1940.2'}, {'value': '2006.7', 'groupId': 'OG004', 'lowerLimit': '1204.5', 'upperLimit': '3343.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 0) and Day 28 post-vaccination', 'description': 'GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were determined in the per-protocol population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.5 mL Subcutaneous Menomune®', 'description': 'Participants received 0.5 mL Subcutaneous Menomune®'}, {'id': 'FG001', 'title': '0.1 mL Subcutaneous Menomune®', 'description': 'Participants received 0.1 mL Subcutaneous Menomune®'}, {'id': 'FG002', 'title': '0.05 mL Intradermal Menomune®', 'description': 'Participants received 0.05 mL Intradermal Menomune®'}, {'id': 'FG003', 'title': '0.1 mL Intradermal Menomune®', 'description': 'Participants received 0.1 mL Intradermal Menomune®'}, {'id': 'FG004', 'title': '0.15 mL Intradermal Menomune®', 'description': 'Participants received 0.15 mL Intradermal Menomune®'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from 15 through 16 October 2002 in 1 US site', 'preAssignmentDetails': 'A total of 170 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '170', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '0.5 mL Subcutaneous Menomune®', 'description': 'Participants received 0.5 mL Subcutaneous Menomune®'}, {'id': 'BG001', 'title': '0.1 mL Subcutaneous Menomune®', 'description': 'Participants received 0.1 mL Subcutaneous Menomune®'}, {'id': 'BG002', 'title': '0.05 mL Intradermal Menomune®', 'description': 'Participants received 0.05 mL Intradermal Menomune®'}, {'id': 'BG003', 'title': '0.1 mL Intradermal Menomune®', 'description': 'Participants received 0.1 mL Intradermal Menomune®'}, {'id': 'BG004', 'title': '0.15 mL Intradermal Menomune®', 'description': 'Participants received 0.15 mL Intradermal Menomune®'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '159', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '9.68', 'groupId': 'BG000'}, {'value': '24.3', 'spread': '7.10', 'groupId': 'BG001'}, {'value': '24.4', 'spread': '7.64', 'groupId': 'BG002'}, {'value': '24.5', 'spread': '8.46', 'groupId': 'BG003'}, {'value': '28.9', 'spread': '12.85', 'groupId': 'BG004'}, {'value': '25.6', 'spread': '9.42', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '170', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2009-02-24', 'resultsFirstSubmitDate': '2009-03-13', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-13', 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers', 'timeFrame': 'Baseline to 28 days post vaccination', 'description': 'Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.'}, {'measure': 'Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.', 'timeFrame': 'Baseline (Day 0) and Day 28 post-vaccination', 'description': 'GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.'}], 'secondaryOutcomes': [{'measure': 'Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.', 'timeFrame': 'Day 0 to 7 days post-vaccination', 'description': 'Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Menomune® - A/C/Y/W-135', 'Meningococcal Infections', 'Meningitis'], 'conditions': ['Meningococcal Infections', 'Meningitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously.\n\nThe secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages', 'detailedDescription': 'This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to a low dose given SC.\n\nSubjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* 18 to 55 years of age.\n* Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.\n* Signed an informed consent form.\n\nExclusion Criteria :\n\n* Allergy to any component of the vaccine and latex.\n* Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months.\n* History of serious chronic diseases (such as cardiac or renal disease).\n* Acute febrile illness at the time of visit.\n* Pregnancy.\n* Receipt of any vaccine within the 28 days prior to enrollment.\n* Receipt of meningococcal vaccine (example in Military) within the past 5 years or history of meningococcal disease.'}, 'identificationModule': {'nctId': 'NCT00850603', 'briefTitle': 'Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135', 'orgStudyIdInfo': {'id': 'MPT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': '0.5 mL Subcutaneous arm (Menomune® )', 'interventionNames': ['Biological: Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '0.1 mL Subcutaneous arm (Menomune®)', 'interventionNames': ['Biological: Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': '0.05 mL Intradermal arm (Menomune®)', 'interventionNames': ['Biological: Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': '0.1 mL Intradermal arm (Menomune®)', 'interventionNames': ['Biological: Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5', 'description': '0.15 mL Intradermal arm (Menomune®)', 'interventionNames': ['Biological: Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined']}], 'interventions': [{'name': 'Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined', 'type': 'BIOLOGICAL', 'otherNames': ['Menomune® - A/C/Y/W-135'], 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['Group 1']}, {'name': 'Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined', 'type': 'BIOLOGICAL', 'otherNames': ['Menomune® - A/C/Y/W-135'], 'description': '0.1 mL, Subcutaneous', 'armGroupLabels': ['Group 2']}, {'name': 'Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined', 'type': 'BIOLOGICAL', 'otherNames': ['Menomune® - A/C/Y/W-135'], 'description': '0.05 mL, Intradermal', 'armGroupLabels': ['Group 3']}, {'name': 'Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined', 'type': 'BIOLOGICAL', 'otherNames': ['Menomune® - A/C/Y/W-135'], 'description': '0.1 mL, Intradermal', 'armGroupLabels': ['Group 4']}, {'name': 'Meningococcal Polysaccharide Groups A\\C\\Y\\W-135 Combined', 'type': 'BIOLOGICAL', 'otherNames': ['Menomune® - A/C/Y/W-135'], 'description': '0.15 mL, Intradermal', 'armGroupLabels': ['Group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18301', 'city': 'East Stroudsburg', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.99954, 'lon': -75.18129}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}