Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-29 @ 3:28 AM
Study NCT ID:
NCT00822757
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)', 'eventGroups': [{'id': 'EG000', 'title': 'V710 (60 mcg) Lyophilized', 'description': 'V710 (60 mcg)single dose at baseline.', 'otherNumAtRisk': 41, 'otherNumAffected': 15, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Saline placebo single dose at baseline.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V710 (60 mcg) Lyophilized', 'description': 'V710 (60 mcg) single dose at baseline.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Saline placebo single dose at baseline.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '7.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prevaccination to 14 days postvaccination', 'description': 'Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'GMFR by Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V710 (60 mcg) Lyophilized', 'description': 'V710 (60 mcg) single dose at baseline.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Saline placebo single dose at baseline.'}], 'classes': [{'title': 'Age <60 years', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '6.2'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.0'}]}]}, {'title': 'Age ≥60 years', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '10.8'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prevaccination to 14 days postvaccination', 'description': 'Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'GMFR in Antibody Concentration From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V710 (60 mcg) Lyophilized', 'description': 'V710 (60 mcg) single dose at baseline.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Saline placebo single dose at baseline.'}], 'classes': [{'title': 'Day 10', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '5.0'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '2.2'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '7.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.0'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '9.9'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.0'}]}]}, {'title': 'Day 84', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '11.2'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prevaccination to Days 10, 14, 28, and 84 postvaccination', 'description': 'An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V710 (60 mcg) Lyophilized', 'description': 'V710 (60 mcg) single dose at baseline.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Saline placebo single dose at baseline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'V710 (60 mcg) Lyophilized', 'description': 'V710 (60 mcg) single dose at baseline.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Saline placebo single dose at baseline.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '17 years of age and under', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18 to 29 years of age', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '30 to 39 years of age', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '40 to 49 years of age', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '50 to 59 years of age', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '60 to 69 years of age', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '70 to 80 years of age', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2009-01-13', 'resultsFirstSubmitDate': '2011-06-22', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-13', 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'GMFR by Age', 'timeFrame': 'Prevaccination to 14 days postvaccination', 'description': 'Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac.'}, {'measure': 'GMFR in Antibody Concentration From Baseline', 'timeFrame': 'Prevaccination to Days 10, 14, 28, and 84 postvaccination', 'description': 'An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.'}], 'primaryOutcomes': [{'measure': 'Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).', 'timeFrame': 'Prevaccination to 14 days postvaccination', 'description': 'Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['study in healthy subjects'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '22192849', 'type': 'RESULT', 'citation': 'Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA. The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies. Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 80 years of age\n* Good physical health based upon medical history and physical examination\n* Willing and able to participate in the entire study duration\n* Female subject with a negative urine pregnancy test immediately prior to study vaccination\n\nExclusion Criteria:\n\n* Chronic skin infections or a chronic skin condition (e.g. psoriasis)\n* Serious S. aureus infection in the last 12 months\n* Allergy to aluminum-containing substance taken in the body or to any other vaccine component\n* Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days\n* Participation in a prior V710 vaccine clinical study\n* Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration'}, 'identificationModule': {'nctId': 'NCT00822757', 'briefTitle': 'Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults', 'orgStudyIdInfo': {'id': 'V710-004'}, 'secondaryIdInfos': [{'id': '2007_531'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'V710', 'interventionNames': ['Biological: Comparator: V710']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Biological: Comparator: placebo']}], 'interventions': [{'name': 'Comparator: V710', 'type': 'BIOLOGICAL', 'description': 'Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.', 'armGroupLabels': ['1']}, {'name': 'Comparator: placebo', 'type': 'BIOLOGICAL', 'description': 'Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}