Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-03 @ 6:11 AM
Study NCT ID:
NCT01513551
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2011-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)
Sponsor:
Organization:
Raw JSON
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Any information identified by the SPONSOR as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months postvaccination', 'description': 'The at-risk population consisted of all participants who received study vaccination and had safety follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'V114', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.', 'otherNumAtRisk': 229, 'deathsNumAtRisk': 229, 'otherNumAffected': 167, 'seriousNumAtRisk': 229, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'PNEUMOVAX® 23', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 149, 'seriousNumAtRisk': 230, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'PREVNAR 13®', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 141, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 68, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 89, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 75, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 145, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 126, 'numAffected': 118}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 137, 'numAffected': 122}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 48, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 45, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 41, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 74, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 72, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 60, 'numAffected': 50}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 43, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 55, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 53, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign urinary tract neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX® 23', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.'}, {'id': 'OG002', 'title': 'PREVNAR 13®', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.1', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}, {'value': '65.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '15.0', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '1.1', 'ciUpperLimit': '17.7', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination', 'description': "An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of those participants who received study vaccination and had safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX® 23', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.'}, {'id': 'OG002', 'title': 'PREVNAR 13®', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '14.8', 'groupId': 'OG001'}, {'value': '13.0', 'groupId': 'OG002'}]}]}, {'title': 'Injection site induration', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}, {'value': '12.6', 'groupId': 'OG002'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000'}, {'value': '51.3', 'groupId': 'OG001'}, {'value': '53.0', 'groupId': 'OG002'}]}]}, {'title': 'Injection site pruritus', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}]}]}, {'title': 'Injection site warmth', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 14 postvaccination', 'description': 'Injection-site AEs reported by \\>=2% of participants in one or more vaccination groups were assessed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of those participants who received study vaccination and had safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX® 23', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.'}, {'id': 'OG002', 'title': 'PREVNAR 13®', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '43.9', 'groupId': 'OG001'}, {'value': '45.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 14 postvaccination', 'description': 'Systemic AEs reported by \\>=2% of participants in one or more vaccination groups were assessed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of those participants who received study vaccination and had safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX® 23', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.'}, {'id': 'OG002', 'title': 'PREVNAR 13®', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months postvaccination', 'description': 'A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of those participants who received study vaccination and had safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Vaccine-related Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX® 23', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.'}, {'id': 'OG002', 'title': 'PREVNAR 13®', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months postvaccination', 'description': 'A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of those participants who received study vaccination and had safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX® 23', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.'}, {'id': 'OG002', 'title': 'PREVNAR 13®', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.76', 'groupId': 'OG000', 'lowerLimit': '3.05', 'upperLimit': '4.65'}, {'value': '3.30', 'groupId': 'OG001', 'lowerLimit': '2.68', 'upperLimit': '4.07'}, {'value': '3.12', 'groupId': 'OG002', 'lowerLimit': '2.54', 'upperLimit': '3.82'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.35'}, {'value': '0.57', 'groupId': 'OG001', 'lowerLimit': '0.47', 'upperLimit': '0.68'}, 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{'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}, {'value': '641', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline analysis population consisted of all randomized participants who received study vaccine.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 692}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2013-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-26', 'studyFirstSubmitDate': '2011-12-27', 'resultsFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2012-01-16', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-26', 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With an Adverse Event', 'timeFrame': 'All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination', 'description': "An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience."}, {'measure': 'Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups', 'timeFrame': 'Up to Day 14 postvaccination', 'description': 'Injection-site AEs reported by \\>=2% of participants in one or more vaccination groups were assessed.'}, {'measure': 'Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups', 'timeFrame': 'Up to Day 14 postvaccination', 'description': 'Systemic AEs reported by \\>=2% of participants in one or more vaccination groups were assessed.'}, {'measure': 'Percentage of Participants With a Serious Adverse Event', 'timeFrame': 'Up to 6 months postvaccination', 'description': 'A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.'}, {'measure': 'Percentage of Participants With a Vaccine-related Serious Adverse Event', 'timeFrame': 'Up to 6 months postvaccination', 'description': 'A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.'}, {'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies', 'timeFrame': 'One month postvaccination', 'description': 'Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies', 'timeFrame': 'One month postvaccination', 'description': 'OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pneumococcal vaccines'], 'conditions': ['Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '29559167', 'type': 'DERIVED', 'citation': 'Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=50 years of age. Vaccine. 2018 Oct 29;36(45):6875-6882. doi: 10.1016/j.vaccine.2018.03.012. Epub 2018 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older.\n\nThe primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Without fever for 72 hours prior to vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine\n* Known or suspected to be immunocompromised\n* Functional or anatomic asplenia\n* History of autoimmune disease\n* Evidence of dementia or cognitive impairment\n* Use of any immunosuppressive therapy\n* Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine\n* Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine\n* Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine\n* Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine\n* History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease\n* Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine'}, 'identificationModule': {'nctId': 'NCT01513551', 'briefTitle': 'The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and PREVNAR 13® (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older', 'orgStudyIdInfo': {'id': 'V114-002'}, 'secondaryIdInfos': [{'id': '2011-004542-18', 'type': 'OTHER', 'domain': 'EudraCT Number'}, {'id': 'V114-002', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V114', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.', 'interventionNames': ['Biological: Pneumococcal Conjugate Vaccine (V114)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PNEUMOVAX® 23', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.', 'interventionNames': ['Biological: PNEUMOVAX® 23']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PREVNAR 13®', 'description': 'Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.', 'interventionNames': ['Biological: PREVNAR 13®']}], 'interventions': [{'name': 'Pneumococcal Conjugate Vaccine (V114)', 'type': 'BIOLOGICAL', 'description': '15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.', 'armGroupLabels': ['V114']}, {'name': 'PNEUMOVAX® 23', 'type': 'BIOLOGICAL', 'description': '23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.', 'armGroupLabels': ['PNEUMOVAX® 23']}, {'name': 'PREVNAR 13®', 'type': 'BIOLOGICAL', 'description': '13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.', 'armGroupLabels': ['PREVNAR 13®']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}