Viewing Study NCT03480802

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Ignite Creation Date: 2025-12-25 @ 3:52 AM
Ignite Modification Date: 2026-03-09 @ 8:18 AM
Study NCT ID: NCT03480802
Status: COMPLETED
Last Update Posted: 2022-05-05
First Post: 2018-03-22
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)
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': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}]}}, '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': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.', 'description': 'The population reported was all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23 (PPV23).', 'eventGroups': [{'id': 'EG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1).', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 103, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1).', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 88, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'V114 (Post-PPV23)', 'description': 'Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 (PPV23) at Week 8 (Vaccination 2).', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 88, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Prevnar 13™ (Post-PPV23)', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PPV23 at Week 8 (Vaccination 2).', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 99, 'seriousNumAtRisk': 148, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 34, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 100, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 86, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 97, 'numAffected': 80}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 101, 'numAffected': 92}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '9.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '7.6'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '65.2'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '43.0', 'upperLimit': '59.6'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '18.1'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '8.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after Vaccination 1 (Up to Day 5)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of the study vaccination they actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '7.5'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '8.5'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '27.7'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '19.8'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '19.6'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '15.2'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '18.8'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '15.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after Vaccination 1 (Up to Day 14)', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of the study vaccination they actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 8 weeks after Vaccination 1 (Up to Week 8)', 'description': 'A serious adverse event (SAE) is an AE that 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. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of the study vaccination they actually received.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '238.8', 'groupId': 'OG000', 'lowerLimit': '173.1', 'upperLimit': '329.3'}, {'value': '200.9', 'groupId': 'OG001', 'lowerLimit': '142.7', 'upperLimit': '282.7'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.8', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '143.7'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '58.6', 'upperLimit': '89.2'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '824.0', 'groupId': 'OG000', 'lowerLimit': '618.8', 'upperLimit': '1097.2'}, {'value': '1465.5', 'groupId': 'OG001', 'lowerLimit': '1154.5', 'upperLimit': '1860.3'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '336.7', 'groupId': 'OG000', 'lowerLimit': '242.4', 'upperLimit': '467.7'}, {'value': '276.7', 'groupId': 'OG001', 'lowerLimit': '197.9', 'upperLimit': '386.7'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6421.0', 'groupId': 'OG000', 'lowerLimit': '4890.4', 'upperLimit': '8430.7'}, {'value': '5645.1', 'groupId': 'OG001', 'lowerLimit': '4278.9', 'upperLimit': '7447.4'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4772.9', 'groupId': 'OG000', 'lowerLimit': '3628.3', 'upperLimit': '6278.7'}, {'value': '3554.0', 'groupId': 'OG001', 'lowerLimit': '2751.0', 'upperLimit': '4591.4'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6085.8', 'groupId': 'OG000', 'lowerLimit': '4871.6', 'upperLimit': '7602.8'}, {'value': '6144.3', 'groupId': 'OG001', 'lowerLimit': '4982.8', 'upperLimit': '7576.6'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2836.3', 'groupId': 'OG000', 'lowerLimit': '2311.5', 'upperLimit': '3480.4'}, {'value': '2133.9', 'groupId': 'OG001', 'lowerLimit': '1721.8', 'upperLimit': '2644.5'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3508.7', 'groupId': 'OG000', 'lowerLimit': '2730.6', 'upperLimit': '4508.5'}, {'value': '3000.3', 'groupId': 'OG001', 'lowerLimit': '2350.0', 'upperLimit': '3830.5'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3002.2', 'groupId': 'OG000', 'lowerLimit': '2435.5', 'upperLimit': '3700.8'}, {'value': '1560.3', 'groupId': 'OG001', 'lowerLimit': '1213.8', 'upperLimit': '2005.6'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4240.7', 'groupId': 'OG000', 'lowerLimit': '3415.4', 'upperLimit': '5265.3'}, {'value': '3715.9', 'groupId': 'OG001', 'lowerLimit': '2949.2', 'upperLimit': '4681.8'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2438.6', 'groupId': 'OG000', 'lowerLimit': '1972.7', 'upperLimit': '3014.6'}, {'value': '2042.0', 'groupId': 'OG001', 'lowerLimit': '1618.9', 'upperLimit': '2575.5'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1757.4', 'groupId': 'OG000', 'lowerLimit': '1276.1', 'upperLimit': '2420.2'}, {'value': '1787.0', 'groupId': 'OG001', 'lowerLimit': '1309.0', 'upperLimit': '2437.9'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3943.7', 'groupId': 'OG000', 'lowerLimit': '3049.2', 'upperLimit': '5100.5'}, {'value': '109.3', 'groupId': 'OG001', 'lowerLimit': '66.2', 'upperLimit': '180.3'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11342.4', 'groupId': 'OG000', 'lowerLimit': '9184.3', 'upperLimit': '14007.6'}, {'value': '1807.6', 'groupId': 'OG001', 'lowerLimit': '1357.3', 'upperLimit': '2407.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). This assay reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.', 'unitOfMeasure': '1/dil', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include blood draw out of window, prohibited concomitant medication or vaccine, violations of key inclusion/exclusion criteria, or missing serology results.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.16', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '4.01'}, {'value': '4.27', 'groupId': 'OG001', 'lowerLimit': '3.31', 'upperLimit': '5.50'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '0.68'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.60'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.44'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.56', 'upperLimit': '2.55'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.38', 'groupId': 'OG000', 'lowerLimit': '1.89', 'upperLimit': '3.01'}, {'value': '2.03', 'groupId': 'OG001', 'lowerLimit': '1.56', 'upperLimit': '2.64'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.13', 'groupId': 'OG000', 'lowerLimit': '3.73', 'upperLimit': '7.04'}, {'value': '4.91', 'groupId': 'OG001', 'lowerLimit': '3.49', 'upperLimit': '6.91'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.17', 'groupId': 'OG000', 'lowerLimit': '5.34', 'upperLimit': '9.63'}, {'value': '5.23', 'groupId': 'OG001', 'lowerLimit': '3.73', 'upperLimit': '7.35'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '3.41'}, {'value': '3.74', 'groupId': 'OG001', 'lowerLimit': '2.91', 'upperLimit': '4.81'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.35', 'groupId': 'OG000', 'lowerLimit': '2.71', 'upperLimit': '4.14'}, {'value': '3.55', 'groupId': 'OG001', 'lowerLimit': '2.77', 'upperLimit': '4.56'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.44', 'groupId': 'OG000', 'lowerLimit': '11.69', 'upperLimit': '20.39'}, {'value': '15.22', 'groupId': 'OG001', 'lowerLimit': '11.56', 'upperLimit': '20.03'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.58', 'groupId': 'OG000', 'lowerLimit': '4.33', 'upperLimit': '7.18'}, {'value': '5.07', 'groupId': 'OG001', 'lowerLimit': '3.97', 'upperLimit': '6.48'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.09', 'groupId': 'OG000', 'lowerLimit': '7.08', 'upperLimit': '11.67'}, {'value': '9.61', 'groupId': 'OG001', 'lowerLimit': '7.36', 'upperLimit': '12.56'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.41', 'groupId': 'OG000', 'lowerLimit': '4.89', 'upperLimit': '8.39'}, {'value': '6.21', 'groupId': 'OG001', 'lowerLimit': '4.73', 'upperLimit': '8.15'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.92', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '5.22'}, {'value': '4.90', 'groupId': 'OG001', 'lowerLimit': '3.54', 'upperLimit': '6.77'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.97', 'groupId': 'OG000', 'lowerLimit': '3.06', 'upperLimit': '5.15'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.25'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.83', 'groupId': 'OG000', 'lowerLimit': '5.14', 'upperLimit': '9.07'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.62', 'upperLimit': '0.95'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': "The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.", 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include blood draw out of window, prohibited concomitant medication or vaccine, violations of key inclusion/exclusion criteria, or missing serology results'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '16.0'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '18.5'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '61.5'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '53.1', 'upperLimit': '69.4'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '27.3'}, {'value': '29.1', 'groupId': 'OG001', 'lowerLimit': '21.9', 'upperLimit': '37.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after Vaccination 2 (Up to Day 61)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of the study vaccination they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '6.7'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.8'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '19.1'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '17.0'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '14.4'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '14.6'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '17.5'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '18.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after Vaccination 2 (Up to Day 70)', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of the study vaccination they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 8 up to Month 6', 'description': 'A serious adverse event (SAE) is an AE that 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. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of the study vaccination they actually received.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer of Serotype-specific OPA After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '212.0', 'groupId': 'OG000', 'lowerLimit': '160.5', 'upperLimit': '280.2'}, {'value': '154.0', 'groupId': 'OG001', 'lowerLimit': '111.6', 'upperLimit': '212.4'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102.8', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '127.2'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '117.4'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '915.4', 'groupId': 'OG000', 'lowerLimit': '722.9', 'upperLimit': '1159.1'}, {'value': '984.7', 'groupId': 'OG001', 'lowerLimit': '772.1', 'upperLimit': '1255.7'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '418.1', 'groupId': 'OG000', 'lowerLimit': '312.1', 'upperLimit': '560.3'}, {'value': '274.5', 'groupId': 'OG001', 'lowerLimit': '199.9', 'upperLimit': '376.8'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4065.4', 'groupId': 'OG000', 'lowerLimit': '3052.1', 'upperLimit': '5415.1'}, {'value': '4593.2', 'groupId': 'OG001', 'lowerLimit': '3543.0', 'upperLimit': '5954.7'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3661.1', 'groupId': 'OG000', 'lowerLimit': '2735.1', 'upperLimit': '4900.6'}, {'value': '2826.4', 'groupId': 'OG001', 'lowerLimit': '2202.7', 'upperLimit': '3626.8'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5983.5', 'groupId': 'OG000', 'lowerLimit': '4788.9', 'upperLimit': '7476.1'}, {'value': '5516.5', 'groupId': 'OG001', 'lowerLimit': '4522.2', 'upperLimit': '6729.5'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2454.8', 'groupId': 'OG000', 'lowerLimit': '2008.7', 'upperLimit': '3000.0'}, {'value': '1929.9', 'groupId': 'OG001', 'lowerLimit': '1567.7', 'upperLimit': '2375.7'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3634.0', 'groupId': 'OG000', 'lowerLimit': '2935.6', 'upperLimit': '4498.5'}, {'value': '2539.3', 'groupId': 'OG001', 'lowerLimit': '1960.6', 'upperLimit': '3288.9'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2511.5', 'groupId': 'OG000', 'lowerLimit': '1958.7', 'upperLimit': '3220.3'}, {'value': '1753.8', 'groupId': 'OG001', 'lowerLimit': '1428.6', 'upperLimit': '2153.1'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3358.1', 'groupId': 'OG000', 'lowerLimit': '2679.6', 'upperLimit': '4208.4'}, {'value': '3300.3', 'groupId': 'OG001', 'lowerLimit': '2638.7', 'upperLimit': '4127.7'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2230.7', 'groupId': 'OG000', 'lowerLimit': '1803.6', 'upperLimit': '2759.0'}, {'value': '1994.1', 'groupId': 'OG001', 'lowerLimit': '1630.7', 'upperLimit': '2438.4'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1641.2', 'groupId': 'OG000', 'lowerLimit': '1217.2', 'upperLimit': '2212.9'}, {'value': '1266.5', 'groupId': 'OG001', 'lowerLimit': '944.3', 'upperLimit': '1698.5'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3399.9', 'groupId': 'OG000', 'lowerLimit': '2697.6', 'upperLimit': '4285.0'}, {'value': '2952.7', 'groupId': 'OG001', 'lowerLimit': '2207.7', 'upperLimit': '3949.1'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10576.3', 'groupId': 'OG000', 'lowerLimit': '8383.1', 'upperLimit': '13343.4'}, {'value': '11926.3', 'groupId': 'OG001', 'lowerLimit': '9085.9', 'upperLimit': '15654.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 12', 'description': 'Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA. The MOPA reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.', 'unitOfMeasure': '1/dil', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include not vaccinated at week 8, vaccination out of window, blood draw out of window, prohibited concomitant medication or vaccine, violations of key inclusion/exclusion criteria, or missing serology results.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.80', 'groupId': 'OG000', 'lowerLimit': '2.25', 'upperLimit': '3.49'}, {'value': '4.04', 'groupId': 'OG001', 'lowerLimit': '3.27', 'upperLimit': '5.00'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.61'}, {'value': '0.59', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.70'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '1.57'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': '1.98'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '2.08', 'upperLimit': '3.28'}, {'value': '2.13', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '2.68'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.12', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '4.30'}, {'value': '3.71', 'groupId': 'OG001', 'lowerLimit': '2.74', 'upperLimit': '5.03'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.69', 'groupId': 'OG000', 'lowerLimit': '3.52', 'upperLimit': '6.25'}, {'value': '4.35', 'groupId': 'OG001', 'lowerLimit': '3.23', 'upperLimit': '5.86'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': '3.15'}, {'value': '3.17', 'groupId': 'OG001', 'lowerLimit': '2.60', 'upperLimit': '3.87'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.92', 'groupId': 'OG000', 'lowerLimit': '2.39', 'upperLimit': '3.57'}, {'value': '3.24', 'groupId': 'OG001', 'lowerLimit': '2.62', 'upperLimit': '4.01'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.68', 'groupId': 'OG000', 'lowerLimit': '10.34', 'upperLimit': '18.10'}, {'value': '14.37', 'groupId': 'OG001', 'lowerLimit': '11.25', 'upperLimit': '18.36'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.96', 'groupId': 'OG000', 'lowerLimit': '3.08', 'upperLimit': '5.09'}, {'value': '3.96', 'groupId': 'OG001', 'lowerLimit': '3.18', 'upperLimit': '4.95'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.23', 'groupId': 'OG000', 'lowerLimit': '5.80', 'upperLimit': '9.02'}, {'value': '8.54', 'groupId': 'OG001', 'lowerLimit': '6.80', 'upperLimit': '10.72'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.19', 'groupId': 'OG000', 'lowerLimit': '4.06', 'upperLimit': '6.62'}, {'value': '5.84', 'groupId': 'OG001', 'lowerLimit': '4.67', 'upperLimit': '7.30'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.21', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '4.25'}, {'value': '3.74', 'groupId': 'OG001', 'lowerLimit': '2.85', 'upperLimit': '4.91'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.94', 'groupId': 'OG000', 'lowerLimit': '3.07', 'upperLimit': '5.05'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '2.75', 'upperLimit': '4.45'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.18', 'groupId': 'OG000', 'lowerLimit': '4.72', 'upperLimit': '8.09'}, {'value': '9.20', 'groupId': 'OG001', 'lowerLimit': '7.19', 'upperLimit': '11.77'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 12', 'description': "The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™ ; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex ECL using the PnECL v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.", 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include not vaccinated at week 8, vaccination out of window, blood draw out of window, prohibited concomitant medication or vaccine, violations of key inclusion/exclusion criteria, or missing serology results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'FG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Vaccinated on Day 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'Week 8', 'comment': 'Vaccinated with PNEUMOVAX™23', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '148'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Adults 18 years of age or older infected with human immunodeficiency virus (HIV) who did not receive a pneumococcal vaccine prior to study entry were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'BG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '41.3', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '41.9', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-01', 'size': 715023, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-02T15:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2018-03-22', 'resultsFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-02', 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1', 'timeFrame': 'Up to 5 days after Vaccination 1 (Up to Day 5)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1', 'timeFrame': 'Up to 14 days after Vaccination 1 (Up to Day 14)', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1', 'timeFrame': 'Day 1 up to 8 weeks after Vaccination 1 (Up to Week 8)', 'description': 'A serious adverse event (SAE) is an AE that 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. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1', 'timeFrame': 'Day 30', 'description': 'Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). This assay reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.'}, {'measure': 'Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1', 'timeFrame': 'Day 30', 'description': "The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2', 'timeFrame': 'Up to 5 days after Vaccination 2 (Up to Day 61)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2', 'timeFrame': 'Up to 14 days after Vaccination 2 (Up to Day 70)', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2', 'timeFrame': 'From Week 8 up to Month 6', 'description': 'A serious adverse event (SAE) is an AE that 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. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Geometric Mean Titer of Serotype-specific OPA After Vaccination 2', 'timeFrame': 'Week 12', 'description': 'Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA. The MOPA reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.'}, {'measure': 'Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2', 'timeFrame': 'Week 12', 'description': "The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™ ; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex ECL using the PnECL v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conjugate pneumococcal vaccine, 15-valent, 22F, 33F'], 'conditions': ['Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '34750291', 'type': 'RESULT', 'citation': 'Mohapi L, Pinedo Y, Osiyemi O, Supparatpinyo K, Ratanasuwan W, Molina JM, Dagan R, Tamms G, Sterling T, Zhang Y, Pedley A, Hartzel J, Kan Y, Hurtado K, Musey L, Simon JK, Buchwald UK; V114-018 (PNEU-WAY) study group. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV. AIDS. 2022 Mar 1;36(3):373-382. doi: 10.1097/QAD.0000000000003126.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female infected with human immunodeficiency virus (HIV) and Cluster of Differentiation 4+ (CD4+) cell count ≥50 cells/µL and plasma HIV ribonucleic acid (RNA) \\<50,000 copies/mL\n* Receiving combination anti-retroviral therapy (ART) for at least 6 weeks before enrollment with no intention of changing therapy for 3 months after randomization\n* Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of study vaccine.\n\nExclusion Criteria:\n\n* History of opportunistic infections within 12 months before the first study vaccination\n* History of non-infectious acquired immune deficiency syndrome-related illness such as Kaposi's sarcoma, wasting syndrome, or HIV-associated nephropathy\n* History of invasive pneumococcal disease\n* Known hypersensitivity to any vaccine component\n* Known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease\n* Coagulation disorder contraindicating intramuscular vaccination\n* History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n* Female participant: positive urine or serum pregnancy test\n* Prior administration of any pneumococcal vaccine\n* Received systemic corticosteroids for ≥14 consecutive days and have not completed within 30 days of enrollment\n* Received immunosuppressive therapy\n* Received a blood transfusion or blood products within 6 months of enrollment\n* Participated in another clinical study of an investigational product within 2 months of enrollment\n* Current user of recreational or illicit drugs or recent history of drug or alcohol abuse or dependence."}, 'identificationModule': {'nctId': 'NCT03480802', 'acronym': 'PNEU-WAY', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Adults Infected With HIV (PNEU-WAY)', 'orgStudyIdInfo': {'id': 'V114-018'}, 'secondaryIdInfos': [{'id': 'V114-018', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '2017-001909-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V114', 'description': 'Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)', 'interventionNames': ['Biological: V114', 'Biological: PNEUMOVAX™23']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevnar 13™', 'description': 'Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)', 'interventionNames': ['Biological: Prevnar 13™', 'Biological: PNEUMOVAX™23']}], 'interventions': [{'name': 'V114', 'type': 'BIOLOGICAL', 'description': '15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose', 'armGroupLabels': ['V114']}, {'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 (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose', 'armGroupLabels': ['Prevnar 13™']}, {'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, 19F, 19A, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose', 'armGroupLabels': ['Prevnar 13™', 'V114']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Bliss Healthcare Services ( Site 0010)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute, P.A. ( Site 0011)', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '77060', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Saint Hope Foundation, Inc. ( Site 0009)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Crofoot Research Center, Inc. ( Site 0002)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '63000', 'city': 'Clemont Ferrand', 'country': 'France', 'facility': 'Hopital Gabriel Montpied ( Site 0084)'}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Louis ( Site 0094)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin du Paris ( Site 0089)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '15001', 'city': 'Lima', 'country': 'Peru', 'facility': 'Via Libre ( Site 0043)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '15046', 'city': 'Lima', 'country': 'Peru', 'facility': 'Investigaciones Medicas en Salud - INMENSA ( Site 0041)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '1862', 'city': 'Johannesburg', 'state': 'Soweto', 'country': 'South Africa', 'facility': 'Chris Hani Baragwanath Hospital ( Site 0122)', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '7626', 'city': 'Paarl', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Be Part Yoluntu Centre ( Site 0123)', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hosp (Prev&Social Med). ( Site 0183)', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Research Institute for Health. ( Site 0182)', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}