Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-04-11 @ 3:15 AM
Study NCT ID:
NCT00560950
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2007-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
Sponsor:
Organization:
Raw JSON
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Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Open-label non-randomized group of subjects enrolled in this extension. Subjects recruited from original study which completed five years previously.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1st Revaccination Group', 'description': 'Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase', 'otherNumAffected': 48, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2nd Revaccination Group', 'description': 'Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase', 'otherNumAffected': 60, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Aphthous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oral Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Erythema', 'stats': [{'groupId': 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'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Joint Range of Motion Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus Generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3', 'denoms': [{'units': 'Participants', 'counts': 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Day 1'}, {'id': 'OG003', 'title': '2nd Revaccination Group Day 30'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '12.2'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '24.0'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '13.0'}, {'value': '17.2', 'groupId': 'OG003', 'lowerLimit': '13.3', 'upperLimit': '22.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.', 'unitOfMeasure': 'gpELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1st Revaccination Group Day 1'}, {'id': 'OG001', 'title': '1st Revaccination Group Day 30'}, {'id': 'OG002', 'title': '2nd Revaccination Group Day 1'}, {'id': 'OG003', 'title': '2nd Revaccination Group Day 30'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.6'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '7.1'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '3.8'}, {'value': '5.6', 'groupId': 'OG003', 'lowerLimit': '3.8', 'upperLimit': '8.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.', 'unitOfMeasure': 'gpELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1st Revaccination Group', 'description': 'Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase'}, {'id': 'FG001', 'title': '2nd Revaccination Group', 'description': 'Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a Phase III study. The first patient was enrolled (FPE) on 13-Jul-2007. The last patient last visit (LPLV) was on 30-May-2008. A total of 5 US study centers were involved in the recruitment.', 'preAssignmentDetails': 'Base trial 4/97-4/98 Prior to results posted Initial: subjects received 1st or 2nd dose of PN23 Persistence: followed immune response 5 yrs; ended 4/03 Extension 7/07-4/08: enrolled 9-10 yrs after base. 1dose of PN23 Blood drawn Days 1\\&30, immune response to 8 serotypes measured 143 of 400 enrolled: difficulty enrolling eligible/interested subjects'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1st Revaccination Group', 'description': 'Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase'}, {'id': 'BG001', 'title': '2nd Revaccination Group', 'description': 'Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '93'}, {'value': '77.1', 'groupId': 'BG001', 'lowerLimit': '60', 'upperLimit': '88'}, {'value': '75.8', 'groupId': 'BG002', 'lowerLimit': '60', 'upperLimit': '93'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2007-11-19', 'resultsFirstSubmitDate': '2009-03-30', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-30', 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.'}, {'measure': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.'}, {'measure': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the\n\nextension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.'}, {'measure': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the\n\nextension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.'}, {'measure': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.'}, {'measure': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.'}, {'measure': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.'}, {'measure': 'Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F', 'timeFrame': 'Day 1 & Day 30', 'description': 'Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.'}]}, 'conditionsModule': {'conditions': ['Pneumococcal Infection']}, 'referencesModule': {'references': [{'pmid': '21860256', 'type': 'RESULT', 'citation': 'Musher DM, Manoff SB, McFetridge RD, Liss CL, Marchese RD, Raab J, Rueda AM, Walker ML, Hoover PA. Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults. Hum Vaccin. 2011 Sep;7(9):919-28. doi: 10.4161/hv.7.9.15996. Epub 2011 Sep 1.'}, {'pmid': '20088694', 'type': 'RESULT', 'citation': 'Manoff SB, Liss C, Caulfield MJ, Marchese RD, Silber J, Boslego J, Romero-Steiner S, Rajam G, Glass NE, Whitney CG, Carlone GM. Revaccination with a 23-valent pneumococcal polysaccharide vaccine induces elevated and persistent functional antibody responses in adults aged 65 > or = years. J Infect Dis. 2010 Feb 15;201(4):525-33. doi: 10.1086/651131.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.', 'detailedDescription': 'This study is an extension study (V110-007-10) which met requirements for posting on clinicaltrials.gov. The original study (V110-007-00) was completed in 2004 and did not meet the criteria for registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '59 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal or negative urine pregnancy test if female\n* No fever on the day of vaccination\n\nExclusion Criteria:\n\n* History of allergy to vaccine components\n* History of pneumococcal disease\n* Received any live virus vaccination within 4 weeks prior to study start\n* Received any inactivated vaccination within 7 days prior to study start\n* Received any blood products within 5 months prior to study start\n* Participated in an investigational drug or vaccine study in the past 30 days\n* Received immunosuppressive therapy\n* Patient has an immune deficiency'}, 'identificationModule': {'nctId': 'NCT00560950', 'briefTitle': 'Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Open-Label Study of the Safety, Tolerability, and Immunogenicity of Revaccination With PNEUMOVAX(TM) 23 Vaccine (Pneumococcal Vaccine Polyvalent, Merck & Co., Inc.) in Older Adults', 'orgStudyIdInfo': {'id': 'V110-007'}, 'secondaryIdInfos': [{'id': '2007_540'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1st Revaccination Group', 'interventionNames': ['Biological: pneumococcal 23v polysaccharide vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2nd Revaccination Group', 'interventionNames': ['Biological: pneumococcal 23v polysaccharide vaccine']}], 'interventions': [{'name': 'pneumococcal 23v polysaccharide vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['V110', 'PNEUMOVAX'], 'description': 'Duration of Treatment: Single vaccination on Day 1', 'armGroupLabels': ['1st Revaccination Group', '2nd Revaccination Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}