Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-01 @ 12:08 AM
Study NCT ID:
NCT01396434
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2011-06-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
Sponsor:
Organization:
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': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "The use of 13vPnC was based on the investigator's clinical judgment and was assumed to be consistent with the product's approved label."}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC (Prevenar 13), Cohort 1', 'description': 'Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.', 'otherNumAtRisk': 2817, 'otherNumAffected': 68, 'seriousNumAtRisk': 2817, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '13vPnC (Prevenar 13), Cohort 2', 'description': '13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.', 'otherNumAtRisk': 175, 'otherNumAffected': 5, 'seriousNumAtRisk': 175, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '13vPnC (Prevenar 13), Cohort 3', 'description': '13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Vaccination complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}], 'seriousEvents': [{'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2817, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO Drug Dictionary'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2817', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC (Prevenar 13), Cohort 1', 'description': 'Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.'}, {'id': 'OG001', 'title': '13vPnC (Prevenar 13), Cohort 2', 'description': '13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.'}, {'id': 'OG002', 'title': '13vPnC (Prevenar 13), Cohort 3', 'description': '13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period', 'description': 'All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of 13vPnC.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC (Prevenar 13), Cohort 1', 'description': 'Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.'}, {'id': 'FG001', 'title': '13vPnC (Prevenar 13), Cohort 2', 'description': '13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.'}, {'id': 'FG002', 'title': '13vPnC (Prevenar 13), Cohort 3', 'description': '13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2817'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2806'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2817', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '3006', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC (Prevenar 13), Cohort 1', 'description': 'Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.'}, {'id': 'BG001', 'title': '13vPnC (Prevenar 13), Cohort 2', 'description': '13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.'}, {'id': 'BG002', 'title': '13vPnC (Prevenar 13), Cohort 3', 'description': '13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age at enrollment (years)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.94', 'groupId': 'BG000'}, {'value': '65.1', 'spread': '10.60', 'groupId': 'BG001'}, {'value': '0.7', 'spread': '1.54', 'groupId': 'BG002'}, {'value': '4.3', 'spread': '15.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1402', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1523', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1415', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '1483', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2783', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '2972', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received at least 1 dose of 13vPnC.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3006}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2011-06-22', 'resultsFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2011-07-15', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-05', 'studyFirstPostDateStruct': {'date': '2011-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period', 'description': 'All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pneumococcal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1851076&StudyName=Safety%20Surveillance%20of%20Pneumococcal%2013-valent%20Conjugate%20Vaccine%20Among%20Filipinos', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Prevenar 13 is safe for administration to Filipinos.', 'detailedDescription': 'Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Filipino patients prescribed with the vaccine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients prescribed with the vaccine\n\nExclusion Criteria:\n\nPatients with hypersensitivity to the vaccine'}, 'identificationModule': {'nctId': 'NCT01396434', 'briefTitle': 'Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study', 'orgStudyIdInfo': {'id': 'B1851076'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prevenar 13 patients', 'interventionNames': ['Biological: Prevenar 13']}], 'interventions': [{'name': 'Prevenar 13', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumococcal 13-valent Conjugate Vaccine (13vPnC)'], 'description': 'Prevenar 13 vaccine as prescribed by the physician based on approved product indication', 'armGroupLabels': ['Prevenar 13 patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lipa City', 'state': 'Batangas', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 13.9411, 'lon': 121.1631}}, {'city': 'Tagbilaran City', 'state': 'Bohol', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 9.65556, 'lon': 123.85219}}, {'city': 'Malolos', 'state': 'Bulacan', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 14.8443, 'lon': 120.81039}}, {'zip': '6000', 'city': 'Cebu', 'state': 'Cebu', 'country': 'Philippines', 'facility': 'Cebu Doctor University Hospital', 'geoPoint': {'lat': 16.75187, 'lon': 121.5961}}, {'city': 'Bacolod City', 'state': 'Negros Occidental', 'country': 'Philippines', 'facility': "Room 220 The Doctor's Hospital, Inc.", 'geoPoint': {'lat': 10.66667, 'lon': 122.95}}, {'city': 'San Carlos City', 'state': 'Negros Occidental', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 15.92941, 'lon': 120.34863}}, {'city': 'San Carlos City', 'state': 'Negros Occidental', 'country': 'Philippines', 'facility': "San Carlos Doctor's Hospital", 'geoPoint': {'lat': 15.92941, 'lon': 120.34863}}, {'city': 'Victorias City', 'state': 'Negros Occidental', 'country': 'Philippines', 'facility': 'Victorias Commercial Center', 'geoPoint': {'lat': 10.90154, 'lon': 123.0705}}, {'city': 'Dagupan', 'state': 'Pangasinan', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 16.04313, 'lon': 120.33325}}, {'city': 'Mangaldan', 'state': 'Pangasinan', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 16.07, 'lon': 120.4025}}, {'city': 'Pozorrubio', 'state': 'Pangasinan', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 16.111, 'lon': 120.544}}, {'city': 'Angeles City', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 15.15, 'lon': 120.58333}}, {'city': 'Antipolo City', 'country': 'Philippines', 'facility': 'Private Clinic', 'geoPoint': {'lat': 14.62578, 'lon': 121.12251}}, {'zip': '6100', 'city': 'Bacolod City', 'country': 'Philippines', 'facility': 'Dr. Pablo O. 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