Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01509105
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2011-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prevenar13 Post Market Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, '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': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.', 'otherNumAtRisk': 649, 'otherNumAffected': 165, 'seriousNumAtRisk': 649, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'INJECTION SITE RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'INJECTION SITE REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'CRYING ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'FEVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'ENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'GASTRO-INTESTINAL DISORDER NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'EAR ACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'LIGAMENT DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'NAEVUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'NERVOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'ANAEMIA HYPOCHROMIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'CYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'FURUNCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'INFECTION VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'OTITIS MEDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'COUGHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'SPUTUM DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'DERMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'DERMATITIS CONTACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'SEBORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'SKIN DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'HETEROPHORIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'LACRIMAL DUCT OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}], 'seriousEvents': [{'term': 'MEDICINE INEFFECTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART 092'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "number of participants analyzed" (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days after Vaccination 4', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 3', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days after Vaccination 4', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.21', 'spread': '6.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 28 days after last dose of study vaccination (13 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who had at least 1 adverse event.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'After Vaccination 1: Mild (n =640)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 1: Moderate (n =640)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 1: Severe (n =640)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 2: Mild (n =536)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 2: Moderate (n =536)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 2: Severe (n =536)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 3: Mild (n =489)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 3: Moderate (n =489)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 3: Severe (n =489)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 4: Mild (n =342)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 4: Moderate (n =342)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'After Vaccination 4: Severe (n =342)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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Here, "n" signifies those participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Outcome in Response to Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No-resolved', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose of study vaccination (13 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose of study vaccination (13 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '649'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '649'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Prevenar 13', 'description': 'Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Mean Age', 'categories': [{'measurements': [{'value': '4.26', 'spread': '12.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '321', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '328', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 649}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2011-09-30', 'resultsFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-20', 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1', 'timeFrame': 'Within 7 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2', 'timeFrame': 'Within 7 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3', 'timeFrame': 'Within 7 days after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4', 'timeFrame': 'Within 28 days after Vaccination 4', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1', 'timeFrame': 'Within 7 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2', 'timeFrame': 'Within 7 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3', 'timeFrame': 'Within 7 days after Vaccination 3', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4', 'timeFrame': 'Within 28 days after Vaccination 4', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.'}], 'secondaryOutcomes': [{'measure': 'Duration of Adverse Events (AEs)', 'timeFrame': 'Baseline up to 28 days after last dose of study vaccination (13 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.'}, {'measure': 'Number of Participants With Adverse Events (AEs) by Severity', 'timeFrame': 'Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).'}, {'measure': 'Number of Participants With Outcome in Response to Adverse Events (AEs)', 'timeFrame': 'Baseline up to 28 days after last dose of study vaccination (13 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'."}, {'measure': 'Number of Participants Discontinued Due to Adverse Events', 'timeFrame': 'Baseline up to 28 days after last dose of study vaccination (13 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6096A1-4029&StudyName=Prevenar13%20post%20market%20surveillance', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.', 'detailedDescription': 'non-randomization, non-probability sampling'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).\n\nExclusion Criteria:\n\n* Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.'}, 'identificationModule': {'nctId': 'NCT01509105', 'briefTitle': 'Prevenar13 Post Market Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Post Marketing Surveillance To Observe Safety Of Prevenar 13', 'orgStudyIdInfo': {'id': '6096A1-4029'}, 'secondaryIdInfos': [{'id': 'B1851057', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1', 'interventionNames': ['Biological: 13-valent pneumococcal vaccine']}], 'interventions': [{'name': '13-valent pneumococcal vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Prevenar 13'], 'description': '0.5mL IM (Intramuscular administration) as per recommended schedule', 'armGroupLabels': ['Group1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220-956', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': "Choi's Pediatric Clinic", 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '447-804', 'city': 'Osan', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "Seoul Children's Hospital", 'geoPoint': {'lat': 37.15222, 'lon': 127.07056}}, {'zip': '463-821', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Bundang Pediatric Clinic', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '443-471', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Teun Teun Pediatric clinic', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '482-050', 'city': 'Yangju', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "Namujungwon Women's Hospital", 'geoPoint': {'lat': 37.83311, 'lon': 127.06169}}, {'zip': '448-508', 'city': 'Yongin-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Yonsei Pediatric Clinic', 'geoPoint': {'lat': 37.29686, 'lon': 127.08042}}, {'zip': '602-739', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Busan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '701847', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Jaeil Alliance Pediatrics Clinic', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '702886', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Teun Teun Pediatric Clinic', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '302-799', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Eulji University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '425-707', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '463-712', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Cha Bundang Medical Center, Cha University', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '402-852', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Lee Ha Young Pediatrics', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-711', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '613-806', 'city': 'Suyeong-gu', 'country': 'South Korea', 'facility': "JaMo Women's Hospital"}, {'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}