Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT05329259
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
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'}]}}, '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': {'timeFrame': 'Within 1 month after vaccination.', 'description': 'The same event may appear as both an AE and an 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. The safety population were participants who received study intervention and had safety data assessed after vaccination.', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC', 'description': 'Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 1, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA v25.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.'}], 'classes': [{'title': 'Redness', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.3'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '10.9'}]}]}, {'title': 'Pain at Injection Site', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '69.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 Days After Vaccination', 'description': 'From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, local reactions including redness, swelling, and pain at the injection site were assessed and recorded.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study intervention and had safety data assessed after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '6.4'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '31.6'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '29.5'}]}]}, {'title': 'Joint Pain', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '12.1'}]}]}, {'title': 'Muscle Pain', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '38.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 Days After Vaccination', 'description': 'From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, systemic events including fever, headache, fatigue, muscle pain, and joint pain were assessed and recorded. Fever was defined as temperature ≥38.0 °C.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study intervention and had safety data assessed after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 Month After Vaccination', 'description': 'An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local reactions (redness, swelling, and pain at the injection site) and systemic events (fever, headache, fatigue, muscle pain, and joint pain) were not collected as AEs.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study intervention and had safety data assessed after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 Month After Vaccination', 'description': 'An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study intervention and had safety data assessed after vaccination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': 'Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.'}], 'periods': [{'title': 'Vaccination Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '1-Month Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in India. Participants took part in the study for approximately 1 month.', 'preAssignmentDetails': 'A total of 200 participants were enrolled and vaccinated, all participants completed the 1-month follow-up after vaccination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': 'Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '7.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race_Asian', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}]}]}, {'title': 'Ethnicity_Non-Hispanic/Non-Latino', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received any study intervention and had safety data assessed after vaccination.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-15', 'size': 837802, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-21T11:53', 'hasProtocol': True}, {'date': '2022-04-08', 'size': 308315, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-21T11:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2022-04-07', 'resultsFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-21', 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination', 'timeFrame': 'Within 7 Days After Vaccination', 'description': 'From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, local reactions including redness, swelling, and pain at the injection site were assessed and recorded.'}, {'measure': 'Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination', 'timeFrame': 'Within 7 Days After Vaccination', 'description': 'From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, systemic events including fever, headache, fatigue, muscle pain, and joint pain were assessed and recorded. Fever was defined as temperature ≥38.0 °C.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination', 'timeFrame': 'Within 1 Month After Vaccination', 'description': 'An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local reactions (redness, swelling, and pain at the injection site) and systemic events (fever, headache, fatigue, muscle pain, and joint pain) were not collected as AEs.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination', 'timeFrame': 'Within 1 Month After Vaccination', 'description': 'An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1851214', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '* The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India.\n* This study is seeking participants who are generally healthy adults ≥18 and \\<50 years of age, with no prior history of pneumococcal vaccination.\n* Participants will take part in the study for approximately one month which includes two visits to the study clinic.\n* Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Generally healthy participants between the ages of ≥18 and \\<50 years at the time of consent.\n* Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.\n\nExclusion Criteria:\n\n* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, or to any other diphtheria toxoid-containing vaccine.\n* Congenital, functional, or surgical asplenia.\n* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation."}, 'identificationModule': {'nctId': 'NCT05329259', 'briefTitle': 'A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 TO 49 YEARS OF AGE IN INDIA', 'orgStudyIdInfo': {'id': 'B1851214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '13-valent pneumococcal conjugate vaccine', 'description': 'Pneumococcal conjugate vaccine (13vPnC)', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine']}], 'interventions': [{'name': '13-valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': 'One dose of 13vPnC (0.5mL) will be administered intramuscularly.', 'armGroupLabels': ['13-valent pneumococcal conjugate vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '395002', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Nirmal Hospital Pvt Ltd.', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '560060', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'BGS Global Institute of Medical Sciences (BGSGIMS)', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '305001', 'city': 'Ajmer', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Jawahar Lal Nehru Medical College', 'geoPoint': {'lat': 26.4521, 'lon': 74.63867}}, {'zip': '700073', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Calcutta School of Tropical Medicine', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '110075', 'city': 'Delhi', 'country': 'India', 'facility': 'Aakash Healthcare Private Limited', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}