Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-29 @ 9:23 AM
Study NCT ID:
NCT06436703
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2024-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study will be an observer-blinded and Sponsor-unblinded study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SSA - Percentage of Participants Reporting Local Reactions After Vaccination', 'timeFrame': 'From Day 1 Through at least Day 7 After Vaccination', 'description': 'Pain at the injection site, redness, and swelling.'}, {'measure': 'SSA - Percentage of Participants Reporting Systemic Events After Vaccination', 'timeFrame': 'From Day 1 Through at least Day 7 After Vaccination', 'description': 'Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.'}, {'measure': 'SSA - Percentage of Participants Reporting Adverse Events After Vaccination', 'timeFrame': 'From Day 1 Through 4 Weeks After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSB - Percentage of Participants Reporting Local Reactions After Vaccination', 'timeFrame': 'From Day 1 Through at least Day 7 After Vaccination', 'description': 'Pain at injection site, redness, and swelling.'}, {'measure': 'SSB - Percentage of Participants Reporting Systemic Events After Vaccination', 'timeFrame': 'From Day 1 Through at least Day 7 After Vaccination', 'description': 'Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.'}, {'measure': 'SSB - Percentage of Participants Reporting Adverse Events After Vaccination', 'timeFrame': 'From Day 1 Through 4 Weeks After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSB - Percentage of Participants Reporting Serious Adverse Events (SAE)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSC - Percentage of Participants Reporting Local Reactions After Vaccination', 'timeFrame': 'From Day 1 Through at least Day 7 After Vaccination', 'description': 'Pain at the injection site, redness, and swelling.'}, {'measure': 'SSC - Percentage of Participants Reporting Systemic Events After Vaccination', 'timeFrame': 'From Day 1 Through at least Day 7 After Vaccination', 'description': 'Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.'}, {'measure': 'SSC - Percentage of Participants Reporting Adverse Events After Vaccination', 'timeFrame': 'From Day 1 Through 4 Weeks After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSC - Percentage of Participants Reporting Serious Adverse Events (SAE)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}, {'measure': 'SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs)', 'timeFrame': 'From Day 1 Through 6 Months After Vaccination', 'description': 'As elicited by investigational site staff'}], 'secondaryOutcomes': [{'measure': 'SSA - HAI Geometric Mean Titers (GMTs) for each strain', 'timeFrame': '4 Weeks After Vaccination', 'description': 'As measured at the central laboratory'}, {'measure': 'SSA - HAI geometric mean fold rise (GMFR) for each strain', 'timeFrame': '4 Weeks After Vaccination', 'description': 'As measured at the central laboratory'}, {'measure': 'SSA - The proportion of participants achieving HAI seroconversion for each strain', 'timeFrame': '4 Weeks After Vaccination', 'description': 'As measured at the central laboratory'}, {'measure': 'SSA - The proportion of participants with HAI titers ≥1:40 for each strain', 'timeFrame': 'Baseline and 4 Weeks After Vaccination', 'description': 'As measured at the central laboratory'}, {'measure': 'SSB - HAI geometric mean titers (GMTs) for each strain', 'timeFrame': '4 Weeks After Vaccination', 'description': 'As measured at the central laboratory'}, {'measure': 'SSB - HAI geometric mean fold rise (GMFR) for each strain', 'timeFrame': '4 Weeks After Vaccination', 'description': 'As measured at the central laboratory'}, {'measure': 'SSB - The proportion of participants achieving HAI seroconversion for each strain', 'timeFrame': '4 Weeks After Vaccination', 'description': 'As measured at the central laboratory'}, {'measure': 'SSB - The proportion of participants with HAI titers ≥1:40 for each strain', 'timeFrame': 'Baseline and 4 Weeks After Vaccination', 'description': 'As measured at the central laboratory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza, Human']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4781013', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are:\n\n* safe; and\n* how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.\n\nRNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.\n\nInfluenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.\n\nThe study is seeking for participants who:\n\n* are at least 18 years of age\n* have not received an influenza vaccine within the last 6 months\n* are generally healthy\n\nThis study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).\n\nAll participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:\n\n* 1 of the modRNA influenza vaccines that is being studied; or\n* an approved influenza vaccine approved for use in their respective age group.\n\nParticipants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria\n\nApplies to all 3 substudies:\n\n* participants ≥18 years of age.\n* generally healthy participants.\n\nSubstudy C ONLY:\n\n\\- receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago.\n\nKey Exclusion Criteria\n\nAll 3 substudies:\n\n* diagnosis of influenza (by clinical testing) in the last 6 months.\n* immunocompromised individuals with known or suspected immunodeficiency\n* receipt of any investigational or licensed influenza vaccines within 6 months.'}, 'identificationModule': {'nctId': 'NCT06436703', 'briefTitle': 'A Study About Modified RNA Vaccines Against Influenza in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS', 'orgStudyIdInfo': {'id': 'C4781013'}, 'secondaryIdInfos': [{'id': 'NCT06436703', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSA: Influenza ModRNA Vaccine 2A', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSA: Influenza ModRNA Vaccine 3A', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSA: Influenza ModRNA Vaccine 4A', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSA: Influenza ModRNA Vaccine 5A', 'description': '\\- Single dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SSA: QIV1', 'description': '\\- Single dose on Day 1', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine (QIV)']}, {'type': 'EXPERIMENTAL', 'label': 'SSB: Influenza ModRNA Vaccine 3B', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSB: Influenza ModRNA Vaccine 4B', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSB: Influenza ModRNA Vaccine 5B', 'description': '\\- Single dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SSB: QIV2', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine (QIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SSB: QIV3', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine (QIV)']}, {'type': 'EXPERIMENTAL', 'label': 'SSC: Influenza ModRNA Vaccine 3C', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSC: Influenza ModRNA Vaccine 4C', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSC: Influenza ModRNA Vaccine 5C', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSC: Influenza ModRNA Vaccine 6C', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSC: Influenza ModRNA Vaccine 7C', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSC: Influenza ModRNA Vaccine 8C', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'SSC: Influenza ModRNA Vaccine 9C', 'description': '\\- Single dose on Day 1', 'interventionNames': ['Biological: Influenza ModRNA Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SSC: QIV2', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine (QIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SSC: QIV3', 'description': '\\- Single Dose on Day 1', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine (QIV)']}], 'interventions': [{'name': 'Influenza ModRNA Vaccine', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['SSA: Influenza ModRNA Vaccine 2A', 'SSA: Influenza ModRNA Vaccine 3A', 'SSA: Influenza ModRNA Vaccine 4A', 'SSA: Influenza ModRNA Vaccine 5A', 'SSB: Influenza ModRNA Vaccine 3B', 'SSB: Influenza ModRNA Vaccine 4B', 'SSB: Influenza ModRNA Vaccine 5B', 'SSC: Influenza ModRNA Vaccine 3C', 'SSC: Influenza ModRNA Vaccine 4C', 'SSC: Influenza ModRNA Vaccine 5C', 'SSC: Influenza ModRNA Vaccine 6C', 'SSC: Influenza ModRNA Vaccine 7C', 'SSC: Influenza ModRNA Vaccine 8C', 'SSC: Influenza ModRNA Vaccine 9C']}, {'name': 'Quadrivalent Influenza Vaccine (QIV)', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['SSA: QIV1', 'SSB: QIV2', 'SSB: QIV3', 'SSC: QIV2', 'SSC: QIV3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Headlands Research - Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06460', 'city': 'Milford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Clinical Research Consulting', 'geoPoint': {'lat': 41.22232, 'lon': -73.0565}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research & Health Center, Inc', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America ( Hollywood )', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Springs Community Health Center', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Headlands Research Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps-Mra, Llc', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East-West Medical Research Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism Research LLC dba Nucleus Network', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Research Professionals', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, LLC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Vaccine and Trials Unit', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'M3 Wake Research, Inc.', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'DM Clinical Research - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78526', 'city': 'Brownsville', 'state': 'Texas', 'country': 'United States', 'facility': 'Headlands Horizons LLC', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'SMS Clinical Research', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, LLC dba Flourish Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Dynamed Clinical Research, LP d/b/a DM Clinical Research', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Charlottesville Medical Research', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], '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'}}}}