Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-28 @ 4:16 AM
Study NCT ID:
NCT06821061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D000086382', 'term': 'COVID-19'}], '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'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2645}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants reporting prompted local reactions within 7 days following investigational product administration', 'timeFrame': 'Day 7'}, {'measure': 'Percentage of participants reporting prompted systemic events within 7 days following investigational product administration', 'timeFrame': 'Day 7'}, {'measure': 'Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration', 'timeFrame': '1 month'}, {'measure': 'Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'GMTs before and through 1 month following investigational product administration', 'timeFrame': 'Before vaccination through to 1 month after vaccination'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza', 'COVID-19 (Coronavirus Disease 2019)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C6271001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together.\n\nThis study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Participants 18 years of age or older\n* Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study\n\nExclusion criteria:\n\n* Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment\n* Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment.\n* Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1.\n\nRefer to the study contact for further eligibility details'}, 'identificationModule': {'nctId': 'NCT06821061', 'briefTitle': 'A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioNTech SE'}, 'officialTitle': 'A PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS', 'orgStudyIdInfo': {'id': 'C6271001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Low Dose COVID-19 Vaccine (1a)', 'interventionNames': ['Biological: Investigational COVID-19 Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Low Dose COVID-19 Vaccine ( 1b)', 'interventionNames': ['Biological: Investigational COVID-19 Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'Low Dose COVID-19 Vaccine ( 1c)', 'interventionNames': ['Biological: Investigational COVID-19 Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm E', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm F', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm G', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm H', 'description': 'Licensed COVID-19 Vaccine', 'interventionNames': ['Biological: Licensed COVID-19 Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I', 'description': 'Licensed Influenza Vaccine (1)', 'interventionNames': ['Biological: Licensed Influenza Vaccine 1']}, {'type': 'EXPERIMENTAL', 'label': 'Arm J', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm K', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm L', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm M', 'description': 'Licensed COVID-19 Vaccine', 'interventionNames': ['Biological: Licensed COVID-19 Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm N', 'description': 'Licensed Influenza Vaccine (2)', 'interventionNames': ['Biological: Licensed Influenza Vaccine 2']}, {'type': 'EXPERIMENTAL', 'label': 'Arm AA', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm BB', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm CC', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm DD', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm EE', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm FF', 'description': 'Licensed COVID-19 Vaccine', 'interventionNames': ['Biological: Licensed COVID-19 Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm GG', 'description': 'Licensed Influenza Vaccine (3)', 'interventionNames': ['Biological: Licensed Influenza Vaccine 3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm HH', 'description': 'Licensed Influenza Vaccine (2)', 'interventionNames': ['Biological: Licensed Influenza Vaccine 2']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Low Dose COVID-19 Vaccine ( 1b)', 'interventionNames': ['Biological: Investigational COVID-19 Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm JJ', 'description': 'Low Dose COVID-19 Vaccine ( 1c)', 'interventionNames': ['Biological: Investigational COVID-19 Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm KK', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm LL', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm MM', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm NN', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm OO', 'description': 'Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)', 'interventionNames': ['Combination Product: Investigational Influenza and COVID-19 Combination Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm PP', 'description': 'Medium Dose Investigational Influenza Vaccine (1)', 'interventionNames': ['Biological: Investigational Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm QQ', 'description': 'High Dose Investigational Influenza Vaccine (2)', 'interventionNames': ['Biological: Investigational Influenza Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm RR', 'description': 'Licensed COVID-19 Vaccine', 'interventionNames': ['Biological: Licensed COVID-19 Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm SS', 'description': 'Licensed Influenza Vaccine (3)', 'interventionNames': ['Biological: Licensed Influenza Vaccine 3']}], 'interventions': [{'name': 'Investigational Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'Investigational Influenza Vaccine', 'armGroupLabels': ['Arm PP', 'Arm QQ']}, {'name': 'Investigational COVID-19 Vaccine', 'type': 'BIOLOGICAL', 'description': 'Investigational COVID-19 Vaccine', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm II', 'Arm JJ']}, {'name': 'Investigational Influenza and COVID-19 Combination Vaccine', 'type': 'COMBINATION_PRODUCT', 'description': 'Investigational Combined Influenza and COVID-19 Vaccine', 'armGroupLabels': ['Arm AA', 'Arm BB', 'Arm CC', 'Arm D', 'Arm DD', 'Arm E', 'Arm EE', 'Arm F', 'Arm G', 'Arm J', 'Arm K', 'Arm KK', 'Arm L', 'Arm LL', 'Arm MM', 'Arm NN', 'Arm OO']}, {'name': 'Licensed Influenza Vaccine 1', 'type': 'BIOLOGICAL', 'description': 'Licensed Influenza Vaccine 1', 'armGroupLabels': ['Arm I']}, {'name': 'Licensed Influenza Vaccine 2', 'type': 'BIOLOGICAL', 'description': 'Licensed Influenza Vaccine 2', 'armGroupLabels': ['Arm HH', 'Arm N']}, {'name': 'Licensed Influenza Vaccine 3', 'type': 'BIOLOGICAL', 'description': 'Licensed Influenza Vaccine 3', 'armGroupLabels': ['Arm GG', 'Arm SS']}, {'name': 'Licensed COVID-19 Vaccine', 'type': 'BIOLOGICAL', 'description': 'Pfizer-BioNTech COVID-19 Vaccine', 'armGroupLabels': ['Arm FF', 'Arm H', 'Arm M', 'Arm RR']}]}, 'contactsLocationsModule': {'locations': [{'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': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'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': '33172', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research & Health Center, Inc', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Dade Medical Research Institute, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Springs Community Health Center', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Atlanta', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East-West Medical Research Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Research Professionals', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '89030', 'city': 'North Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Las Vegas Clinical Trials', 'geoPoint': {'lat': 36.19886, 'lon': -115.1175}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Global Health Institute', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28403', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Trial Management Associates - Wilmington - Floral Parkway', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Centricity Research Columbus Ohio Multispecialty', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'DM Clinical Research - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29405', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'AMR Clinical', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'AMR Clinical', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Associates Inc', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78526', 'city': 'Brownsville', 'state': 'Texas', 'country': 'United States', 'facility': 'Headlands Horizons, LLC dba Headlands Research-Brownsville', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '77065', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'DM Clinical Research- Cyfair', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'SMS Clinical Research', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'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': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Washington Health Research Institute (KPWHRI)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioNTech SE', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}