Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05585632
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2022-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'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': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722747', 'term': 'mRNA-1010 influenza vaccine'}, {'id': 'C000722749', 'term': 'mRNA-1345 respiratory syncytial virus vaccine'}, {'id': 'C000722752', 'term': 'mRNA-1273.214 COVID-19 vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All participants will be unblinded at Day 29 (1 month following study injection) to seek immunization with licensed influenza and/or SARS-CoV-2 vaccines, outside of the study, per local standard of care.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2022-10-14', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)', 'timeFrame': 'Up to Day 8 (7 days post vaccination)'}, {'measure': 'Number of Participants with Unsolicited Adverse Events (AEs)', 'timeFrame': 'Up to Day 29 (28 days post vaccination)'}, {'measure': 'Number of Participants with Medically-Attended AEs (MAAEs)', 'timeFrame': 'Day 1 through Day 361'}, {'measure': 'Number of Participants with Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Day 1 through Day 361'}, {'measure': 'Number of Participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 through Day 361'}, {'measure': 'Number of Participants with AEs Leading to Discontinuation', 'timeFrame': 'Day 1 through Day 361'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29', 'timeFrame': 'Baseline (Day 1), Day 29'}, {'measure': 'Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29', 'timeFrame': 'Baseline (Day 1), Day 29'}, {'measure': 'Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29', 'timeFrame': 'Baseline (Day 1), Day 29'}, {'measure': 'Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29', 'timeFrame': 'Baseline (Day 1), Day 29'}, {'measure': 'Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29', 'timeFrame': 'Baseline (Day 1), Day 29'}, {'measure': 'Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29', 'timeFrame': 'Baseline (Day 1), Day 29'}, {'measure': 'Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay', 'timeFrame': 'Baseline (Day 1) to Day 29', 'description': 'Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is \\<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.'}, {'measure': 'SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)', 'timeFrame': 'Baseline (Day 1) to Day 29', 'description': 'Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4\\*LLOQ if baseline titer is \\<LLOQ in nAb titers measured by PsVNA (or binding antibody assay).'}, {'measure': 'RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay', 'timeFrame': 'Baseline (Day 1) to Day 29', 'description': 'Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥LLOQ or ≥4\\*LLOQ if baseline titer is \\<LLOQ in nAb titers measured by RSV neutralization assay.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mRNA-1230 Vaccine', 'mRNA-1045 Vaccine', 'SARS-CoV-2 Vaccine', 'Influenza Vaccine', 'RSV Vaccine', 'Coronavirus', 'Virus Diseases', 'Messenger RNA', 'COVID-19', 'COVID-19 Vaccine', 'Moderna'], 'conditions': ['SARS-CoV-2', 'Influenza', 'RSV']}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Investigator assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.\n* Body mass index of 18 to 35 kilograms/square meter (kg/m\\^2) (inclusive) at the Screening Visit(s).\n* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception or abstinence through 3 months following the vaccination, and not currently breastfeeding.\n* Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. The most recent COVID-19 vaccine (primary series or booster) must be ≥120 days before (or less per local guidance) Day 1.\n\nExclusion Criteria:\n\n* Acutely ill or febrile (temperature ≥38.0°Celsius/\\[100.4°Fahrenheit\\]) 72 hours before or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window for re-evaluation and will retain their initially assigned participant number.\n* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.\n* Has received systemic immunosuppressants or immune-modifying drugs for \\>14 days in total within 6 months before screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.\n* Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days before study injections (Day 1) or within 28 days after the study injection.\n* Received a licensed seasonal influenza vaccine or any other investigational influenza or RSV vaccine within ≤180 days before Day 1.\n* Tested positive for influenza or RSV by local health authority-approved testing methods within ≤180 days before Day 1.\n* Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the United States Center for Disease Control (CDC) or the European Centre for Disease Prevention and Control as a high risk (close contact) of a COVID-19 case or known history of SARS-CoV-2 infection within the past 90 days before Day 1.\n* Donated ≥450 mL of blood products within 28 days before the Screening Visit or plans to donate blood products during the study.\n\nNote: Other inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05585632', 'briefTitle': 'A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA-1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years of Age', 'orgStudyIdInfo': {'id': 'mRNA-1230-P101'}, 'secondaryIdInfos': [{'id': '2022-002138-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mRNA-1010', 'description': 'Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.', 'interventionNames': ['Biological: mRNA-1010']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1345', 'description': 'Participants will receive a dose of mRNA-1345 by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1345']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1273.214', 'description': 'Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1273.214']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1045 Dose Level A', 'description': 'Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1045']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1045 Dose Level B', 'description': 'Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1045']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1045 Dose Level C', 'description': 'Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1045']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1230 Dose Level A', 'description': 'Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1230']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1230 Dose Level B', 'description': 'Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1230']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1230 Dose Level C', 'description': 'Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1230']}], 'interventions': [{'name': 'mRNA-1010', 'type': 'BIOLOGICAL', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1010']}, {'name': 'mRNA-1345', 'type': 'BIOLOGICAL', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1345']}, {'name': 'mRNA-1273.214', 'type': 'BIOLOGICAL', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1273.214']}, {'name': 'mRNA-1045', 'type': 'BIOLOGICAL', 'description': 'Formulation for injection', 'armGroupLabels': ['mRNA-1045 Dose Level A', 'mRNA-1045 Dose Level B', 'mRNA-1045 Dose Level C']}, {'name': 'mRNA-1230', 'type': 'BIOLOGICAL', 'description': 'Formulation for injection', 'armGroupLabels': ['mRNA-1230 Dose Level A', 'mRNA-1230 Dose Level B', 'mRNA-1230 Dose Level C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research Sites', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America (cenexel)', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research Sites', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research - Family Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Centricity Research', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cenexel IRA (iResearch Atlanta)', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Optimal Research', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '48076', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'DM Clinical Research', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '28403', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Trial Management Associates', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Trial Management Associates', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'DM Clinical Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'DM Clinical Research', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Paratus Clinical Research Western Sydney', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '2259', 'city': 'Kanwal', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Paratus Clinical Kanwal', 'geoPoint': {'lat': -33.253, 'lon': 151.4911}}, {'zip': '4010', 'city': 'Albion', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Paratus Clinical Research Brisbane', 'geoPoint': {'lat': -27.43357, 'lon': 153.04449}}, {'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Nucleus Network Brisbane Clinic - Centre For Clinical Studies', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'University of the Sunshine Coast', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': 'QLD 4068', 'city': 'Taringa', 'state': 'Queensland', 'country': 'Australia', 'facility': 'AusTrials Taringa', 'geoPoint': {'lat': -27.49061, 'lon': 152.97861}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}, {'zip': 'NE2 4HH', 'city': 'Newcastle', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Newcastle University - Institute of Cellular Medicine (ICM)', 'geoPoint': {'lat': 52.43333, 'lon': -3.11667}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': "Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OX3 7LJ', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'University of Oxford', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'BS2 8BJ', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Royal Hospital for Children', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'EX25DW', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon & Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0RE', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's Healthcare NHS Trust - University of London - Th", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3GB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'National Hospital for Neurology and Neurosurgery', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ModernaTX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}