Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT05572658
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2022-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722749', 'term': 'mRNA-1345 respiratory syncytial virus vaccine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10994}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV', 'timeFrame': 'From Day 15 up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Length of Stay of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV', 'timeFrame': 'From Day 15 up to 1 year'}, {'measure': 'Mean Total Cost of Hospitalizations and Mean Total Healthcare Cost Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV', 'timeFrame': 'From Day 15 up to 1 year'}, {'measure': 'Number of Participants with Use of Mechanical Ventilation, Supplemental Oxygen, and Intensive Care Unit Admissions During Hospitalizations Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV', 'timeFrame': 'From Day 15 up to 1 year'}, {'measure': 'Number of Participants with Antibiotic or Corticosteroid Treatment', 'timeFrame': 'From Day 15 up to 1 year'}, {'measure': 'Number of Participants with Chronic Obstructive Pulmonary Disease (COPD), Congestive heart failure (CHF), and Asthma', 'timeFrame': 'From Day 15 up to 1 year'}, {'measure': 'Number of Participants with First Incidence of Asthma, COPD, and CHF Exacerbations', 'timeFrame': 'From Day 15 up to 1 year'}]}, 'conditionsModule': {'keywords': ['Viral Diseases', 'Messenger RNA', 'Moderna', 'mRNA-1345', 'Effectiveness', 'Vaccines'], 'conditions': ['Respiratory Syncytial Virus']}, 'descriptionModule': {'briefSummary': 'The main goal of this observational study is to describe the health and economic outcomes associated with use of the Moderna mRNA-1345 vaccine.', 'detailedDescription': 'This study will evaluate real-world data (RWD) and data from eligible United States (US) based participants from Study mRNA-1345-P301 (NCT05127434) for additional health and economic outcomes such as hospitalizations, healthcare resource utilization, disease exacerbations, and costs, associated with usage of the mRNA-1345 vaccine. The results from the current study (mRNA-1345-P901) are intended to complement the results from the mRNA-1345-P301 study. No interventions will be administered during the current study (mRNA-1345-P901).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population of interest will include P301 participants randomized in the US who provide informed consent and meet eligibility criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nP901 inclusion criteria:\n\n* Must be a participant in P301\n* Must be based in the US\n* Must provide informed consent for P901\n\nP301 key inclusion criteria:\n\n* Adults who are primarily responsible for self-care and activities of daily living.\n* Participants may have one or more chronic medical diagnoses (specifically chronic heart failure and chronic obstructive pulmonary disease) but should be medically stable in the opinion of the investigator.\n* Body mass index from ≥18 kilograms (kg)/square meter (m\\^2) to ≤35 kg/m\\^2.\n\nExclusion Criteria:\n\nP901 exclusion criteria:\n\n* Receipt of any future licensed RSV vaccine at baseline.\n* Receipt of any future licensed RSV vaccines during the study follow-up period will result in censorship on the date the vaccine was received.\n\nAll inclusion and exclusion criteria from P301 that are available in the RWD will be applied to the RWD controls, if built.\n\nP301 key exclusion criteria:\n\n* Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.\n* Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).\n* History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.\n* Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection. The exceptions are seasonal influenza vaccines, pneumococcal vaccines, or authorized or approved vaccines for the prevention of COVID-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the Day 1 study injection. Efforts should be made to space study injection and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.\n\nOther inclusion and/or exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05572658', 'acronym': 'ROSE', 'briefTitle': 'Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'mRNA-1345-P901 Study: RSV Outcomes Study Extension', 'orgStudyIdInfo': {'id': 'mRNA-1345-P901'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mRNA-1345: Exposed', 'description': 'Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.', 'interventionNames': ['Biological: mRNA-1345']}, {'label': 'Placebo/Control: Referent', 'description': 'Eligible US participants from the P301 study who received placebo.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'mRNA-1345', 'type': 'BIOLOGICAL', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1345: Exposed']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% sodium chloride (normal saline) injection', 'armGroupLabels': ['Placebo/Control: Referent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209-6898', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Accel Research Site - 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