Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 8:46 PM
Study NCT ID:
NCT05127434
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2021-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
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': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36814}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)', 'timeFrame': 'Up to 7 days after each injection'}, {'measure': 'Number of Participants with Unsolicited Adverse Events (AEs)', 'timeFrame': 'Up to 28 days after each injection'}, {'measure': 'Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal', 'timeFrame': 'Up to BD Day 181'}, {'measure': 'Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms', 'timeFrame': 'From 14 days postinjection up to 12 months postinjection', 'description': 'VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100\\*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).'}, {'measure': 'VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms', 'timeFrame': 'From 14 days postinjection up to 12 months postinjection', 'description': 'VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100\\*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).'}, {'measure': 'Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies', 'timeFrame': 'BD Day 29'}, {'measure': 'Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose', 'timeFrame': 'BD Day 29'}], 'secondaryOutcomes': [{'measure': 'VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD)', 'timeFrame': 'From 14 days postinjection up to 12 months postinjection', 'description': 'VE of mRNA-1345 to prevent RT-PCR confirmed protocol-defined RSV-ARD, defined as 100\\*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).'}, {'measure': 'VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD', 'timeFrame': 'From 14 days postinjection up to 12 months postinjection', 'description': 'VE of mRNA-1345 to prevent first hospitalization associated with RSV-ARD or RSV-LRTD, defined as 100\\*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).'}, {'measure': 'GMT of Serum RSV Neutralizing Antibodies', 'timeFrame': 'Baseline through up to 24 months postinjection'}, {'measure': 'Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies', 'timeFrame': 'Baseline through up to 24 months postinjection'}, {'measure': 'Seroresponse Rate in RSV Neutralizing Antibodies', 'timeFrame': 'Baseline through up to 24 months postinjection'}, {'measure': 'Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers', 'timeFrame': 'Baseline through up to 24 months postinjection'}, {'measure': 'Proportion of Participants with ≥4-fold Increases in Antibody Titers from Baseline', 'timeFrame': 'Baseline through up to 24 months postinjection'}, {'measure': 'Seroresponse Rate (SRR) Difference Between Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose', 'timeFrame': 'BD Day 29'}, {'measure': 'GMT of Serum RSV-A and RSV-B Neutralizing Antibodies', 'timeFrame': 'BD Day 1 and Day 181'}, {'measure': 'GMFR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)', 'timeFrame': 'Baseline, BD Day 1, Day 29 and Day 181'}, {'measure': 'SRR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)', 'timeFrame': 'Baseline, BD Day 1, Day 29 and Day 181'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Viral Diseases', 'Messenger RNA', 'Moderna', 'mRNA-1345', 'Respiratory syncytial virus', 'Safety', 'Vaccines'], 'conditions': ['Respiratory Syncytial Virus']}, 'referencesModule': {'references': [{'pmid': '38889247', 'type': 'DERIVED', 'citation': 'Goswami J, Baqui AH, Doreski PA, Perez Marc G, Jimenez G, Ahmed S, Zaman K, Duncan CJA, Ujiie M, Ramet M, Perez-Breva L, Lan L, Du J, Kapoor A, Mehta S, Tomassini JE, Huang W, Zhou H, Stoszek SK, Priddy F, Lin N, Le Cam N, Shaw CA, Slobod K, Wilson E, Miller JM, Das R. Humoral Immunogenicity of mRNA-1345 RSV Vaccine in Older Adults. J Infect Dis. 2024 Nov 15;230(5):e996-e1006. doi: 10.1093/infdis/jiae316.'}, {'pmid': '38091530', 'type': 'DERIVED', 'citation': 'Wilson E, Goswami J, Baqui AH, Doreski PA, Perez-Marc G, Zaman K, Monroy J, Duncan CJA, Ujiie M, Ramet M, Perez-Breva L, Falsey AR, Walsh EE, Dhar R, Wilson L, Du J, Ghaswalla P, Kapoor A, Lan L, Mehta S, Mithani R, Panozzo CA, Simorellis AK, Kuter BJ, Schodel F, Huang W, Reuter C, Slobod K, Stoszek SK, Shaw CA, Miller JM, Das R, Chen GL; ConquerRSV Study Group. Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. N Engl J Med. 2023 Dec 14;389(24):2233-2244. doi: 10.1056/NEJMoa2307079.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.\n\nThe main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.', 'detailedDescription': 'The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Part A Phase 2 segment, up to 2,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.\n\nIn the Part A Phase 3 segment, approximately 35,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.\n\nIn the Part B substudy, 1500 participants who received a dose of mRNA-1345 in Part A Phase 3 will be randomly assigned in a 2:1 randomization ratio to receive a single BD injection of either mRNA-1345 at the selected dose or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria (Part A):\n\n* Adults ≥ 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (including chronic heart failure \\[CHF\\] and chronic obstructive pulmonary disease \\[COPD\\]), but should be medically stable\n* Body mass index from ≥18 kilograms (kg)/square meter (m\\^2) to ≤35 kg/m\\^2\n\nKey Inclusion Criteria (Part B):\n\n* Randomized to and were subsequently vaccinated with the mRNA-1345 study injection in Part A at least 21 months prior to Screening.\n\nKey Exclusion Criteria (Part A):\n\n* Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the Day 1 study injection.\n* Current participation in research involving receipt of any investigational RSV product\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.\n\nKey Exclusion Criteria (Part B):\n\n* Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of BD study injection (BD Day 1).\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 (including authorized or approved vaccines for the prevention of coronavirus disease 2019 (COVID-19) regardless of type of vaccine) within 14 days before or after the BD Day 1 study injection.\n* Received or plans to receive any commercial RSV vaccination at any time prior to BD study injection (BD Day 1) or during the substudy.\n\nOther inclusion and/or exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05127434', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age', 'orgStudyIdInfo': {'id': 'mRNA-1345-P301'}, 'secondaryIdInfos': [{'id': '2021-005026-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mRNA-1345', 'description': 'Single injection of mRNA-1345 on Day 1.', 'interventionNames': ['Drug: mRNA-1345']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Single injection of mRNA-1345 matching-placebo on Day 1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1345 BD', 'description': 'Single injection of mRNA-1345 on BD Day 1.', 'interventionNames': ['Drug: mRNA-1345']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '0.9% sodium chloride (normal saline) injection', 'armGroupLabels': ['Placebo']}, {'name': 'mRNA-1345', 'type': 'DRUG', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1345', 'mRNA-1345 BD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'AES - 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