Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT07071558
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Investigators, study site staff, laboratory personnel, outcome assessors, and participants will be blinded throughout the study. Study staff preparing and administering the study interventions will be unblinded throughout the study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of any unsolicited systemic adverse events (aes)', 'timeFrame': 'Within 30 minutes after each vaccine injection', 'description': 'Number of participants experiencing immediate AEs'}, {'measure': "Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)", 'timeFrame': 'Through 7 days after each vaccine injection', 'description': 'Number of participants experiencing solicited injection site reactions'}, {'measure': 'Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)', 'timeFrame': 'Through 7 days after each vaccine injection', 'description': 'Number of participants experiencing solicited systemic reactions'}, {'measure': 'Presence of unsolicited AEs', 'timeFrame': 'Day 1 through day 29', 'description': 'Number of participants experiencing unsolicited AEs'}, {'measure': 'Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)', 'timeFrame': 'Throughout study, approximately 6 months', 'description': 'Number of participants experiencing SAEs and AESIs'}, {'measure': 'Presence of out-of-range biological test results (including shift from baseline values)', 'timeFrame': 'Through 7 days after each vaccine injection', 'description': 'number of participants with out-of-range biological tests'}, {'measure': 'RSV A nAb (Neutralizing Antibodies) titers', 'timeFrame': 'At day 1 and day 29'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RSV', 'RSV Infection', 'RSV Vaccine'], 'conditions': ['Respiratory Syncytial Virus Immunization']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sanofi.trialsummaries.com/Study/StudyDetails?id=26837&tenant=MT_SNY_9011', 'label': 'Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age.\n\n-Each participant will remain in the study for approximately 6 months.\n\n* The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01).\n* The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 to 49 years on the day of inclusion\n* A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:\n\n * Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR\n * Is of CBP (Child-Bearing Potential) and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.\n\nExclusion Criteria:\n\n* Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives\n* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT07071558', 'briefTitle': 'Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different LNP Formulations of mRNA Vaccines Using the RSV Monovalent Antigen in Healthy Participants 18 to 49 Years of Age', 'orgStudyIdInfo': {'id': 'VAV00026'}, 'secondaryIdInfos': [{'id': 'WHO UTN', 'type': 'OTHER', 'domain': 'U1111-1321-1812'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RSV Formulation 1', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV vaccine formulation 1 dose']}, {'type': 'EXPERIMENTAL', 'label': 'RSV Formulation 2', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV vaccine formulation 2 dose']}, {'type': 'EXPERIMENTAL', 'label': 'RSV Formulation 3', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV vaccine formulation 3 dose']}, {'type': 'EXPERIMENTAL', 'label': 'RSV Formulation 4', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV vaccine formulation 4 dose']}, {'type': 'EXPERIMENTAL', 'label': 'RSV Formulation 5', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV vaccine formulation 5 dose']}, {'type': 'EXPERIMENTAL', 'label': 'RSV Formulation 6', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV vaccine formulation 6 dose']}, {'type': 'EXPERIMENTAL', 'label': 'Control group 1 dose 1', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV vaccine formulation 7 dose']}, {'type': 'EXPERIMENTAL', 'label': 'Control group 2 dose 2', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV vaccine formulation 8 dose']}], 'interventions': [{'name': 'RSV vaccine formulation 1 dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection. Route of administration: IM injection', 'armGroupLabels': ['RSV Formulation 1']}, {'name': 'RSV vaccine formulation 2 dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection. Route of administration: IM injection', 'armGroupLabels': ['RSV Formulation 2']}, {'name': 'RSV vaccine formulation 3 dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection. Route of administration: IM injection', 'armGroupLabels': ['RSV Formulation 3']}, {'name': 'RSV vaccine formulation 4 dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection. Route of administration: IM injection', 'armGroupLabels': ['RSV Formulation 4']}, {'name': 'RSV vaccine formulation 5 dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection. Route of administration: IM injection', 'armGroupLabels': ['RSV Formulation 5']}, {'name': 'RSV vaccine formulation 6 dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection. Route of administration: IM injection', 'armGroupLabels': ['RSV Formulation 6']}, {'name': 'RSV vaccine formulation 7 dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection. Route of administration: IM injection', 'armGroupLabels': ['Control group 1 dose 1']}, {'name': 'RSV vaccine formulation 8 dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection. Route of administration: IM injection', 'armGroupLabels': ['Control group 2 dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Site # 0361003', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '4006', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Site # 0361006', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4506', 'city': 'Morayfield', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Site # 0361005', 'geoPoint': {'lat': -27.10876, 'lon': 152.94907}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Site # 0361004', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '3153', 'city': 'Bayswater', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Site # 0361002', 'geoPoint': {'lat': -37.85, 'lon': 145.26667}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Site # 0361001', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}