Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06604767
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2024-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus 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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '-Investigators, Sponsor and study site staff, laboratory personnel, and participants will be blinded. Study staff preparing/administering the study interventions will be unblinded. Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohorts'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Modified double-blind study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination', 'timeFrame': 'Within 30 minutes after each vaccination', 'description': 'Number of participants experiencing immediate unsolicited systemic AEs'}, {'measure': 'Presence of solicited administration site reactions within 7 days after vaccination', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Number of participants reporting:\n\n\\- injection site reactions: pain, erythema and swelling'}, {'measure': 'Presence of solicited systemic reactions within 7 days after vaccination', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Number of participants reporting:\n\n* systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills'}, {'measure': 'Presence of unsolicited AEs within 28 days after vaccination', 'timeFrame': 'Within 28 days after vaccination', 'description': 'Number of participants experiencing unsolicited AEs'}, {'measure': 'Presence of serious adverse events (SAEs)', 'timeFrame': 'Within 6 months after vaccination', 'description': 'Number of participants experiencing SAEs regardless of causality'}, {'measure': 'Presence of adverse events of special interest (AESIs)', 'timeFrame': 'Within 6 months after vaccination', 'description': 'Number of participants experiencing AESIs regardless of causality'}, {'measure': 'Presence of related SAEs throughout the study', 'timeFrame': 'Throughout the study, approximately 12 months', 'description': 'Number of participants experiencing related SAEs regardless of causality'}, {'measure': 'Presence of related AESIs throughout the study', 'timeFrame': 'Throughout the study, approximately 12 months', 'description': 'Number of participants experiencing related AESIs regardless of causality'}, {'measure': 'Presence of related fatal SAEs throughout the study', 'timeFrame': 'Throughout the study, approximately 12 months', 'description': 'Number of participants experiencing related fatal SAEs regardless of causality'}, {'measure': 'Presence of out-of-range biological test results (including shift from baseline values)', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)'}], 'secondaryOutcomes': [{'measure': 'RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines', 'timeFrame': 'At Day 01 and Day 29', 'description': 'Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination'}, {'measure': 'RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines', 'timeFrame': 'At Day 01 and Day 29', 'description': 'Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination'}, {'measure': 'hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines', 'timeFrame': 'At Day 01 and Day 29', 'description': 'Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination'}, {'measure': 'PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines', 'timeFrame': 'At Day 01 and Day 29', 'description': 'Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus Infection', 'Metapneumovirus Infection', 'Parainfluenzae Virus Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.', 'detailedDescription': 'The study duration will be up to approximately 12 months minus the screening period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).\n* Informed consent form (ICF) has been signed and dated\n* A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.\n\nNote: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06604767', 'briefTitle': 'Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older', 'orgStudyIdInfo': {'id': 'VBD00006'}, 'secondaryIdInfos': [{'id': 'U1111-1304-9362', 'type': 'REGISTRY', 'domain': 'WHO ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIV3 Dose 1', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: parainfluenza virus type 3 vaccine (PIV3)']}, {'type': 'EXPERIMENTAL', 'label': 'PIV3 Dose 2', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: parainfluenza virus type 3 vaccine (PIV3)']}, {'type': 'EXPERIMENTAL', 'label': 'PIV3 Dose 3', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: parainfluenza virus type 3 vaccine (PIV3)']}, {'type': 'EXPERIMENTAL', 'label': 'PIV3 Dose 4', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: parainfluenza virus type 3 vaccine (PIV3)']}, {'type': 'EXPERIMENTAL', 'label': 'RSV/hMPV /PIV3 Formulation 1', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: RSV/hMPV/PIV3 vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'RSV/hMPV Formulation 1', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: RSV/hMPV vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'RSV/hMPV Formulation 2', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: RSV/hMPV vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'RSV vaccine 1', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: RSV vaccine 1']}, {'type': 'EXPERIMENTAL', 'label': 'RSV vaccine 2', 'description': 'Participants will receive a single intramuscular (IM) injection at Day 1', 'interventionNames': ['Biological: RSV vaccine 2']}], 'interventions': [{'name': 'parainfluenza virus type 3 vaccine (PIV3)', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular', 'armGroupLabels': ['PIV3 Dose 1', 'PIV3 Dose 2', 'PIV3 Dose 3', 'PIV3 Dose 4']}, {'name': 'RSV/hMPV/PIV3 vaccine', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular', 'armGroupLabels': ['RSV/hMPV /PIV3 Formulation 1']}, {'name': 'RSV/hMPV vaccine', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular', 'armGroupLabels': ['RSV/hMPV Formulation 1', 'RSV/hMPV Formulation 2']}, {'name': 'RSV vaccine 1', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular', 'armGroupLabels': ['RSV vaccine 1']}, {'name': 'RSV vaccine 2', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular', 'armGroupLabels': ['RSV vaccine 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360006', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '2019', 'city': 'Botany', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360001', 'geoPoint': {'lat': -33.94599, 'lon': 151.19591}}, {'zip': '2100', 'city': 'Brookvale', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360009', 'geoPoint': {'lat': -33.76108, 'lon': 151.27446}}, {'zip': '2259', 'city': 'Kanwal', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360005', 'geoPoint': {'lat': -33.253, 'lon': 151.4911}}, {'zip': '2228', 'city': 'Miranda', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360004', 'geoPoint': {'lat': -34.03857, 'lon': 151.10005}}, {'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360008', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3153', 'city': 'Bayswater', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360003', 'geoPoint': {'lat': -37.85, 'lon': 145.26667}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360002', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}]}, 'ipdSharingStatementModule': {'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 Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}