Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT06118151
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Open label (Sponsor) Blinded (Sites, except for those preparing/administering study intervention)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection', 'timeFrame': 'Within 30 minutes after injection', 'description': 'Number of participants with unsolicited systemic immediate adverse events (AEs)'}, {'measure': "Presence of solicited injection site reactions (ie, pre listed in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection", 'timeFrame': 'Up to 7 days after injection', 'description': 'Number of participants with solicited injection site reactions'}, {'measure': "Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection", 'timeFrame': 'Up to 7 days after injection', 'description': 'Number of participants with solicited systemic reactions'}, {'measure': 'Presence of unsolicited AEs reported up to 28 days after injection', 'timeFrame': 'Up to 28 days after injection', 'description': 'Number of participants with unsolicited AEs'}, {'measure': 'Presence of medically attended AEs (MAAEs) reported up to 28 days after injection', 'timeFrame': 'Up to 28 days after injection', 'description': 'Number of participants with medically attended adverse events (MAAE)s'}, {'measure': 'Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study', 'timeFrame': 'From baseline up to 6 months', 'description': 'Number of participants with serious adverse events (SAEs)'}, {'measure': 'Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection', 'timeFrame': 'Up to 28 days after injection', 'description': 'Number of participants with out-of-range biological test results'}], 'secondaryOutcomes': [{'measure': 'Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181', 'timeFrame': 'At Day 29, Day 91, and Day 181', 'description': 'Antibody titers are expressed as Geometric Mean Titers (GMTs)'}, {'measure': 'Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29', 'timeFrame': 'From baseline up to 6 months', 'description': 'Ratios of antibody titers measured by HAI in each group before and after vaccination'}, {'measure': 'HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181', 'timeFrame': 'At Day 29, Day 91 and Day 181'}, {'measure': '2-fold and 4-fold rise in HAI titers from D01 to D91 and D01 to D181', 'timeFrame': 'From Day 01 through Day 91 and Day 01 through Day 181'}, {'measure': 'Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181', 'timeFrame': 'At Day 29, Day 91, and Day 181'}, {'measure': 'Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29', 'timeFrame': 'From baseline up to 6 months'}, {'measure': '2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181', 'timeFrame': 'From Day 01 through Day 29 and Day 01 through Day 181'}, {'measure': 'HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181', 'timeFrame': 'At Day 01, Day 29, D91 and D181'}, {'measure': 'Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181', 'timeFrame': 'At Day 01, Day 29, Day 91, and Day 181'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza', 'Influenza Immunization']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include:\n\nStudy Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control.\n\nVisit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181', 'detailedDescription': 'Approximately 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:\n* Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06118151', 'briefTitle': 'Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older', 'orgStudyIdInfo': {'id': 'VAV00018'}, 'secondaryIdInfos': [{'id': 'U1111-1271-2001', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sentinel cohort 1', 'description': '20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control', 'interventionNames': ['Biological: Influenza Hemagglutinin mRNA vaccine', 'Biological: Quadrivalent Recombinant Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'sentinel cohort 2', 'description': '20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control', 'interventionNames': ['Biological: Influenza Hemagglutinin mRNA vaccine', 'Biological: Quadrivalent Recombinant Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'sentinel cohort 3', 'description': '10 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5 with half of the participants in each age group also receiving the RIV4 control', 'interventionNames': ['Biological: Influenza Hemagglutinin mRNA vaccine', 'Biological: Quadrivalent Recombinant Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'main cohort 1', 'description': '40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control', 'interventionNames': ['Biological: Influenza Hemagglutinin mRNA vaccine', 'Biological: Quadrivalent Recombinant Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'main cohort 2', 'description': '40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control', 'interventionNames': ['Biological: Influenza Hemagglutinin mRNA vaccine', 'Biological: Quadrivalent Recombinant Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'main cohort 3', 'description': '20 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5, and half number of the participants in each age group also receiving the RIV4 control', 'interventionNames': ['Biological: Influenza Hemagglutinin mRNA vaccine', 'Biological: Quadrivalent Recombinant Influenza Vaccine']}], 'interventions': [{'name': 'Influenza Hemagglutinin mRNA vaccine', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Solution for injection-Route of administration:IM injection', 'armGroupLabels': ['main cohort 1', 'main cohort 2', 'main cohort 3', 'sentinel cohort 1', 'sentinel cohort 2', 'sentinel cohort 3']}, {'name': 'Quadrivalent Recombinant Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['RIV4', 'Flublok Quadrivalent®'], 'description': 'Pharmaceutical form:Solution for injection-Route of administration:IM injection', 'armGroupLabels': ['main cohort 1', 'main cohort 2', 'main cohort 3', 'sentinel cohort 1', 'sentinel cohort 2', 'sentinel cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Peninsula Research Associates Site Number : 8400013', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Optimal Research Site Number : 8400026', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America Site Number : 8400003', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC Site Number : 8400016', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'AES Peoria Site Number : 8400017', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '67042', 'city': 'El Dorado', 'state': 'Kansas', 'country': 'United States', 'facility': 'AMR El Dorado Site Number : 8400009', 'geoPoint': {'lat': 37.81724, 'lon': -96.86225}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'AMR - Newton Site Number : 8400005', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'AMR Wichita West Site Number : 8400030', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'AMR Lexington Site Number : 8400014', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Benchmark Research Site Number : 8400010', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '68112', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Quality Clinical Research Site Number : 8400018', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Velocity Clinical Research, Omaha Site Number : 8400007', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Velocity Clinical Research Vestal Site Number : 8400033', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '29405', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center - N Charleston Site Number : 8400008', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'AMR Knoxville Site Number : 8400027', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78704', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Elligo Health Research, Inc. Site Number : 8400035', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research - Austin Site Number : 8400006', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'AES Austin Site Number : 8400021', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc. Site Number : 8400012', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, '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'}}}}