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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1275-1516 | Registry Identifier | ICTRP |
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The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD [adults ≥ 65 years of age only], or RIV4) in adults 18 years of age and older.
Approximately 12 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low dose | Experimental | participants will receive a single dose (low) of QIV mRNA vaccine |
|
| Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose | Experimental | participants will receive a single dose (medium) of QIV mRNA vaccine |
|
| Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose | Experimental | participants will receive a single dose (high) of QIV mRNA vaccine |
|
| Group 4: RIV4 | Active Comparator | participants will receive a single dose of RIV4 vaccine |
|
| Group 5: QIV-SD | Active Comparator | participants will receive a single dose of QIV-SD vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza mRNA Vaccine MRT5410 | Biological | Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with immediate adverse events (AEs) | Unsolicited systemic AEs that occur within 30 minutes after vaccination | Within 30 minutes after injection |
| Number of participants with solicited injection site reactions or systemic reactions | Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills | Within 7 days after injection |
| Number of participants with unsolicited AEs | AEs that do not fulfill the conditions of solicited reactions | Within 28 days after injection |
| Number of participants with medically attended adverse events (MAAE)s | AEs with a new onset or a worsening of a condition that prompts the participant or participant to seek unplanned medical advice at a physician's office or Emergency Department | Within 180 days after injection |
| Number of participants with serious adverse events (SAEs) | SAEs reported throughout the study | From Day 1 until Day 366 |
| Number of participants with out-of-range biological test results | Out-of-range biological test results (including shift from baseline values) | Within 8 days after injection |
| Individual Hemagglutination inhibition (HAI) titer |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing Ab titers | Neutralizing Ab titers expressed as GMTs | Day 1 and Day 29 |
| Individual neutralizing antibodies titer ratio | Day 1 and Day 29 |
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Inclusion Criteria:
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 OR Is of childbearing 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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Clinical Trials Huntington Park Site Number : 8400032 | Huntington Park | California | 90255 | United States | ||
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
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Sentinel Cohort: Open label
Main Cohort:
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This is a parallel-group prevention study with up to 6 arms that will be blinded to participants, investigators / sub-investigators, outcomes assessors, and laboratory personnel (with the exception of the sentinel safety portion of the study, which will be open-label). The Sponsor study staff will be unblinded (except laboratory testing personnel).
| Group 6: QIV-HD |
| Active Comparator |
participants will receive a single dose of QIV -HD vaccine |
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| Quadrivalent Recombinant Influenza vaccine RIV4 | Biological | Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular |
|
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| Quadrivalent Inactivated Influenza Standard Dose QIV-SD | Biological | Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular |
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| Quadrivalent Inactivated Influenza High Dose QIV-HD | Biological | Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular |
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Antibody titers are expressed as GMTs at baseline and post-baseline |
| Day 1 and Day 29 |
| Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil] | Day 1 and Day 29 |
| Individual HAI titer ratio | Ratios of antibody titers measured by HAI in each group before and after vaccination | Day 1 and Day 29 |
| Number of participants archiving HAI seroconversion against Antigens | Number of participants with titer < 10 [1/dil] at Day 1 and post-vaccination titer ≥ 40 [1/dil] at Day 29, or titer ≥ 10 [1/dil] at Day 1 and a ≥ 4-fold-rise in titer [1/dil] at Day 29 | Day 1 and Day 29 |
| Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil] | Day 29 |
| Percentage of participants with 2-fold and 4-fold rise in HAI titers | Day 1 and Day 29 |
| Percentage of participants with 2-fold and 4-fold increase in neutralizing titers | Day 1 and Day 29 |
| Individual HAI Ab titer ratio | Day 1, Day 91, Day 181 and Day 366 |
| Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil] | Day 91, Day 181 and Day 366 |
| Individual antibodies HAI titer ratio | Day 1, Day 91, Day 181 and Day 366 |
| Long Beach Clinical Trials Site Number : 8400056 |
| Long Beach |
| California |
| 90806 |
| United States |
| Velocity Clinical Research, North Hollywood Site Number : 8400063 | North Hollywood | California | 91606 | United States |
| California Research Foundation Site Number : 8400001 | San Diego | California | 92123-1881 | United States |
| SIMEDHealth, LLC Site Number : 8400042 | Gainesville | Florida | 32607 | United States |
| Indago Research and Health Center Site Number : 8400002 | Hialeah | Florida | 33012 | United States |
| Research Centers of America Site Number : 8400011 | Hollywood | Florida | 33024 | United States |
| Florida International Research Center Site Number : 8400009 | Miami | Florida | 33173 | United States |
| Palm Beach Research Center Site Number : 8400041 | West Palm Beach | Florida | 33409 | United States |
| Velocity Clinical Research Site Number : 8400024 | Meridian | Idaho | 83642 | United States |
| Brengle Family Medicine Site Number : 8400040 | Indianapolis | Indiana | 46260 | United States |
| AMR Lexington Site Number : 8400035 | Lexington | Kentucky | 40509 | United States |
| Meridian Clinical Research Site Number : 8400017 | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research Site Number : 8400034 | Omaha | Nebraska | 68134 | United States |
| WR-CRCN, LLC Site Number : 8400060 | Las Vegas | Nevada | 89106 | United States |
| Coastal Carolina Research Center - N Charleston Site Number : 8400007 | North Charleston | South Carolina | 29405 | United States |
| AMR Knoxville Site Number : 8400021 | Knoxville | Tennessee | 37919 | United States |
| Elligo Health Research, Inc. Site Number : 8400037 | Austin | Texas | 78704 | United States |
| Tekton Research, Inc Site Number : 8400051 | Austin | Texas | 78745 | United States |
| DM Clinical Research Site Number : 8400046 | Humble | Texas | 77338 | United States |
| Clinical Trials of Texas, Inc. - PPDS Site Number : 8400043 | San Antonio | Texas | 78229 | United States |
| DM Clinical Research - Sugar Land Site Number : 8400045 | Sugar Land | Texas | 77478 | United States |
| Martin Diagnostic Clinic Site Number : 8400058 | Tomball | Texas | 77375 | United States |
| Investigational Site Number : 6300002 | Barrio Sabana | 00694 | Puerto Rico |
| Investigational Site Number : 6300001 | San Juan | 00909 | Puerto Rico |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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