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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1279-3180 | 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 messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-dose (SD), QIV high-dose (HD) [adults ≥ 65 years of age only], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.
Study duration is approximately 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose | Experimental | participants will receive a single dose of QIV mRNA vaccine (low dose) |
|
| Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose | Experimental | participants will receive a single dose of QIV mRNA vaccine (medium dose) |
|
| Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose | Experimental | participants will receive a single dose of QIV mRNA vaccine (high dose) |
|
| 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 MRT5413 | Biological | Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
| 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 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 | Up to 7 days after injection |
| Number of participants with unsolicited AEs | AEs that do not fulfill the conditions of solicited reactions | Up to 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 | Up to 180 days after injection |
| Number of participants with serious adverse events (SAEs) | SAEs reported throughout the study | From Day one to Day 366 |
| Number of participants with out-of-range biological test results | Out-of-range biological test results (including shift from baseline values) | Up to 8 days after injection |
| Individual Hemagglutination inhibition (HAI) titer |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing Ab titers | Neutralizing Ab titers expressed as GMTs | At Day 1 and Day 29 |
| Individual neutralizing antibodies titer ratio | At Day 1 and Day 29 |
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Inclusion Criteria:
Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)
A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research-Chula Vista Site Number : 8400061 | Chula Vista | California | 91911 | 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 (for elderly only) |
|
| Quadrivalent Recombinant Influenza Vaccine | Biological | Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
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| Quadrivalent Influenza Standard Dose Vaccine | Biological | Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection |
|
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| Quadrivalent Influenza High-Dose Vaccine | Biological | Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection |
|
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Antibody titers are expressed as GMTs at baseline and post-baseline
| At Day 1 and Day 29 |
| Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil] | At Day 1 and Day 29 |
| Individual HAI titer ratio | Ratios of antibody titers measured by HAI in each group before and after vaccination | At 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 | At Day 1 and Day 29 |
| Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil] | At Day 29 |
| Percentage of participants with 2-fold and 4-fold rise in HAI titers | At Day 1 and Day 29 |
| Percentage of participants with 2-fold and 4-fold increase in neutralizing titers | At 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] | At Day 91, Day 181 and Day 366 |
| Individual antibodies HAI titer ratio | Day 1, Day 91, Day 181 and Day 366 |
| Velocity Gardena Site Number : 8400062 |
| Gardena |
| California |
| 90247 |
| United States |
| Long Beach Clinical Trials Site Number : 8400052 | Long Beach | California | 90806 | United States |
| Velocity Clinical Research, North Hollywood Site Number : 8400051 | North Hollywood | California | 91606 | United States |
| California Research Foundation Site Number : 8400006 | San Diego | California | 92123-1881 | United States |
| Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400032 | DeLand | Florida | 32720-0834 | United States |
| Velocity New Smyrna Beach Site Number : 8400063 | Edgewater | Florida | 32132 | United States |
| SIMEDHealth, LLC Site Number : 8400014 | Gainesville | Florida | 32607 | United States |
| Indago Research and Health Center Site Number : 8400044 | Hialeah | Florida | 33012 | United States |
| Cenexel Research Centers of America Site Number : 8400011 | Hollywood | Florida | 33024 | United States |
| Florida International Research Center Site Number : 8400045 | Miami | Florida | 33173 | United States |
| Suncoast Research Associates, LLC Site Number : 8400060 | Miami | Florida | 33173 | United States |
| Florida Pulmonary Research Center Site Number : 8400036 | Winter Park | Florida | 32789 | United States |
| Meridian Clinical Research Site Number : 8400022 | Savannah | Georgia | 31406 | United States |
| Velocity Clinical Research Site Number : 8400024 | Meridian | Idaho | 83642 | United States |
| DM Clinical Research - Chicago Site Number : 8400025 | River Forest | Illinois | 60305 | United States |
| Brengle Family Medicine Site Number : 8400039 | Indianapolis | Indiana | 46260 | United States |
| Velocity Clinical Research Lincoln Site Number : 8400049 | Lincoln | Nebraska | 68510 | United States |
| Meridian Clinical Research Site Number : 8400017 | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research Site Number : 8400008 | Omaha | Nebraska | 68134 | United States |
| Rochester Clinical Research. Inc. Site Number : 8400027 | Rochester | New York | 14609 | United States |
| Velocity Clinical Research Site Number : 8400001 | Cleveland | Ohio | 44122 | United States |
| Velocity Clinical Research - Providence Site Number : 8400019 | East Greenwich | Rhode Island | 02818 | United States |
| Coastal Carolina Research Center Site Number : 8400042 | North Charleston | South Carolina | 29405 | United States |
| ClinSearch Site Number : 8400013 | Chattanooga | Tennessee | 37421 | United States |
| Elligo Health Research, Inc. Site Number : 8400002 | Austin | Texas | 78704 | United States |
| DM Clinical Research- Bellaire Site Number : 8400026 | Houston | Texas | 77081 | United States |
| Clinical Trials of Texas, Inc. - PPDS Site Number : 8400016 | San Antonio | Texas | 78229 | United States |
| Investigational Site Number : 0360004 | Darlinghurst | New South Wales | 2010 | Australia |
| Investigational Site Number : 0360005 | Kanwal | New South Wales | 2259 | Australia |
| Investigational Site Number : 0360003 | Maroubra | New South Wales | 2035 | Australia |
| Investigational Site Number : 0360001 | Morayfield | Queensland | 4506 | Australia |
| Investigational Site Number : 0360002 | North Melbourne | Victoria | 3051 | Australia |
| Investigational Site Number : 6300001 | Barrio Sabana | 00694 | Puerto Rico |
| Investigational Site Number : 6300002 | 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 |
|---|---|
| D014612 | Vaccines |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014765 | Viral Vaccines |
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