Back to resultsSafety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older
Primary Purpose
Influenza Immunization
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Quadrivalent Influenza mRNA Vaccine MRT5413
Quadrivalent Recombinant Influenza Vaccine
Quadrivalent Influenza Standard Dose Vaccine
Quadrivalent Influenza High-Dose Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Immunization
Eligibility Criteria
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: 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: Participants are excluded from the study if any of the following criteria apply: Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Previous history of myocarditis, pericarditis, and / or myopericarditis Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Velocity Clinical Research-Chula Vista-Site Number:8400061
- Velocity Gardena-Site Number:8400062
- Long Beach Clinical Trials-Site Number:8400052
- Velocity Clinical Research, North Hollywood-Site Number:8400051
- California Research Foundation-Site Number:8400006
- Accel Clinical Research-Deland Clinical Research Unit-Site Number:8400032
- Velocity New Smyrna Beach-Site Number:8400063
- SIMEDHealth, LLC-Site Number:8400014
- Indago Research and Health Center-Site Number:8400044
- Research Centers of America-Site Number:8400011
- Florida International Research Center-Site Number:8400045
- Suncoast Research Associates, LLC-Site Number:8400060
- Florida Pulmonary Research Center-Site Number:8400036
- Meridian Clinical Research-Site Number:8400022
- Velocity Clinical Research-Site Number:8400024
- DM Clinical Research - Chicago-Site Number:8400025
- Brengle Family Medicine-Site Number:8400039
- Velocity Clinical Research Lincoln-Site Number:8400049
- Meridian Clinical Research-Site Number:8400017
- Meridian Clinical Research-Site Number:8400008
- Rochester Clinical Research. Inc.-Site Number:8400027
- Velocity Clinical Research-Site Number:8400001
- Velocity Clinical Research - Providence-Site Number:8400019
- Coastal Carolina Research Center-Site Number:8400042
- ClinSearch-Site Number:8400013
- Elligo Health Research, Inc.-Site Number:8400002
- Clinical Trials of Texas, Inc. - PPDS-Site Number:8400016
- DM Clinical Research - Sugar Land-Site Number:8400026
- Investigational Site Number :0360004
- Investigational Site Number :0360005
- Investigational Site Number :0360003
- Investigational Site Number :0360001
- Investigational Site Number :0360002
- Investigational Site Number :6300001
- Investigational Site Number :6300002
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose
Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose
Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose
Group 4: RIV4
Group 5: QIV-SD
Group 6: QIV-HD
Arm Description
participants will receive a single dose of QIV mRNA vaccine (low dose)
participants will receive a single dose of QIV mRNA vaccine (medium dose)
participants will receive a single dose of QIV mRNA vaccine (high dose)
participants will receive a single dose of RIV4 vaccine
participants will receive a single dose of QIV-SD vaccine
participants will receive a single dose of QIV -HD vaccine (for elderly only)
Outcomes
Primary Outcome Measures
Number of participants with immediate adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
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
Number of participants with unsolicited AEs
AEs that do not fulfill the conditions of solicited reactions
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
Number of participants with serious adverse events (SAEs)
SAEs reported throughout the study
Number of participants with out-of-range biological test results
Out-of-range biological test results (including shift from baseline values)
Individual Hemagglutination inhibition (HAI) titer
Antibody titers are expressed as GMTs at baseline and post-baseline
Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]
Individual HAI titer ratio
Ratios of antibody titers measured by HAI in each group before and after vaccination
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
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
Percentage of participants with 2-fold and 4-fold rise in HAI titers
Secondary Outcome Measures
Neutralizing Ab titers
Neutralizing Ab titers expressed as GMTs
Individual neutralizing antibodies titer ratio
Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
Individual HAI Ab titer ratio
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
Individual antibodies HAI titer ratio
Full Information
NCT ID
NCT05650554
First Posted
December 6, 2022
Last Updated
August 24, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT05650554
Brief Title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older
Official Title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adults Aged 18 Years and Older
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
March 13, 2024 (Anticipated)
Study Completion Date
March 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Study duration is approximately 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Immunization
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Sentinel Cohort: Open label
Main Cohort:
Open label (Sponsor, except laboratory testing personnel)
Blinded (Sites, except for those preparing/administering study intervention)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
684 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose
Arm Type
Experimental
Arm Description
participants will receive a single dose of QIV mRNA vaccine (low dose)
Arm Title
Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose
Arm Type
Experimental
Arm Description
participants will receive a single dose of QIV mRNA vaccine (medium dose)
Arm Title
Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose
Arm Type
Experimental
Arm Description
participants will receive a single dose of QIV mRNA vaccine (high dose)
Arm Title
Group 4: RIV4
Arm Type
Active Comparator
Arm Description
participants will receive a single dose of RIV4 vaccine
Arm Title
Group 5: QIV-SD
Arm Type
Active Comparator
Arm Description
participants will receive a single dose of QIV-SD vaccine
Arm Title
Group 6: QIV-HD
Arm Type
Active Comparator
Arm Description
participants will receive a single dose of QIV -HD vaccine (for elderly only)
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Influenza mRNA Vaccine MRT5413
Intervention Description
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Recombinant Influenza Vaccine
Other Intervention Name(s)
Flublok Quadrivalent®
Intervention Description
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Influenza Standard Dose Vaccine
Other Intervention Name(s)
Fluzone Qudrivalent®
Intervention Description
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe
Route of Administration: Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Influenza High-Dose Vaccine
Other Intervention Name(s)
Fluzone High-Dose Quadrivalent®
Intervention Description
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe
Route of Administration: Intramuscular injection
Primary Outcome Measure Information:
Title
Number of participants with immediate adverse events (AEs)
Description
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Time Frame
Within 30 minutes after injection
Title
Number of participants with solicited injection site or systemic reactions
Description
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
Time Frame
Up to 7 days after injection
Title
Number of participants with unsolicited AEs
Description
AEs that do not fulfill the conditions of solicited reactions
Time Frame
Up to 28 days after injection
Title
Number of participants with medically attended adverse events (MAAE)s
Description
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
Time Frame
Up to 180 days after injection
Title
Number of participants with serious adverse events (SAEs)
Description
SAEs reported throughout the study
Time Frame
From Day one to Day 366
Title
Number of participants with out-of-range biological test results
Description
Out-of-range biological test results (including shift from baseline values)
Time Frame
Up to 8 days after injection
Title
Individual Hemagglutination inhibition (HAI) titer
Description
Antibody titers are expressed as GMTs at baseline and post-baseline
Time Frame
At Day 1 and Day 29
Title
Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]
Time Frame
At Day 1 and Day 29
Title
Individual HAI titer ratio
Description
Ratios of antibody titers measured by HAI in each group before and after vaccination
Time Frame
At Day 1 and Day 29
Title
Number of participants archiving HAI seroconversion against Antigens
Description
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
Time Frame
At Day 1 and Day 29
Title
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
Time Frame
At Day 29
Title
Percentage of participants with 2-fold and 4-fold rise in HAI titers
Time Frame
At Day 1 and Day 29
Secondary Outcome Measure Information:
Title
Neutralizing Ab titers
Description
Neutralizing Ab titers expressed as GMTs
Time Frame
At Day 1 and Day 29
Title
Individual neutralizing antibodies titer ratio
Time Frame
At Day 1 and Day 29
Title
Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
Time Frame
At Day 1 and Day 29
Title
Individual HAI Ab titer ratio
Time Frame
Day 1, Day 91, Day 181 and Day 366
Title
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
Time Frame
At Day 91, Day 181 and Day 366
Title
Individual antibodies HAI titer ratio
Time Frame
Day 1, Day 91, Day 181 and Day 366
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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:
Participants are excluded from the study if any of the following criteria apply:
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Previous history of myocarditis, pericarditis, and / or myopericarditis
Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Velocity Clinical Research-Chula Vista-Site Number:8400061
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Velocity Gardena-Site Number:8400062
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Facility Name
Long Beach Clinical Trials-Site Number:8400052
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Velocity Clinical Research, North Hollywood-Site Number:8400051
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
California Research Foundation-Site Number:8400006
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
Country
United States
Facility Name
Accel Clinical Research-Deland Clinical Research Unit-Site Number:8400032
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720-0834
Country
United States
Facility Name
Velocity New Smyrna Beach-Site Number:8400063
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
SIMEDHealth, LLC-Site Number:8400014
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Indago Research and Health Center-Site Number:8400044
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Centers of America-Site Number:8400011
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Florida International Research Center-Site Number:8400045
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Suncoast Research Associates, LLC-Site Number:8400060
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Florida Pulmonary Research Center-Site Number:8400036
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Meridian Clinical Research-Site Number:8400022
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Velocity Clinical Research-Site Number:8400024
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
DM Clinical Research - Chicago-Site Number:8400025
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Brengle Family Medicine-Site Number:8400039
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Velocity Clinical Research Lincoln-Site Number:8400049
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Meridian Clinical Research-Site Number:8400017
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Meridian Clinical Research-Site Number:8400008
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Rochester Clinical Research. Inc.-Site Number:8400027
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Velocity Clinical Research-Site Number:8400001
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Velocity Clinical Research - Providence-Site Number:8400019
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Coastal Carolina Research Center-Site Number:8400042
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
ClinSearch-Site Number:8400013
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Elligo Health Research, Inc.-Site Number:8400002
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Clinical Trials of Texas, Inc. - PPDS-Site Number:8400016
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research - Sugar Land-Site Number:8400026
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Investigational Site Number :0360004
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Investigational Site Number :0360005
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Investigational Site Number :0360003
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Investigational Site Number :0360001
City
Morayfield
State/Province
Queensland
ZIP/Postal Code
4506
Country
Australia
Facility Name
Investigational Site Number :0360002
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Investigational Site Number :6300001
City
Barrio Sabana
ZIP/Postal Code
00694
Country
Puerto Rico
Facility Name
Investigational Site Number :6300002
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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
Learn more about this trial
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older
We'll reach out to this number within 24 hrs