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Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older

Primary Purpose

Influenza Immunization

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Quadrivalent Influenza mRNA Vaccine MRT5410
Quadrivalent Recombinant Influenza vaccine RIV4
Quadrivalent Inactivated Influenza Standard Dose QIV-SD
Quadrivalent Inactivated Influenza High Dose QIV-HD
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Immunization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: 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 IM vaccination based on Investigator's judgment Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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

  • Joint Clinical Trials Huntington Park-Site Number:8400032
  • Long Beach Clinical Trials-Site Number:8400056
  • Velocity Clinical Research, North Hollywood-Site Number:8400063
  • California Research Foundation-Site Number:8400001
  • SIMEDHealth, LLC-Site Number:8400042
  • Indago Research and Health Center-Site Number:8400002
  • Research Centers of America-Site Number:8400011
  • Florida International Research Center-Site Number:8400009
  • Palm Beach Research Center-Site Number:8400041
  • Velocity Clinical Research-Site Number:8400024
  • Brengle Family Medicine-Site Number:8400040
  • AMR Lexington-Site Number:8400035
  • Meridian Clinical Research-Site Number:8400017
  • Meridian Clinical Research-Site Number:8400034
  • WR-CRCN, LLC-Site Number:8400060
  • Coastal Carolina Research Center - N Charleston-Site Number:8400007
  • ClinSearch-Site Number:8400013
  • AMR Knoxville-Site Number:8400021
  • Elligo Health Research, Inc.-Site Number:8400037
  • Tekton Research, Inc-Site Number:8400051
  • Clinical Trials of Texas, Inc. - PPDS-Site Number:8400043
  • DM Clinical Research - Sugar Land-Site Number:8400045
  • DM Clinical Research-Site Number:8400046
  • Martin Diagnostic Clinic-Site Number:8400058
  • Investigational Site Number :6300002
  • Investigational Site Number :6300001

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 MRT5410 low dose

Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose

Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose

Group 4: RIV4

Group 5: QIV-SD

Group 6: QIV-HD

Arm Description

participants will receive a single dose (low) of QIV mRNA vaccine

participants will receive a single dose (medium) of QIV mRNA vaccine

participants will receive a single dose (high) of QIV mRNA vaccine

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

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 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
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

First Posted
November 14, 2022
Last Updated
May 17, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT05624606
Brief Title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older
Official Title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adults Aged 18 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
March 14, 2024 (Anticipated)
Study Completion Date
March 14, 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
Product Manufactured in and Exported from the U.S.
Yes
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 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.
Detailed Description
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
682 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low dose
Arm Type
Experimental
Arm Description
participants will receive a single dose (low) of QIV mRNA vaccine
Arm Title
Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose
Arm Type
Experimental
Arm Description
participants will receive a single dose (medium) of QIV mRNA vaccine
Arm Title
Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose
Arm Type
Experimental
Arm Description
participants will receive a single dose (high) of QIV mRNA vaccine
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
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Influenza mRNA Vaccine MRT5410
Intervention Description
Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Recombinant Influenza vaccine RIV4
Other Intervention Name(s)
Flublok Quadrivalent®
Intervention Description
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Inactivated Influenza Standard Dose QIV-SD
Other Intervention Name(s)
Fluzone Quadrivalent®
Intervention Description
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Inactivated Influenza High Dose QIV-HD
Other Intervention Name(s)
Fluzone High-Dose Quadrivalent®
Intervention Description
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
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 reactions 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
Within 7 days after injection
Title
Number of participants with unsolicited AEs
Description
AEs that do not fulfill the conditions of solicited reactions
Time Frame
Within 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
Within 180 days after injection
Title
Number of participants with serious adverse events (SAEs)
Description
SAEs reported throughout the study
Time Frame
From Day 1 until 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
Within 8 days after injection
Title
Individual Hemagglutination inhibition (HAI) titer
Description
Antibody titers are expressed as GMTs at baseline and post-baseline
Time Frame
Day 1 and Day 29
Title
Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]
Time Frame
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
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
Day 1 and Day 29
Title
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
Time Frame
Day 29
Title
Percentage of participants with 2-fold and 4-fold rise in HAI titers
Time Frame
Day 1 and Day 29
Secondary Outcome Measure Information:
Title
Neutralizing Ab titers
Description
Neutralizing Ab titers expressed as GMTs
Time Frame
Day 1 and Day 29
Title
Individual neutralizing antibodies titer ratio
Time Frame
Day 1 and Day 29
Title
Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
Time Frame
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
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: 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 IM vaccination based on Investigator's judgment Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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
Joint Clinical Trials Huntington Park-Site Number:8400032
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Long Beach Clinical Trials-Site Number:8400056
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Velocity Clinical Research, North Hollywood-Site Number:8400063
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
California Research Foundation-Site Number:8400001
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
Country
United States
Facility Name
SIMEDHealth, LLC-Site Number:8400042
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Indago Research and Health Center-Site Number:8400002
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:8400009
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Palm Beach Research Center-Site Number:8400041
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
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
Brengle Family Medicine-Site Number:8400040
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
AMR Lexington-Site Number:8400035
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
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:8400034
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
WR-CRCN, LLC-Site Number:8400060
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Coastal Carolina Research Center - N Charleston-Site Number:8400007
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
AMR Knoxville-Site Number:8400021
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37919
Country
United States
Facility Name
Elligo Health Research, Inc.-Site Number:8400037
City
Austin
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
Tekton Research, Inc-Site Number:8400051
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Clinical Trials of Texas, Inc. - PPDS-Site Number:8400043
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research - Sugar Land-Site Number:8400045
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
DM Clinical Research-Site Number:8400046
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Martin Diagnostic Clinic-Site Number:8400058
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Investigational Site Number :6300002
City
Barrio Sabana
ZIP/Postal Code
00694
Country
Puerto Rico
Facility Name
Investigational Site Number :6300001
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 MRT5410 in Adult Participants 18 Years of Age and Older

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