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Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (IGNITE P303)

Primary Purpose

Seasonal Influenza

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
mRNA-1010
Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Influenza focused on measuring mRNA-1010, Virus Diseases, Flu, Influenza vaccine, Moderna, mRNA vaccine

Eligibility Criteria

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

Inclusion Criteria: Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures. For assigned females at birth and of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration. Exclusion Criteria: Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1. Participant is acutely ill or febrile (temperature ≥38.0℃elcius [100.4°Fahrenheit]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window. Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections. Participant has tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein. Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal and topical steroids are allowed. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing. Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing. Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1. Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1. Participant is not aware whether they have received an influenza vaccine in the prior 12 months. Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study. Note: Other inclusion and exclusion criteria may apply.

Sites / Locations

  • Pinnacle Research Group
  • North Alabama Research Center LLC
  • Cullman Research Center
  • Desert Clinical Research - CCT
  • Foothills Research Center - CCT
  • Fiel Family & Sports Medicine - PC - CCT
  • Baptist Health Center for Clinical Research
  • Synexus Clinical Research US, Inc. - Cerritos
  • Artemis Institute For Clinical Research LLC - Riverside - Headlands
  • Peninsula Research Associates - CRN
  • Acclaim Clinical Research
  • Chase Medical Research LLC - Waterbury
  • Accel Research Site - Deland Clinical Research - ERN
  • Velocity Clinical Research - Hallandale Beach
  • Indago Research and Health Center
  • Health Awareness - Jupiter - ERN
  • Accel Research Sites - St. Petersburg - ERN
  • Flourish Research - Miami
  • Innovation Medical Research Center - ClinEdge
  • Synexus Clinical Research US, Inc. - Atlanta
  • Atlanta Cardiology and Primary Care
  • Accel Research Site - NeuroStudies.net, LLC - ERN
  • Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara
  • Clinical Research Atlanta - ERN
  • Flourish Research - Ravenswood
  • Synexus Clinical Research US, Inc. - Chicago
  • DM Clinical Research - Chicago - ERN
  • Meridian Clinical Research (Overland Park - Kansas)
  • Meridian Clinical Research (Baton Rouge - Louisiana)
  • Javara Research Inc. - Annapolis - Javara
  • Clinical Research Institute, Inc - CRN
  • Methodist Physicians Clinic - CCT Research
  • Meridian Clinical Research (Omaha - Nebraska)
  • Midwest Regional Health Services - LLC - CCT
  • Meridian Clinical Research (Endwell - New York)
  • Tryon Medical Practice - South Park - Javara
  • Lucas Research - Morehead City - HyperCore
  • CTI Clinical Research Center
  • Meridian Clinical Research - (Cincinnati - Ohio)
  • Velocity Clinical Research - Grants Pass
  • DM Clinical Research - Philadelphia - ERN
  • Velocity Clinical Research - Columbia
  • Velocity Clinical Research - Gaffney
  • DM Clinical Research - Texas Center for Drug Development - Humble - ERN
  • Epic Clinical Research
  • Clinical Trials of Texas, Inc.
  • DM Clinical Research - Sugarland - ERN
  • Privia Medical Group Physicians' Group of The Woodlands - Javara
  • Cope Family Medicine - CCT
  • Olympus Family Medicine - CCT
  • J. Lewis Research, Inc., Foothill Family Clinic
  • South Ogden Family Medicine - CCT
  • Clinical Research Partners LLC - Richmond - ERN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mRNA-1010

Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

Arm Description

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.

Outcomes

Primary Outcome Measures

Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
Percentage of Participants Reaching Seroconversion as Measured by HAI Assay
Seroconversion is defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer.
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with Medically-Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation from Study Participation

Secondary Outcome Measures

Percentage of Participants with HAI Titer of ≥1:40 at Day 29
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29

Full Information

First Posted
April 13, 2023
Last Updated
September 28, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05827978
Brief Title
Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
Acronym
IGNITE P303
Official Title
A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

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 primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against vaccine-matched influenza A and B strains at Day 29 and to evaluate the safety and reactogenicity of mRNA-1010.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza
Keywords
mRNA-1010, Virus Diseases, Flu, Influenza vaccine, Moderna, mRNA vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1010
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Arm Title
Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Arm Type
Active Comparator
Arm Description
Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
mRNA-1010
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Other Intervention Name(s)
Fluarix Quadrivalent
Intervention Description
Sterile suspension for injection
Primary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
Time Frame
Day 29
Title
Percentage of Participants Reaching Seroconversion as Measured by HAI Assay
Description
Seroconversion is defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer.
Time Frame
Day 29
Title
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
Up to Day 7 (7 days after vaccination)
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 28 (28 days after vaccination)
Title
Number of Participants with Medically-Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation from Study Participation
Time Frame
Day 1 through Day 181
Secondary Outcome Measure Information:
Title
Percentage of Participants with HAI Titer of ≥1:40 at Day 29
Time Frame
Day 29
Title
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
Time Frame
Baseline (Day 1), Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures. For assigned females at birth and of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration. Exclusion Criteria: Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1. Participant is acutely ill or febrile (temperature ≥38.0℃elcius [100.4°Fahrenheit]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window. Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections. Participant has tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein. Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal and topical steroids are allowed. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing. Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing. Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1. Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1. Participant is not aware whether they have received an influenza vaccine in the prior 12 months. Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study. Note: Other inclusion and exclusion criteria may apply.
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
North Alabama Research Center LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Cullman Research Center
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Desert Clinical Research - CCT
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Foothills Research Center - CCT
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Fiel Family & Sports Medicine - PC - CCT
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Cerritos
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Artemis Institute For Clinical Research LLC - Riverside - Headlands
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Peninsula Research Associates - CRN
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Acclaim Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Chase Medical Research LLC - Waterbury
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Accel Research Site - Deland Clinical Research - ERN
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Velocity Clinical Research - Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Health Awareness - Jupiter - ERN
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Accel Research Sites - St. Petersburg - ERN
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Flourish Research - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Innovation Medical Research Center - ClinEdge
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Cardiology and Primary Care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Accel Research Site - NeuroStudies.net, LLC - ERN
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Clinical Research Atlanta - ERN
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Flourish Research - Ravenswood
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
DM Clinical Research - Chicago - ERN
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Meridian Clinical Research (Overland Park - Kansas)
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Meridian Clinical Research (Baton Rouge - Louisiana)
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Javara Research Inc. - Annapolis - Javara
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Clinical Research Institute, Inc - CRN
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Methodist Physicians Clinic - CCT Research
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Meridian Clinical Research (Omaha - Nebraska)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Midwest Regional Health Services - LLC - CCT
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Meridian Clinical Research (Endwell - New York)
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Tryon Medical Practice - South Park - Javara
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28287
Country
United States
Facility Name
Lucas Research - Morehead City - HyperCore
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Meridian Clinical Research - (Cincinnati - Ohio)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Velocity Clinical Research - Grants Pass
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
DM Clinical Research - Philadelphia - ERN
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Velocity Clinical Research - Columbia
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Velocity Clinical Research - Gaffney
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Facility Name
DM Clinical Research - Texas Center for Drug Development - Humble - ERN
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Epic Clinical Research
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research - Sugarland - ERN
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Privia Medical Group Physicians' Group of The Woodlands - Javara
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
Cope Family Medicine - CCT
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Olympus Family Medicine - CCT
City
Holladay
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
J. Lewis Research, Inc., Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
South Ogden Family Medicine - CCT
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Clinical Research Partners LLC - Richmond - ERN
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

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