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

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05827978
Collaborator
(none)
2,400
Enrollment
61
Locations
2
Arms
8.8
Anticipated Duration (Months)
39.3
Patients Per Site
4.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: mRNA-1010
  • Biological: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 17, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jan 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: mRNA-1010

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

Biological: mRNA-1010
Sterile liquid for injection
Other Names:
  • Seasonal influenza vaccine

    		•
    Active Comparator: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

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

    Biological: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
    Sterile suspension for injection
    Other Names:
  • Fluarix Quadrivalent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 [Day 29]

    2. Percentage of Participants Reaching Seroconversion as Measured by HAI Assay [Day 29]

      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.

    3. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [Up to Day 7 (7 days after vaccination)]

    4. Number of Participants with Unsolicited Adverse Events (AEs) [Up to Day 28 (28 days after vaccination)]

    5. 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 [Day 1 through Day 181]

    Secondary Outcome Measures

    1. Percentage of Participants with HAI Titer of ≥1:40 at Day 29 [Day 29]

    2. Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 [Baseline (Day 1), Day 29]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pinnacle Research Group Anniston Alabama United States 36207
    2 North Alabama Research Center LLC Athens Alabama United States 35611
    3 Cullman Research Center Cullman Alabama United States 35058
    4 Desert Clinical Research - CCT Mesa Arizona United States 85213
    5 Foothills Research Center - CCT Phoenix Arizona United States 85044
    6 Fiel Family & Sports Medicine - PC - CCT Tempe Arizona United States 85283
    7 Baptist Health Center for Clinical Research Little Rock Arkansas United States 72205
    8 Synexus Clinical Research US, Inc. - Cerritos Cerritos California United States 90703
    9 Artemis Institute For Clinical Research LLC - Riverside - Headlands Riverside California United States 92503
    10 Peninsula Research Associates - CRN Rolling Hills Estates California United States 90274
    11 Optimal Research California - San Diego San Diego California United States 92108
    12 Acclaim Clinical Research San Diego California United States 92120
    13 St. Johns Center for Clinical Research - ERN Solana Beach California United States 92075
    14 Lynn Institute of Denver - ERN Denver Colorado United States 80246
    15 Stamford Therapeutics Consortium - ERN Stamford Connecticut United States 06905
    16 Chase Medical Research LLC - Waterbury Waterbury Connecticut United States 06708
    17 Accel Research Site - Deland Clinical Research - ERN DeLand Florida United States 32720
    18 Velocity Clinical Research - Hallandale Beach Hallandale Beach Florida United States 33009
    19 Indago Research and Health Center Hialeah Florida United States 33012
    20 Health Awareness - Jupiter - ERN Jupiter Florida United States 33458
    21 Multi-Specialty Research Associates, Inc. M3 WR Lake City Florida United States 32055
    22 Accel Research Sites - St. Petersburg - ERN Largo Florida United States 33777
    23 Flourish Research - Miami Miami Florida United States 33186
    24 Innovation Medical Research Center - ClinEdge Palmetto Bay Florida United States 33157
    25 Synexus Clinical Research US, Inc. - The Villages The Villages Florida United States 32162
    26 Synexus Clinical Research US, Inc. - Atlanta Atlanta Georgia United States 30328
    27 Atlanta Cardiology and Primary Care Atlanta Georgia United States 30342
    28 Accel Research Site - NeuroStudies.net, LLC - ERN Decatur Georgia United States 30030
    29 CenExel iResearch, LLC Decatur Georgia United States 30030
    30 Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara Fayetteville Georgia United States 30214
    31 Clinical Research Atlanta - ERN Stockbridge Georgia United States 30281
    32 Flourish Research - Ravenswood Chicago Illinois United States 60640
    33 Synexus Clinical Research US, Inc. - Chicago Chicago Illinois United States 60654
    34 DM Clinical Research - Chicago - ERN River Forest Illinois United States 60305
    35 Meridian Clinical Research (Overland Park - Kansas) Overland Park Kansas United States 66210
    36 Meridian Clinical Research (Baton Rouge - Louisiana) Baton Rouge Louisiana United States 70809
    37 Javara Research Inc. - Annapolis - Javara Annapolis Maryland United States 21401
    38 Clinical Research Institute, Inc - CRN Plymouth Minnesota United States 55441
    39 Methodist Physicians Clinic - CCT Research Fremont Nebraska United States 68025
    40 Meridian Clinical Research (Omaha - Nebraska) Omaha Nebraska United States 68134
    41 Midwest Regional Health Services - LLC - CCT Omaha Nebraska United States 68144
    42 Meridian Clinical Research (Endwell - New York) Endwell New York United States 13760
    43 Tryon Medical Practice - South Park - Javara Charlotte North Carolina United States 28287
    44 Lucas Research - Morehead City - HyperCore Morehead City North Carolina United States 28557
    45 M3 Wake Research, Inc - M3 WR Raleigh North Carolina United States 27612
    46 CTI Clinical Research Center Cincinnati Ohio United States 45227
    47 Meridian Clinical Research - (Cincinnati - Ohio) Cincinnati Ohio United States 45246
    48 Velocity Clinical Research - Grants Pass Ashland Oregon United States 97520
    49 DM Clinical Research - Philadelphia - ERN Philadelphia Pennsylvania United States 19107
    50 Velocity Clinical Research - Columbia Columbia South Carolina United States 29204
    51 Velocity Clinical Research - Gaffney Gaffney South Carolina United States 29340
    52 DM Clinical Research - Texas Center for Drug Development - Humble - ERN Humble Texas United States 77338
    53 Epic Clinical Research Lewisville Texas United States 75057
    54 Clinical Trials of Texas, Inc. San Antonio Texas United States 78229
    55 DM Clinical Research - Sugarland - ERN Sugar Land Texas United States 77478
    56 Privia Medical Group Physicians' Group of The Woodlands - Javara The Woodlands Texas United States 77382
    57 Cope Family Medicine - CCT Bountiful Utah United States 84010
    58 Olympus Family Medicine - CCT Holladay Utah United States 84117
    59 J. Lewis Research, Inc., Foothill Family Clinic Salt Lake City Utah United States 84109
    60 South Ogden Family Medicine - CCT South Ogden Utah United States 84405
    61 Clinical Research Partners LLC - Richmond - ERN Richmond Virginia United States 23226

    Sponsors and Collaborators

    • ModernaTX, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ModernaTX, Inc.
    ClinicalTrials.gov Identifier:
    NCT05827978
    Other Study ID Numbers:
    • mRNA-1010-P303
    First Posted:
    Apr 25, 2023
    Last Update Posted:
    Apr 25, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ModernaTX, Inc.
    mRNA-1010
    Virus Diseases
    Flu
    Influenza vaccine
    Moderna
    mRNA vaccine
    Additional relevant MeSH terms:
    Influenza, Human
    Vaccines

    Study Results

    No Results Posted as of Apr 25, 2023