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History of Changes for Study: NCT05827978
Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (IGNITE P303)
Latest version (submitted April 30, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 13, 2023 None (earliest Version on record)
2 May 2, 2023 Recruitment Status, Study Status, Contacts/Locations, Eligibility and Conditions
3 May 15, 2023 Recruitment Status, Contacts/Locations, Study Status and Study Design
4 July 13, 2023 Study Status
5 September 28, 2023 Study Status
6 November 20, 2023 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Study Design, Eligibility and Study Description
7 December 20, 2023 Study Status and Contacts/Locations
8 February 9, 2024 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study Design
9 April 30, 2024 Contacts/Locations and Study Status
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Study NCT05827978
Submitted Date:  April 13, 2023 (v1)

Open or close this module Study Identification
Unique Protocol ID: mRNA-1010-P303
Brief Title: Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2023
Overall Status: Not yet recruiting
Study Start: April 17, 2023
Primary Completion: July 31, 2023 [Anticipated]
Study Completion: January 10, 2024 [Anticipated]
First Submitted: April 13, 2023
First Submitted that
Met QC Criteria:
April 13, 2023
First Posted: April 25, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:
April 13, 2023
Last Update Posted: April 25, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ModernaTX, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Seasonal Influenza Infection
Keywords: mRNA-1010
Virus Diseases
Flu
Influenza vaccine
Moderna
mRNA vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 2400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
[ Time Frame: Day 29 ]

2. Percentage of Participants Reaching Seroconversion as Measured by HAI Assay
[ Time Frame: 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)
[ Time Frame: Up to Day 7 (7 days after vaccination) ]

4. Number of Participants with Unsolicited Adverse Events (AEs)
[ Time Frame: 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
[ Time Frame: Day 1 through Day 181 ]

Secondary Outcome Measures:
1. Percentage of Participants with HAI Titer of ≥1:40 at Day 29
[ Time Frame: Day 29 ]

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

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.

Open or close this module Contacts/Locations
Central Contact Person: Moderna Clinical Trials Support Center
Telephone: 1-877-777-7187
Email: clinicaltrials@modernatx.com
Locations: United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
North Alabama Research Center LLC
Athens, Alabama, United States, 35611
Cullman Research Center
Cullman, Alabama, United States, 35058
United States, Arizona
Desert Clinical Research - CCT
Mesa, Arizona, United States, 85213
Foothills Research Center - CCT
Phoenix, Arizona, United States, 85044
Fiel Family & Sports Medicine - PC - CCT
Tempe, Arizona, United States, 85283
United States, Arkansas
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
Synexus Clinical Research US, Inc. - Cerritos
Cerritos, California, United States, 90703
Artemis Institute For Clinical Research LLC - Riverside - Headlands
Riverside, California, United States, 92503
Peninsula Research Associates - CRN
Rolling Hills Estates, California, United States, 90274
Optimal Research California - San Diego
San Diego, California, United States, 92108
Acclaim Clinical Research
San Diego, California, United States, 92120
St. Johns Center for Clinical Research - ERN
Solana Beach, California, United States, 92075
United States, Colorado
Lynn Institute of Denver - ERN
Denver, Colorado, United States, 80246
United States, Connecticut
Stamford Therapeutics Consortium - ERN
Stamford, Connecticut, United States, 06905
Chase Medical Research LLC - Waterbury
Waterbury, Connecticut, United States, 06708
United States, Florida
Accel Research Site - Deland Clinical Research - ERN
DeLand, Florida, United States, 32720
Velocity Clinical Research - Hallandale Beach
Hallandale Beach, Florida, United States, 33009
Indago Research and Health Center
Hialeah, Florida, United States, 33012
Health Awareness - Jupiter - ERN
Jupiter, Florida, United States, 33458
Multi-Specialty Research Associates, Inc. M3 WR
Lake City, Florida, United States, 32055
Accel Research Sites - St. Petersburg - ERN
Largo, Florida, United States, 33777
Flourish Research - Miami
Miami, Florida, United States, 33186
Innovation Medical Research Center - ClinEdge
Palmetto Bay, Florida, United States, 33157
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, United States, 32162
United States, Georgia
Synexus Clinical Research US, Inc. - Atlanta
Atlanta, Georgia, United States, 30328
Atlanta Cardiology and Primary Care
Atlanta, Georgia, United States, 30342
Accel Research Site - NeuroStudies.net, LLC - ERN
Decatur, Georgia, United States, 30030
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara
Fayetteville, Georgia, United States, 30214
Clinical Research Atlanta - ERN
Stockbridge, Georgia, United States, 30281
United States, Illinois
Flourish Research - Ravenswood
Chicago, Illinois, United States, 60640
Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, United States, 60654
DM Clinical Research - Chicago - ERN
River Forest, Illinois, United States, 60305
United States, Kansas
Meridian Clinical Research (Overland Park - Kansas)
Overland Park, Kansas, United States, 66210
United States, Louisiana
Meridian Clinical Research (Baton Rouge - Louisiana)
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Javara Research Inc. - Annapolis - Javara
Annapolis, Maryland, United States, 21401
United States, Minnesota
Clinical Research Institute, Inc - CRN
Plymouth, Minnesota, United States, 55441
United States, Nebraska
Methodist Physicians Clinic - CCT Research
Fremont, Nebraska, United States, 68025
Meridian Clinical Research (Omaha - Nebraska)
Omaha, Nebraska, United States, 68134
Midwest Regional Health Services - LLC - CCT
Omaha, Nebraska, United States, 68144
United States, New York
Meridian Clinical Research (Endwell - New York)
Endwell, New York, United States, 13760
United States, North Carolina
Tryon Medical Practice - South Park - Javara
Charlotte, North Carolina, United States, 28287
Lucas Research - Morehead City - HyperCore
Morehead City, North Carolina, United States, 28557
M3 Wake Research, Inc - M3 WR
Raleigh, North Carolina, United States, 27612
United States, Ohio
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45227
Meridian Clinical Research - (Cincinnati - Ohio)
Cincinnati, Ohio, United States, 45246
United States, Oregon
Velocity Clinical Research - Grants Pass
Ashland, Oregon, United States, 97520
United States, Pennsylvania
DM Clinical Research - Philadelphia - ERN
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Velocity Clinical Research - Columbia
Columbia, South Carolina, United States, 29204
Velocity Clinical Research - Gaffney
Gaffney, South Carolina, United States, 29340
United States, Texas
DM Clinical Research - Texas Center for Drug Development - Humble - ERN
Humble, Texas, United States, 77338
Epic Clinical Research
Lewisville, Texas, United States, 75057
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
DM Clinical Research - Sugarland - ERN
Sugar Land, Texas, United States, 77478
Privia Medical Group Physicians' Group of The Woodlands - Javara
The Woodlands, Texas, United States, 77382
United States, Utah
Cope Family Medicine - CCT
Bountiful, Utah, United States, 84010
Olympus Family Medicine - CCT
Holladay, Utah, United States, 84117
J. Lewis Research, Inc., Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
South Ogden Family Medicine - CCT
South Ogden, Utah, United States, 84405
United States, Virginia
Clinical Research Partners LLC - Richmond - ERN
Richmond, Virginia, United States, 23226
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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