Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
- Conditions
- Seasonal Influenza
- Interventions
- Biological: Licensed Quadrivalent Inactivated Seasonal Influenza VaccineBiological: mRNA-1010
- Registration Number
- NCT05827978
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8422
- 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.
Part A:
- At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
Part B:
- At least 18 and <65 years of age, at the time of signing the ICF.
Part C:
- At least 65 years of age or older, at the time of signing the ICF.
- 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 (for Part A) or 180 days (for Parts B and C) 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) (for part A) or within 6 months (180 days) (for Parts B and C) 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 most recent influenza season (in the prior 12 months) (for Part A) or since September 2022 (for Parts B and C).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine 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. mRNA-1010 mRNA-1010 Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
- Primary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 Day 29 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.
Number of Participants with Medically-Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs), and AEs Leading to Discontinuation Day 1 through Day 181 Number of Participants with Unsolicited Adverse Events (AEs) Up to Day 28 (28 days after vaccination) Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to Day 7 (7 days after vaccination)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 Baseline (Day 1), Day 29 Percentage of Participants with HAI Titer of ≥1:40 at Day 29 Day 29
Trial Locations
- Locations (87)
Velocity Clinical Research, Rockville
🇺🇸Rockville, Maryland, United States
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Cullman Research Center
🇺🇸Cullman, Alabama, United States
Velocity Clinical Research, Banning
🇺🇸Banning, California, United States
North Alabama Research Center LLC
🇺🇸Athens, Alabama, United States
Velocity Clinical Research, Savannah
🇺🇸Savannah, Georgia, United States
Velocity Clinical Research
🇺🇸La Mesa, California, United States
Peninsula Research Associates - CRN
🇺🇸Rolling Hills Estates, California, United States
Lucas Research Inc.
🇺🇸Morehead City, North Carolina, United States
Epic Medical Research - DeSoto
🇺🇸DeSoto, Texas, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Medical Affiliated Research Center Inc
🇺🇸Huntsville, Alabama, United States
NeoClinical Reseaarch
🇺🇸Hialeah, Florida, United States
Tekton Research, LLC.
🇺🇸Beaumont, Texas, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Velocity Clinical Research - Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
South Ogden Family Medicine Ogden Clinic/CCT Research
🇺🇸South Ogden, Utah, United States
Velocity Clinical Research, Syracuse
🇺🇸East Syracuse, New York, United States
M3 Wake Research, Inc
🇺🇸Raleigh, North Carolina, United States
Suncoast Research Associates, LLC
🇺🇸Pembroke Pines, Florida, United States
Pasadena Clinical Trials
🇺🇸Pasadena, California, United States
Velocity Clinical Research (Binghamton - New York) - PPDS
🇺🇸Binghamton, New York, United States
Rochester Clinical Research, Inc
🇺🇸Rochester, New York, United States
University Clinical Research-DeLand, LLC d/b/a Accel Research
🇺🇸Lake Mary, Florida, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
Innovation Medical Group, LLC.
🇺🇸Palmetto Bay, Florida, United States
Cope Family Medicine - CCT
🇺🇸Bountiful, Utah, United States
Velocity Clinical Research - Grants Pass
🇺🇸Grants Pass, Oregon, United States
DM Clinical Research - Philadelphia - ERN
🇺🇸Philadelphia, Pennsylvania, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Synexus Clinical Research US, Inc. - Chicago
🇺🇸Chicago, Illinois, United States
South Florida Research Center, Inc
🇺🇸Miami, Florida, United States
Miami Clinical Research
🇺🇸Miami, Florida, United States
Alliance for Multispecialty Research, LLC
🇺🇸Las Vegas, Nevada, United States
Optimal Research, LLC
🇺🇸San Diego, California, United States
Acclaim Clinical Research
🇺🇸San Diego, California, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Clinical Research Institute, Inc - CRN
🇺🇸Minneapolis, Minnesota, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
J. Lewis Research, Inc., Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
Olympus Family Medicine - CCT Research
🇺🇸Salt Lake City, Utah, United States
Johnson County Clin-Trials (JCCT)
🇺🇸Lenexa, Kansas, United States
Fiel Family & Sports Medicine - PC - CCT
🇺🇸Tempe, Arizona, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Velocity Clinical Research- Grand Island
🇺🇸Grand Island, Nebraska, United States
Methodist Physicians Clinic - CCT Research
🇺🇸Fremont, Nebraska, United States
Desert Clinical Research - CCT
🇺🇸Mesa, Arizona, United States
Velocity Clinical Research, Covington
🇺🇸Covington, Louisiana, United States
Velocity Clinical Research, Gulfport
🇺🇸Gulfport, Mississippi, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
DelRicht Research
🇺🇸Hendersonville, Tennessee, United States
Chase Medical Research LLC - Waterbury
🇺🇸Waterbury, Connecticut, United States
Velocity Clinic Research, Inc.
🇺🇸Baton Rouge, Louisiana, United States
Velocity Clinical Research - Columbia
🇺🇸Columbia, South Carolina, United States
Velocity Clinical Research - Gaffney
🇺🇸Gaffney, South Carolina, United States
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
🇺🇸Norfolk, Nebraska, United States
Foothills Research Center - CCT
🇺🇸Phoenix, Arizona, United States
Velocity Clinical Research (Omaha - Nebraska) - PPDS
🇺🇸Omaha, Nebraska, United States
Midwest Regional Health Services - LLC - CCT
🇺🇸Omaha, Nebraska, United States
New Tampa Health, Inc.
🇺🇸Tampa, Florida, United States
Health Awareness Inc
🇺🇸Jupiter, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Sandhill Research, LLC d/b/a Accel Research Sites
🇺🇸Lake Mary, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Miami, Florida, United States
CenExel iResearch, LLC
🇺🇸Decatur, Georgia, United States
St. Johns Center for Clinical Research - ERN
🇺🇸Saint Augustine, Florida, United States
Synexus Clinical Research US, Inc. - The Villages
🇺🇸The Villages, Florida, United States
Great Lakes Clinical Trials- Ravenswood
🇺🇸Chicago, Illinois, United States
Velocity Clinical Research - Valparaiso
🇺🇸Valparaiso, Indiana, United States
Velocity Clinical Research, Inc.
🇺🇸Cincinnati, Ohio, United States
Javara Inc.
🇺🇸Sugar Land, Texas, United States
Synexus Clinical Research US, Inc. - Atlanta
🇺🇸Atlanta, Georgia, United States
Synexus Clinical Research US, Inc. - Cerritos
🇺🇸Cerritos, California, United States
Artemis Institute For Clinical Research LLC - Riverside - Headlands
🇺🇸Riverside, California, United States
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Marvel Clinical Research 002, LLC
🇺🇸Huntington Beach, California, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
Wr-Msra, Llc.
🇺🇸Lake City, Florida, United States
Sandhill Research, LLC d/b/a Accel Research Sites Network
🇺🇸Lake Mary, Florida, United States
Javara, Inc.
🇺🇸Fayetteville, Georgia, United States
CRA, Headlands LLC
🇺🇸Stockbridge, Georgia, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
🇺🇸Springfield, Missouri, United States
Epic Clinical Research
🇺🇸Lewisville, Texas, United States
Velocity Clinical Research, Mt. Auburn
🇺🇸Cincinnati, Ohio, United States
Clinical Research Partners LLC - Richmond - ERN
🇺🇸Richmond, Virginia, United States
Tekton Research - Austin - PPDS
🇺🇸Austin, Texas, United States