Clinical trial NCT05827978: Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Influenza
Keywords: mRNA-1010
Virus Diseases
Flu
Influenza vaccine
Moderna
mRNA vaccine
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-25
Enrollment: 8422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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.

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 (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.

Primary outcomes:
measure: Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
timeFrame: Day 29
measure: Percentage of Participants Reaching Seroconversion as Measured by HAI Assay
timeFrame: Day 29
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 7 (7 days after vaccination)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 28 (28 days after vaccination)
measure: Number of Participants with Medically-Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
timeFrame: Day 1 through Day 181
Secondary outcomes:
measure: Percentage of Participants with HAI Titer of ≥1:40 at Day 29
timeFrame: Day 29
measure: Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
timeFrame: Baseline (Day 1), Day 29
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Athens
country: United States
facility: North Alabama Research Center LLC
state: Alabama
city: Cullman
country: United States
facility: Cullman Research Center
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center Inc
state: Alabama
city: Mesa
country: United States
facility: Desert Clinical Research - CCT
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center - CCT
state: Arizona
city: Tempe
country: United States
facility: Fiel Family &amp; Sports Medicine - PC - CCT
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Banning
country: United States
facility: Velocity Clinical Research, Banning
state: California
city: Cerritos
country: United States
facility: Synexus Clinical Research US, Inc. - Cerritos
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research 002, LLC
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research
state: California
city: Pasadena
country: United States
facility: Pasadena Clinical Trials
state: California
city: Riverside
country: United States
facility: Artemis Institute For Clinical Research LLC - Riverside - Headlands
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates - CRN
state: California
city: San Diego
country: United States
facility: Optimal Research, LLC
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Waterbury
country: United States
facility: Chase Medical Research LLC - Waterbury
state: Connecticut
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Hialeah
country: United States
facility: NeoClinical Reseaarch
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness Inc
state: Florida
city: Lake City
country: United States
facility: Wr-Msra, Llc.
state: Florida
city: Lake Mary
country: United States
facility: Sandhill Research, LLC d/b/a Accel Research Sites Network
state: Florida
city: Lake Mary
country: United States
facility: Sandhill Research, LLC d/b/a Accel Research Sites
state: Florida
city: Lake Mary
country: United States
facility: University Clinical Research-DeLand, LLC d/b/a Accel Research
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Group, LLC.
state: Florida
city: Pembroke Pines
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Saint Augustine
country: United States
facility: St. Johns Center for Clinical Research - ERN
state: Florida
city: Tampa
country: United States
facility: New Tampa Health, Inc.
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc. - The Villages
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US, Inc. - Atlanta
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Fayetteville
country: United States
facility: Javara, Inc.
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah
state: Georgia
city: Stockbridge
country: United States
facility: CRA, Headlands LLC
state: Georgia
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc. - Chicago
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials- Ravenswood
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research
state: Illinois
city: Valparaiso
country: United States
facility: Velocity Clinical Research - Valparaiso
state: Indiana
city: Lenexa
country: United States
facility: Johnson County Clin-Trials (JCCT)
state: Kansas
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Overland Park
country: United States
facility: Velocity Clinical Research, Inc.
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Baton Rouge
country: United States
facility: Velocity Clinic Research, Inc.
state: Louisiana
city: Covington
country: United States
facility: Velocity Clinical Research, Covington
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Annapolis
country: United States
facility: Javara Inc.
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research, Rockville
state: Maryland
city: Troy
country: United States
facility: Oakland Medical Research
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc - CRN
state: Minnesota
city: Gulfport
country: United States
facility: DelRicht Research
state: Mississippi
city: Gulfport
country: United States
facility: Velocity Clinical Research, Gulfport
state: Mississippi
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC dba QPS-MO
state: Missouri
city: Fremont
country: United States
facility: Methodist Physicians Clinic - CCT Research
state: Nebraska
city: Grand Island
country: United States
facility: Velocity Clinical Research- Grand Island
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research (Norfolk - Nebraska) - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research (Omaha - Nebraska) - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Midwest Regional Health Services - LLC - CCT
state: Nebraska
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Nevada
city: Binghamton
country: United States
facility: Velocity Clinical Research (Binghamton - New York) - PPDS
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research, Inc.
state: New York
city: Charlotte
country: United States
facility: Javara Inc.
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research Inc.
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Mt. Auburn
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Inc.
state: Ohio
city: Tulsa
country: United States
facility: DelRicht Research
state: Oklahoma
city: Grants Pass
country: United States
facility: Velocity Clinical Research - Grants Pass
state: Oregon
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia - ERN
state: Pennsylvania
city: Columbia
country: United States
facility: Velocity Clinical Research - Columbia
state: South Carolina
city: Gaffney
country: United States
facility: Velocity Clinical Research - Gaffney
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Hendersonville
country: United States
facility: DelRicht Research
state: Tennessee
city: Austin
country: United States
facility: Tekton Research - Austin - PPDS
state: Texas
city: Beaumont
country: United States
facility: Tekton Research, LLC.
state: Texas
city: Conroe
country: United States
facility: Javara Inc.
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research - DeSoto
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Humble
country: United States
facility: DM Clinical Research
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Javara Inc.
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine - CCT
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc., Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Olympus Family Medicine - CCT Research
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine Ogden Clinic/CCT Research
state: Utah
city: Richmond
country: United States
facility: Clinical Research Partners LLC - Richmond - ERN
state: Virginia
Study officials:
References: