Seasonal Influenza Clinical Trial
— IGNITE P303Official 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
| Verified date | April 2024 |
| Source | ModernaTX, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 8400 |
| Est. completion date | June 24, 2024 |
| Est. primary completion date | June 24, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Javara Inc. | Annapolis | Maryland |
| United States | Pinnacle Research Group | Anniston | Alabama |
| United States | North Alabama Research Center LLC | Athens | Alabama |
| United States | Synexus Clinical Research US, Inc. - Atlanta | Atlanta | Georgia |
| United States | Tekton Research - Austin - PPDS | Austin | Texas |
| United States | Velocity Clinical Research, Banning | Banning | California |
| United States | Velocity Clinic Research, Inc. | Baton Rouge | Louisiana |
| United States | Tekton Research, LLC. | Beaumont | Texas |
| United States | Velocity Clinical Research (Binghamton - New York) - PPDS | Binghamton | New York |
| United States | Cope Family Medicine - CCT | Bountiful | Utah |
| United States | Synexus Clinical Research US, Inc. - Cerritos | Cerritos | California |
| United States | Javara Inc. | Charlotte | North Carolina |
| United States | Great Lakes Clinical Trials- Ravenswood | Chicago | Illinois |
| United States | Synexus Clinical Research US, Inc. - Chicago | Chicago | Illinois |
| United States | CTI Clinical Research Center | Cincinnati | Ohio |
| United States | Velocity Clinical Research, Inc. | Cincinnati | Ohio |
| United States | Velocity Clinical Research, Mt. Auburn | Cincinnati | Ohio |
| United States | Velocity Clinical Research - Columbia | Columbia | South Carolina |
| United States | Javara Inc. | Conroe | Texas |
| United States | Velocity Clinical Research, Covington | Covington | Louisiana |
| United States | Cullman Research Center | Cullman | Alabama |
| United States | CenExel iResearch, LLC | Decatur | Georgia |
| United States | Epic Medical Research - DeSoto | DeSoto | Texas |
| United States | Velocity Clinical Research, Syracuse | East Syracuse | New York |
| United States | Javara, Inc. | Fayetteville | Georgia |
| United States | Methodist Physicians Clinic - CCT Research | Fremont | Nebraska |
| United States | Velocity Clinical Research - Gaffney | Gaffney | South Carolina |
| United States | Velocity Clinical Research- Grand Island | Grand Island | Nebraska |
| United States | Velocity Clinical Research - Grants Pass | Grants Pass | Oregon |
| United States | DelRicht Research | Gulfport | Mississippi |
| United States | Velocity Clinical Research, Gulfport | Gulfport | Mississippi |
| United States | Velocity Clinical Research - Hallandale Beach | Hallandale Beach | Florida |
| United States | DelRicht Research | Hendersonville | Tennessee |
| United States | Indago Research and Health Center | Hialeah | Florida |
| United States | NeoClinical Reseaarch | Hialeah | Florida |
| United States | DM Clinical Research | Houston | Texas |
| United States | DM Clinical Research | Humble | Texas |
| United States | Marvel Clinical Research 002, LLC | Huntington Beach | California |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Health Awareness Inc | Jupiter | Florida |
| United States | Velocity Clinical Research | La Mesa | California |
| United States | Wr-Msra, Llc. | Lake City | Florida |
| United States | Sandhill Research, LLC d/b/a Accel Research Sites | Lake Mary | Florida |
| United States | Sandhill Research, LLC d/b/a Accel Research Sites Network | Lake Mary | Florida |
| United States | University Clinical Research-DeLand, LLC d/b/a Accel Research | Lake Mary | Florida |
| United States | Alliance for Multispecialty Research, LLC | Las Vegas | Nevada |
| United States | Johnson County Clin-Trials (JCCT) | Lenexa | Kansas |
| United States | Epic Clinical Research | Lewisville | Texas |
| United States | Baptist Health Center for Clinical Research | Little Rock | Arkansas |
| United States | Desert Clinical Research - CCT | Mesa | Arizona |
| United States | Clinical Site Partners, LLC dba Flourish Research | Miami | Florida |
| United States | Miami Clinical Research | Miami | Florida |
| United States | South Florida Research Center, Inc | Miami | Florida |
| United States | Suncoast Research Associates, LLC | Miami | Florida |
| United States | Floridian Clinical Research | Miami Lakes | Florida |
| United States | Clinical Research Institute, Inc - CRN | Minneapolis | Minnesota |
| United States | Lucas Research Inc. | Morehead City | North Carolina |
| United States | DelRicht Research | New Orleans | Louisiana |
| United States | Alliance for Multispecialty Research, LLC | Newton | Kansas |
| United States | Velocity Clinical Research (Norfolk - Nebraska) - PPDS | Norfolk | Nebraska |
| United States | Midwest Regional Health Services - LLC - CCT | Omaha | Nebraska |
| United States | Velocity Clinical Research (Omaha - Nebraska) - PPDS | Omaha | Nebraska |
| United States | Velocity Clinical Research, Inc. | Omaha | Nebraska |
| United States | Velocity Clinical Research, Inc. | Overland Park | Kansas |
| United States | Innovation Medical Group, LLC. | Palmetto Bay | Florida |
| United States | Pasadena Clinical Trials | Pasadena | California |
| United States | Suncoast Research Associates, LLC | Pembroke Pines | Florida |
| United States | DM Clinical Research - Philadelphia - ERN | Philadelphia | Pennsylvania |
| United States | Foothills Research Center - CCT | Phoenix | Arizona |
| United States | M3 Wake Research, Inc | Raleigh | North Carolina |
| United States | Clinical Research Partners LLC - Richmond - ERN | Richmond | Virginia |
| United States | DM Clinical Research | River Forest | Illinois |
| United States | Artemis Institute For Clinical Research LLC - Riverside - Headlands | Riverside | California |
| United States | Rochester Clinical Research, Inc | Rochester | New York |
| United States | Velocity Clinical Research, Rockville | Rockville | Maryland |
| United States | Peninsula Research Associates - CRN | Rolling Hills Estates | California |
| United States | St. Johns Center for Clinical Research - ERN | Saint Augustine | Florida |
| United States | Sundance Clinical Research, LLC | Saint Louis | Missouri |
| 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 | Clinical Trials of Texas, Inc. | San Antonio | Texas |
| United States | Acclaim Clinical Research | San Diego | California |
| United States | Optimal Research, LLC | San Diego | California |
| United States | Optimus Medical Group | San Francisco | California |
| United States | Velocity Clinical Research, Savannah | Savannah | Georgia |
| United States | South Ogden Family Medicine Ogden Clinic/CCT Research | South Ogden | Utah |
| United States | Spartanburg Medical Research | Spartanburg | South Carolina |
| United States | Bio-Kinetic Clinical Applications, LLC dba QPS-MO | Springfield | Missouri |
| United States | CRA, Headlands LLC | Stockbridge | Georgia |
| United States | DM Clinical Research | Sugar Land | Texas |
| United States | Javara Inc. | Sugar Land | Texas |
| United States | New Tampa Health, Inc. | Tampa | Florida |
| United States | Fiel Family & Sports Medicine - PC - CCT | Tempe | Arizona |
| United States | Synexus Clinical Research US, Inc. - The Villages | The Villages | Florida |
| United States | DM Clinical Research | Tomball | Texas |
| United States | Oakland Medical Research | Troy | Michigan |
| United States | Noble Clinical Research | Tucson | Arizona |
| United States | DelRicht Research | Tulsa | Oklahoma |
| United States | Velocity Clinical Research - Valparaiso | Valparaiso | Indiana |
| United States | Velocity Clinical Research, Inc. | Vestal | New York |
| United States | Chase Medical Research LLC - Waterbury | Waterbury | Connecticut |
| United States | Alliance for Multispecialty Research, LLC | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| ModernaTX, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Geometric Mean Titer (GMT) of Serum Antibody Level as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 | Day 29 | ||
| Primary | 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. | Day 29 | |
| Primary | Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 7 (7 days after vaccination) | ||
| Primary | Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 28 (28 days after vaccination) | ||
| Primary | 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 | ||
| Secondary | Percentage of Participants with HAI Titer of =1:40 at Day 29 | Day 29 | ||
| Secondary | Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 | Baseline (Day 1), Day 29 |
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