Influenza Clinical Trial
Official title:
A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults
| Verified date | December 2023 |
| Source | ModernaTX, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.
| Status | Active, not recruiting |
| Enrollment | 1231 |
| Est. completion date | November 29, 2024 |
| Est. primary completion date | November 29, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 79 Years |
| Eligibility | Key Inclusion Criteria: - Body mass index (BMI) of 18 kilograms (kg)/m2 to 35 kg/square meter (m^2) (inclusive) at the Screening Visit. - Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests. - For female participants 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, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding. - Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was =120 days prior to Day 1. Key Exclusion Criteria: - Participant is acutely ill or febrile (temperature =38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1. - Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. - Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Screening Visit (for glucocorticoids =10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed. - Participant has received or plans to receive any vaccine authorized or approved by a local health agency =28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. - Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1. - Participant tested positive for influenza by local health authority-approved testing methods =150 days prior to Day 1. - Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1. - Participant has donated =450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the clinical trial. Note: Other inclusion/exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Annapolis Internal Medicine | Annapolis | Maryland |
| United States | Benchmark Research | Austin | Texas |
| United States | Tekton Research | Austin | Texas |
| United States | Velocity Clinical research | Baton Rouge | Louisiana |
| United States | Tekton Research | Beaumont | Texas |
| United States | DM Clinical Research | Brookline | Massachusetts |
| United States | Chandler Clinical Trials | Chandler | Arizona |
| United States | DelRicht Research | Charleston | South Carolina |
| United States | Tryon Medical Partners | Charlotte | North Carolina |
| United States | CTI Clinical Research Center | Cincinnati | Ohio |
| United States | Velocity Clinical Research | Cincinnati | Ohio |
| United States | Velocity Clinical Research | Cincinnati | Ohio |
| United States | Benchmark Research | Colton | California |
| United States | Centricity Research | Columbus | Georgia |
| United States | Centricity Research | Columbus | Ohio |
| United States | WellNow Urgent Care & Research | Dayton | Ohio |
| United States | Vida Clinical Studies | Dearborn Heights | Michigan |
| United States | Accel Research Site | Decatur | Georgia |
| United States | CenExel iResearch | Decatur | Georgia |
| United States | Accel Research Sites | DeLand | Florida |
| United States | Medical Care | Elizabethton | Tennessee |
| United States | Benchmark Research | Fort Worth | Texas |
| United States | DelRicht Research | Gulfport | Mississippi |
| United States | Meridian Clinical Research | Hampton | Virginia |
| United States | DelRicht Research | Hendersonville | Tennessee |
| United States | CenExel | Hollywood | Florida |
| United States | Cyfair Clinical Research | Houston | Texas |
| United States | Texas Center for Drug Development | Houston | Texas |
| United States | Marvel Clinical Research | Huntington Beach | California |
| United States | Nature Coast Clinical Research | Inverness | Florida |
| United States | Jacksonville Center For Clinical Research | Jacksonville | Florida |
| United States | Clay Platte Family Medicine | Kansas City | Missouri |
| United States | CCT Research | Las Vegas | Nevada |
| United States | Excel Clinical Research | Las Vegas | Nevada |
| United States | Johnson County Clin-Trials | Lenexa | Kansas |
| United States | Lifeline Primary Care | Lilburn | Georgia |
| United States | Velocity Clinical Research | Lincoln | Nebraska |
| United States | Tekton Research | Longmont | Colorado |
| United States | Accel Research Sites | Maitland | Florida |
| United States | DelRicht Research | McKinney | Texas |
| United States | Benchmark Research | Metairie | Louisiana |
| United States | Suncoast Research Group | Miami | Florida |
| United States | Central Valley Research | Modesto | California |
| United States | Koch Family Medicine | Morton | Illinois |
| United States | Trial Management Associates | Myrtle Beach | South Carolina |
| United States | DelRicht Research | New Orleans | Louisiana |
| United States | Velocity Clinical Research | Norfolk | Nebraska |
| United States | Las Vegas Clinical Trials | North Las Vegas | Nevada |
| United States | Lynn Institute of East Oklahoma | Oklahoma City | Oklahoma |
| United States | Optimal Research | Peoria | Illinois |
| United States | DM Clinical Research | Philadelphia | Pennsylvania |
| United States | Mercado Medical Practice | Philadelphia | Pennsylvania |
| United States | CCT Research | Pleasant View | Utah |
| United States | Velocity Clinical Research | Portsmouth | Virginia |
| United States | DelRicht Research | Prairieville | Louisiana |
| United States | DM Clinical Research | River Forest | Illinois |
| United States | Rochester Clinical Research | Rochester | New York |
| United States | Velocity Clinical Research | Rockville | Maryland |
| United States | Ogden Clinic | Roy | Utah |
| United States | Benchmark Research | Sacramento | California |
| United States | JBR Clinical Research | Salt Lake City | Utah |
| United States | Benchmark Research | San Angelo | Texas |
| United States | Tekton Research | San Antonio | Texas |
| United States | DelRicht Research | Tulsa | Oklahoma |
| United States | Versailles Family Medicine | Versailles | Kentucky |
| United States | Wenatchee Valley Hospital & Clinics Campus | Wenatchee | Washington |
| United States | Tekton Research | Wichita | Kansas |
| United States | Trial Management Associates | Wilmington | North Carolina |
| United States | Tekton Research Inc | Yukon | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| ModernaTX, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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) and Severe AEs | Up to Day 28 (28 days after vaccination) | ||
| Primary | Number of Participants With Unsocilited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study | Day 1 through Day 181 | ||
| Secondary | Change From Baseline in Geometric Mean Titer (GMT) of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay | Baseline (Day 1), Day 29, and Day 181 | ||
| Secondary | Change From Baseline in GMT of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) | Baseline (Day 1), Day 29, and Day 181 | ||
| Secondary | Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay | Baseline (Day 1), Day 29, and Day 181 | ||
| Secondary | Change From Baseline in GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA | Baseline (Day 1), Day 29, and Day 181 | ||
| Secondary | Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay | Seroconversion is defined as a Day 29 and Day 181 titer =1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is =1:10 in anti-HA antibodies measured by HAI assay. | Baseline (Day 1) to Day 29, and Day 181 | |
| Secondary | SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA | Seroresponse is defined as a Day 29 and Day 181 titer =4-fold if baseline is =lower limit of quantification (LLOQ) or =4*LLOQ if baseline titer is | Baseline (Day 1) to Day 29, and Day 181 |
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