Seasonal Influenza Clinical Trial
Official title:
A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older
| Verified date | January 2024 |
| Source | ModernaTX, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older.
| Status | Completed |
| Enrollment | 22510 |
| Est. completion date | January 5, 2024 |
| Est. primary completion date | January 5, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 50 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 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 the first dose on 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 the Screening visit. - Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the US CDC or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening visit. - 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, immunocompromising/ immunosuppressive condition, asplenia, or recurrent severe infections. - Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein. - Participant has received systemic immunosuppressant drugs for >14 days in total within 180 days prior to the Screening visit (for glucocorticosteroids, =10 milligrams (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. - Participant has received any vaccine authorized or approved by local health agency =28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention. - Participant is unaware whether they have received an influenza vaccine in the previous influenza season. - Participant received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to Day 1 - Participant has tested positive for influenza by local health authority-approved testing methods within 180 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 study. Note: Other inclusion and exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | MHAT Sveti Ivan Rilski | Kozloduy | |
| Bulgaria | MC City Clinic Sveti Georgi - Montana | Montana | |
| Bulgaria | MHAT "Dr. Stamen Iliev | Montana | |
| Bulgaria | Medical Center Medconsult Pleven | Pleven | |
| Bulgaria | Military Medical Academy | Sofia | |
| Bulgaria | SHAT of Pneumo-phthisiatric diseases - Sofia District | Sofia | |
| Canada | Aggarwal and Associates LTD | Brampton | |
| Canada | Aviva Clinical Trials Group Inc | Burlington | |
| Canada | Hamilton Medical Research Group | Hamilton | |
| Canada | Okanagan Clinical Trials | Kelowna | |
| Canada | Centricity Research Quebec City | Levis | |
| Canada | Milestone Research Inc. | London | |
| Canada | Yang Medicine | Ottawa | |
| Canada | LMC Manna | Pointe-Claire | |
| Canada | Alpha Recherche Clinique Inc | Quebec | |
| Canada | Clinique de Lebourgneuf | Quebec | |
| Canada | Clinique spécialisée en allergie - Allergy/Immunology/Asthma/Mpoc | Quebec | |
| Canada | DIEX Research Quebec Inc. | Quebec | |
| Canada | DIEX Research Quebec Inc. | Quebec | |
| Canada | Diex Research Sherbrooke Inc | Quebec | |
| Canada | Central Alberta Research Clinic | Red Deer | |
| Canada | Diex Recherche - Joilette - HyperCore - PPDS | Saint-Charles-Borromée | |
| Canada | Glencar Medical Inc. | Sarnia | |
| Canada | Canadian Phase Onward Inc. | Toronto | |
| Canada | LMC | Toronto | |
| Canada | Manna Research | Toronto | |
| Canada | Medicine Professional Corporation | Toronto | |
| Canada | Toronto Western Hospital | Toronto | |
| Canada | Diex Recherche Trois-Rivières | Trois-Rivieres | |
| Canada | Colchester East Hants Health Authority - Colchester Regional | Truro | |
| Canada | Diex Recherche Victoriaville | Victoriaville | |
| Denmark | Aarhus Universitetshospital | Århus N | |
| Denmark | Odense University Hospital | Odense | |
| Denmark | Sjællands UniHosp, Roskilde - Medicine and Infectious Diseases | Roskilde | |
| Estonia | Center for Clinical and Basic Research | Tallinn | |
| Estonia | Innomedica OÜ | Tallinn | |
| Estonia | Merelahe Family Doctors Centre | Tallinn | |
| Estonia | Clinical Research Center | Tartu | |
| Germany | Berliner Centrum für Reise- und Tropenmedizin | Berlin | |
| Germany | Emovis GmbH | Berlin | |
| Germany | Klinische Forschung Berlin | Berlin | |
| Germany | Klinische Forschung Berlin-Mitte GmbH | Berlin | |
| Germany | Klinische Forschung Dresden GmbH | Dresden | |
| Germany | Medizentrum Essen Borbeck | Essen | |
| Germany | IKF Pneumologie | Frankfurt | |
| Germany | Infektiologikum Frankfurt-Sachsenhausen | Frankfurt | |
| Germany | Studienzentrum Dr. Keller | Frankfurt/Main | |
| Germany | Clinical Research Hamburg GmbH | Hamburg | |
| Germany | Klinische Forschung Hamburg GmbH | Hamburg | |
| Germany | Klinische Forschung Hannover-Mitte GmbH | Hannover | |
| Germany | Siteworks GmbH | Hannover | |
| Germany | Siteworks GmbH | Heidelberg | |
| Germany | University Hospital Cologne AöR | Köln | |
| Germany | Synexus Clinical Research GmbH | Leipzig | |
| Germany | Praxis Illies | Magdeburg | |
| Germany | Dermatologie Quist | Mainz | |
| Germany | Praxis Schaum | Oldenburg | |
| Germany | Klinische Forschung Schwerin GmbH | Schwerin | |
| Germany | Hautarztpraxis Leitz & Kollegen | Stuttgart | |
| Germany | Studienzentrum Brinkum | Wardenburg | |
| Netherlands | Leids Universitair Medisch Centrum (LUMC) | Leiden | |
| Netherlands | Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care | Utrecht | |
| Poland | Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | |
| Poland | Centrum Medyczne Plejady | Krakow | |
| Poland | Krakowskie Centrum Medyczne Sp. z o.o. | Kraków | |
| Poland | Centrum Medyczne AMED Oddzial w Lodzi | Lodz | |
| Poland | ETG Lublin | Lublin | |
| Poland | KO-MED Centra Kliniczne Lublin II | Lublin | |
| Poland | ETG Skierniewice | Skierniewice | |
| Poland | Centrum Innowacyjnych Terapii Sp. z o.o. | Warszawa | |
| Poland | Provita Centrum Medyczne Sp. z o.o. | Warszawa | |
| Poland | RCMed | Warszawa | |
| Poland | ETG Zamosc | Zamosc | |
| Poland | KO-MED Centra Kliniczne Sp. z o.o. | Zamosc | |
| Spain | Hospital de Antequera | Antequera | |
| Spain | Hospital Clinic De Barcelona | Barcelona | |
| Spain | Hospital Santa Creu i Sant Pau - Research institut | Barcelona | |
| Spain | Universitat Autonoma de Barcelona (UAB) - Institut d'Investigacio en Atencio Primaria Jordi Gol (IDIAP Jordi Gol) | Barcelona | |
| Spain | Hospital Alvaro Cunqueiro | Vigo | |
| Spain | Hospital Povisa | Vigo | |
| Taiwan | Kaohsiung Veterans General Hospital | Kaohsiung City | |
| Taiwan | China Medical University Hospital - division of Rheumatology - Taichung | Taichung | |
| Taiwan | National Cheng Kung University hospital | Tainan | |
| Taiwan | National Taiwan University Hospital - Family Medicine | Taipei | |
| Taiwan | Taipei Medical University - Taipei Medical University Hospital | Taipei | |
| Taiwan | Taipei Medical University - WanFang Hospital | Taipei | |
| Taiwan | Tri-Service General Hospital - Neihu Branch - Infectious Diseases | Taipei | |
| United Kingdom | Royal United Hospital | Bath | |
| United Kingdom | Layton Medical Centre | Blackpool | |
| United Kingdom | Hull University Teaching Hospitals NHS Foundation trust | Hull | |
| United Kingdom | University Hospitals of Leicester-Leicester Royal Hospital | Leicester | |
| United Kingdom | Liverpool University Hospitals NHS Foundation Trust - Aintree University Hospital (Fazakerley Hospital) | Liverpool | |
| United Kingdom | GST NHS Found | London | |
| United Kingdom | Newcastle University - Institute of Cellular Medicine (ICM) | Newcastle | |
| United Kingdom | Panthera Biopartners - Manchester - multispeciality | Rochdale | |
| United Kingdom | Panthera Biopartners - Sheffield - multispeciality | Rochdale | |
| United Kingdom | Panthera Biopartners - Preston - multispeciality | Salford | |
| United Kingdom | Southampton General Hospital | Southampton | |
| United Kingdom | Royal Cornwall Hospitals Trust - Respiratory | Truro | |
| United States | Radiant Research | Akron | Ohio |
| United States | Velocity Clinical Research, Greenville | Anderson | South Carolina |
| United States | Privia Medical Group | Annapolis | Maryland |
| United States | North Alabama Research Center, LLC | Athens | Alabama |
| United States | Tekton Research, Inc | Austin | Texas |
| United States | Velocity Clinical Research, Banning | Banning | California |
| United States | Meridian Clinical Research | Baton Rouge | Louisiana |
| United States | Platinum Research Network, LLC | Beaumont | Texas |
| United States | Paul G Matherne MD | Biloxi | Mississippi |
| United States | United Medical Associates | Binghamton | New York |
| United States | Cope Family Medicine | Bountiful | Utah |
| United States | Hope Clinical Research, LLC | Canoga Park | California |
| United States | Tekton Research, Inc. | Chamblee | Georgia |
| United States | Tryon Medical Group | Charlotte | North Carolina |
| United States | Great Lakes Clinical Trials LLC | Chicago | Illinois |
| United States | Great Lakes Clinical Trials LLC | Chicago | Illinois |
| United States | CTI Clinical Research Center | Cincinnati | Ohio |
| United States | Sterling Research Group | Cincinnati | Ohio |
| United States | Velocity Clinical Research - Cincinnati | Cincinnati | Ohio |
| United States | Velocity Clinical Research - Columbia | Columbia | South Carolina |
| United States | Southeast Regional Research Group | Columbus | Georgia |
| United States | MedPharmics | Covington | Louisiana |
| United States | Nature Coast Clinical Research, LLC - Crystal River | Crystal River | Florida |
| United States | Zenos Clinical Research | Dallas | Texas |
| United States | iResearch Atlanta, LLC | Decatur | Georgia |
| United States | Velocity Clinical Research, Denver | Denver | Colorado |
| United States | CCT Research at Skyline Medical Center, PC | Elkhorn | Nebraska |
| United States | Carolina Institute for Clinical Research | Fayetteville | North Carolina |
| United States | Arthritis & Rheumatology - Clinic of Northern Colorado | Fort Collins | Colorado |
| United States | Benchmark Research | Fort Worth | Texas |
| United States | CCT Research / Methodist Physicians Clinic, Prairie Fields Family Medicine, PC | Fremont | Nebraska |
| United States | Velocity Clinical Research, Gaffney | Gaffney | South Carolina |
| United States | Lenzmeier Family Medicine | Glendale | Arizona |
| United States | Meridian Clinical Research | Grand Island | Nebraska |
| United States | Velocity Clinical Research - Grants Pass | Grants Pass | Oregon |
| United States | Velocity Clinical Research - Greenville | Greenville | South Carolina |
| United States | DELRICHT RESEARCH at GULFPORT MEMORIAL | Gulfport | Mississippi |
| United States | Great Lakes Clinical Trials LLC | Gurnee | Illinois |
| United States | Delricht Research | Hendersonville | Tennessee |
| United States | Floridian Clinical Research | Hialeah | Florida |
| United States | Homestead Associates in Research,Inc | Hialeah | Florida |
| United States | Olympus Family Medicine/CCT Research | Holladay | Utah |
| United States | Broward Research Group | Hollywood | Florida |
| United States | DM Clinical Research | Houston | Texas |
| United States | Texas Center for Drug Development, Inc. | Houston | Texas |
| United States | Marvel Clinical Research | Huntington Beach | California |
| United States | Citrus Cardiology Consultants | Inverness | Florida |
| United States | Encore Research Group-Jacksonville Center for Clinical Resea | Jacksonville | Florida |
| United States | Health Awareness, Inc | Jupiter | Florida |
| United States | Velocity Clinical Research, Chula Vista | La Mesa | California |
| United States | Velocity Clinical Research, San Diego | La Mesa | California |
| United States | Multi-Therapeutic Research Associates, Inc. | Lake City | Florida |
| United States | Accel Research Sites - Lakeland | Lakeland | Florida |
| United States | CCT Research | Las Vegas | Nevada |
| United States | Clinical Research Center of Nevada LLC | Las Vegas | Nevada |
| United States | Santa Rosa Medical Centers of Nevada/ CCT Research | Las Vegas | Nevada |
| United States | Johnson County Clin-Trials (JCCT) | Lenexa | Kansas |
| United States | Be Well Clinical Studies, LLC | Lincoln | Nebraska |
| United States | Baptist Health Center for Clinical Research | Little Rock | Arkansas |
| United States | Lynn Institute of the Ozarks | Little Rock | Arkansas |
| United States | Longmont Medical Research Network | Longmont | Colorado |
| United States | Velocity Clinical Research - Westlake | Los Angeles | California |
| United States | ARS - Meridien Research | Maitland | Florida |
| United States | DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE | McKinney | Texas |
| United States | Velocity Clinical Resarch - Medford | Medford | Oregon |
| United States | Velocity Clinical Research - Boise | Meridian | Idaho |
| United States | Medpharmics, LLC | Metairie | Louisiana |
| United States | Clinical Trials of Florida, LLC | Miami | Florida |
| United States | Miami centre of clinical research | Miami | Florida |
| United States | South Florida Research Center, Inc. | Miami | Florida |
| United States | Suncoast Research Associates Trials, LLC | Miami | Florida |
| United States | Global Health Research Center | Miami Lakes | Florida |
| United States | Montana Medical Research, Inc | Missoula | Montana |
| United States | Diabetes & Endocrinology Consultants | Morehead City | North Carolina |
| United States | Carolina Health Specialists | Myrtle Beach | South Carolina |
| United States | Nathan H Fischman MD LLC | New Orleans | Louisiana |
| United States | Heartland Research Associates LLC | Newton | Kansas |
| United States | In-Quest Medical Research | Norcross | Georgia |
| United States | Medpace, Inc. - Clinical Pharmacology Unit (CPU) | Norfolk | Nebraska |
| United States | Meridian Clinical Research | Norfolk | Nebraska |
| United States | Las Vegas Clinical Trials, LLC | North Las Vegas | Nevada |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Meridian Clinical Research - Omaha | Omaha | Nebraska |
| United States | Midwest Regional Health Services, LLC/CCT Research | Omaha | Nebraska |
| United States | Papillon Research Centre | Omaha | Nebraska |
| United States | Innovation Medical Research Center,inc | Palmetto Bay | Florida |
| United States | CCT Research | Phoenix | Arizona |
| United States | Research Your Health | Plano | Texas |
| United States | Empire Clinical Research | Pomona | California |
| United States | Meridian Clinical Research | Portsmouth | Virginia |
| United States | M3 Wake Research, Inc. | Raleigh | North Carolina |
| United States | Black Hills Center for American Indian Health | Rapid City | South Dakota |
| United States | Epic Medical Research, LLC | Red Oak | Texas |
| United States | Clinical Research Partners, LLC | Richmond | Virginia |
| United States | Chicago Health Medical Group | River Forest | Illinois |
| United States | Artemis Institute for Clinical Research | Riverside | California |
| United States | Benchmark Research-Texas | Riverside | California |
| United States | Rochester Clinical Research, Inc | Rochester | New York |
| United States | Rockville Internal Medicine Group | Rockville | Maryland |
| United States | Peninsula Research Associates (PRA) | Rolling Hills Estates | California |
| United States | Sundance Clinical Research, LLC | Saint Louis | Missouri |
| United States | CenExel - JBR | Salt Lake City | Utah |
| United States | Clinical Trials of Texas, Inc | San Antonio | Texas |
| United States | Acclaim Clinical Research | San Diego | California |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | Medical Center for Clinical Research | San Diego | California |
| United States | Women's Health Care Research Corp. | San Diego | California |
| United States | Shawn K Hassler MD | San Francisco | California |
| United States | West Coast Research LLC | San Ramon | California |
| United States | Mount Vernon Clinical Research | Sandy Springs | Georgia |
| United States | Meridian Clinical Research - Savannah | Savannah | Georgia |
| United States | Meridian Clinical Research - Dakota Dunes | Sioux City | Iowa |
| United States | South Ogden Family Medicine clinic/CCT | South Ogden | Utah |
| United States | DM Clinical Research - Detroit | Southfield | Michigan |
| United States | Spartanburg Regional Health Services | Spartanburg | South Carolina |
| United States | Delricht Research | Springfield | Massachusetts |
| United States | National Medical University and Embryonic Tissues Center EmC | Springfield | Missouri |
| United States | Clinical Research Atlanta | Stockbridge | Georgia |
| United States | Lakeview Medical Center | Suffolk | Virginia |
| United States | Breco Research - A Tarheel Clinical Research Site | Sugar Land | Texas |
| United States | DM Clinical Research | Sugar Land | Texas |
| United States | Velocity Clinical Research - Syracuse | Syracuse | New York |
| United States | New Tampa Health, Inc | Tampa | Florida |
| United States | Fiel Family and Sports Medicine/CCT Research | Tempe | Arizona |
| United States | Noble Clinical Research | Tucson | Arizona |
| United States | Delricht Research Tulsa | Tulsa | Oklahoma |
| United States | Velocity Clinical Research - Valparaiso | Valparaiso | Indiana |
| United States | Velocity Clinical Research - Providence | Warwick | Rhode Island |
| United States | Velocity Clinical Research - Salt Lake City | West Jordan | Utah |
| United States | Alliance for Multispecialty Research | Wichita | Kansas |
| United States | PMG Research of Wilmington | Wilmington | North Carolina |
| United States | Trial Management Associates | Wilmington | North Carolina |
| United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
| United States | Platinum Research Network, LLC | Yukon | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| ModernaTX, Inc. |
United States, Bulgaria, Canada, Denmark, Estonia, Germany, Netherlands, Poland, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Solicited Local and Systemic Reactogenicity 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 Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation | Day 1 through Day 361 | ||
| Primary | Time to First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR) Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Influenza A or B Virus Strains | 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later | ||
| Secondary | Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains with Similarity to the Vaccine Strains | Similarity to strains selected for the seasonal vaccine will be determined by antigenicity testing and/or genomic sequencing. | 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later | |
| Secondary | Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains Antigenically Matched to the Vaccine Strains | Antigenically matched to strains selected for the seasonal vaccine will be determined by antigenicity testing. | 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later | |
| Secondary | Time to First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Virus Strains | Any strains include any influenza A or B strains, influenza A or B strains with similarity to vaccine strains and influenza A or B strains that are antigenically matched to vaccine strains. Antigenically matched to strains selected for the seasonal vaccine will be determined by antigenicity testing. | 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later | |
| Secondary | Time to First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Influenza A or B | Any influenza A or B strains regardless of antigenic match to strains selected for the seasonal vaccine. A positive result for influenza infection by viral culture is needed, following a positive result for influenza infection by RT-PCR. |
14 days post-vaccination through Day 181 or end of influenza season, whichever ends later | |
| Secondary | Time to First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Influenza A or B | Any influenza A or B strains regardless of antigenic match to strains selected for the seasonal vaccine. A positive result for influenza infection by viral culture is needed, following a positive result for influenza infection by RT-PCR |
14 days post-vaccination through Day 181 or end of influenza season, whichever ends later | |
| Secondary | Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI | 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later | ||
| Secondary | Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay | Day 29 | ||
| Secondary | Number of Participants Reaching Seroconversion as measured by HAI Assay | Seroconversion is defined as either a prevaccination HAI titer <1:10 and a postvaccination titer =1:40 or a prevaccination HAI titer =1:10 and a minimum 4-fold rise in postvaccination HAI antibody titer. | Day 29 | |
| Secondary | Number of Participants with a Titer =1:40 as Measured by HAI Assay | Day 29 | ||
| Secondary | Change from Baseline in Geometric Mean Fold Rise (GMFR) at Day 29 as Measured by HAI Assay | Baseline, Day 29 |
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