A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
Influenza, Human
About this trial
This is an interventional prevention trial for Influenza, Human focused on measuring Grippe, Flu, Influenza, Vaccine, RNA vaccine
Eligibility Criteria
Inclusion Criteria:
- Male or female participants ≥18 years of age at Visit 1 (Day 1).
- Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria:
- Medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Allergy to egg proteins (egg or egg products) or chicken proteins.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
- Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
- Any participant who has received or plans to receive a modRNA-platform SARS CoV-2 vaccine within 14 days before or after study vaccination at Visit 1.
- Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Sites / Locations
- North Alabama Research Center
- St. Vincent's Birmingham Hospital
- Accel Research Sites - Birmingham Clinical Research Unit
- Accel Research Sites Network - Birmingham Clinical Research Unit
- Ross Bridge Medical Practice, LLC-CCT Research
- SEC Clinical Research
- Lakeview Clinical Research
- Medical Affiliated Research Center
- Lenzmeier Family Medicine/CCT Research
- Aventiv Research
- Desert Clinical Research/ CCT Research
- Dignity Health Medical Group Family Medicine - St. Joseph's
- St. Joseph's Hospital and Medical Center
- HOPE Research Institute
- The Pain Center of Arizona
- HOPE Research Institute - Phoenix
- HOPE Research Institute
- Foothills Research Center/ CCT Research
- Epic Medical Research - Surprise
- Fiel Family and Sports Medicine, PC/CCT Research
- HOPE Research Institute
- Noble Clinical Research
- Baptist Health Center for Clinical Research
- Applied Research Center of Arkansas
- Anaheim Clinical Trials
- Velocity Clinical Research, Banning
- Benchmark Research
- Ascada Health PC dba Ascada Research
- Ascada Research
- Marvel Clinical Research
- Velocity Clinical Research, Huntington Park
- Velocity Clinical Research, San Diego
- Ark Clinical ResearchRecruiting
- Ark Clinical Research
- Kaiser Permanente
- Velocity Clinical Research, Westlake.Recruiting
- Velocity Clinical Research, Westlake
- Velocity Clinical Research, North Hollywood
- Center for Clinical Trials, LLC
- Empire Clinical Research
- Paradigm Clinical Research Centers, Inc
- Peninsula Research Associates
- Benchmark Research
- Artemis Institute for Clinical Research
- Wr-McCr, Llc
- California Research Foundation
- Encompass Clinical Research
- Premiere Medical Center
- Premiere Medical CenterRecruiting
- Collaborative Neuroscience Research, LLC
- Collaborative Neuroscience Research, LLC
- Ark Clinical Research - Tustin
- Orange County Research Center
- Diablo Clinical Research, Inc.
- Lynn Institute of Denver
- Tekton Research, Inc
- Tekton Research, Inc.
- Paradigm Clinical Research Centers, Inc
- New England Research Associates, LLC
- Clinical Research Consulting
- New Haven Clinical Research Unit
- Yale Cardiology
- Yale University School of Medicine
- Stamford Therapeutics Consortium
- Washington Health Institute
- JEM Research Institute
- Tampa Bay Medical Research
- Alliance for Multispecialty Research, LLC
- Universal Axon Clinical Research, LLC
- Fleming Island Center for Clinical Research
- Proactive Clinical Research,LLC
- Alliance for Multispecialty Research, LLC
- Robert B. Pritt, DO
- Best Quality Research,Inc.
- Jacksonville Center for Clinical Research
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
- Health Awareness
- Wr-Msra.Llc
- Accel Research Sites Network - Lakeland Clinical Research Unit
- Accel Research Sites - St. Petersburg Clinical Research Unit
- Accel Research Sites Network - St. Pete-Largo Clinical Research UnitRecruiting
- Accel Research Sites Network - Maitland Clinical Research Unit
- Palm Springs Community Health Center
- Palm Springs Community Health Center
- Gerardo Polanco, MD
- Care Research Center Inc
- Entrust Clinical Research
- Miami Dade Medical Research Institute, LLC
- Clinical Neuroscience Solutions, Inc.
- Headlands Research Orlando
- Innovation Medical Research CenterRecruiting
- Innovation Medical Research Center
- DBC Research USA
- United Medical Research
- Accel Research Sites - St. Petersburg Clinical Research UnitRecruiting
- Genesis Clinical Research, LLC
- Angels Clinical Research Institute
- Clinical Site Partners LLC, dba CSP Orlando
- IACT Health
- IACT Health
- Centricity Research Rincon Pulmonology
- AGILE Clinical Research Trials, LLC
- WR-Mount Vernon Clinical Research, LLC
- iResearch Savannah
- Javara - Privia Medical Group Georgia - Savannah
- Meridian Clinical Research, LLC
- Clinical Research Atlanta
- Rophe Adult and Pediatric Medicine/SKYCRNG
- East-West Medical Research Institute
- Clinical Research Prime
- Solaris Clinical Research
- Koch Family Medicine
- Accellacare - DuPage
- MediSphere Medical Research Center - Evansville - West Franklin Street
- MediSphere Medical Research Center - EAST
- Velocity Clinical Research, Valparaiso
- University of Iowa
- Velocity Clinical Research, Sioux City
- Alliance for Multispecialty Research, LLC
- Alliance for Multispecialty Research, LLC
- Alliance for Multispecialty Research, LLC
- Alliance for Multispecialty Research, LLC
- Versailles Family Medicine / CCT Research
- MedPharmics, LLC
- DelRicht Research
- Alliance for Multispecialty Research, LLC
- Louisiana State University Health Sciences Shreveport
- Pharmaron
- Advanced Primary and Geriatric Care - CCT Research
- Jadestone Clinical Research
- Brigham and Women's Hospital
- Boston Medical Center
- ActivMed Practices and Research
- University of Massachusetts Chan Medical School
- Henry Ford Hospital
- Ascension St. John Hospital
- Revival Research Institute
- Oakland Medical Research
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
- Clinical Research Professionals
- Saint Louis University Center for Vaccine Development
- Sundance Clinical Research
- Bio-Kinetic Clinical Applications, LLD dba QPS-MO
- QPS Bio-Kinetic Clinical Applications (Patient Screening Only)
- Bozeman Health Deaconess Hospital
- Methodist Physicians Clinic/CCT Research
- Meridian Clinical Research, LLC.
- Velocity Clinical Research, Grand Island
- Be Well Clinical Studies
- Meridian Clinical Research, LLC
- Quality Clinical Research
- Velocity Clinical Research, Omaha
- Papillion Research Center/CCT Research
- Excel Clinical Research, LLC
- Santa Rosa Medical Centers of Nevada / CCT Research
- ActivMed Practices & Research, LLC.
- David Jurist Research Building
- Hackensack University Medical Center Medical Plaza
- Hackensack University Medical Center
- South Jersey Infectious Disease
- Albuquerque Clinical Trials, Inc.
- Velocity Clinical Research, Albuquerque
- Velocity Clinical Research, AlbuquerquRecruiting
- Velocity Clinical Research, Albuquerque
- Smith Allergy & Asthma Specialists
- NYU Langone HealthRecruiting
- NYU Langone Health
- Rochester Clinical Research, LLC
- Velocity Clinical Research, Vestal
- Accellacare - Cary
- Accellacare - CharlotteRecruiting
- Accellacare - Charlotte
- Carolina Institute for Clinical Research
- PharmQuest Life Sciences, LLC
- Accellacare - Hickory
- Monroe Biomedical Research
- Accellacare - Raleigh
- M3 Wake Research Associates
- Accellacare - Rocky Mount
- Accellacare - Salisbury
- Accellacare - Wilmington
- Trial Management Associates - Wilmington - Floral Parkway
- Trial Management Associates, LLC
- Accellacare - Winston-Salem
- Plains Clinical Research Center
- Plains Medical Clinic, LLC
- CTI Clinical Research Center
- Meridian Clinical Research, LLC
- Cincinnati Children's Hospital Medical Center
- University Hospitals Cleveland Medical Center
- Senders Pediatrics
- Velocity Clinical Research, Cleveland
- Centricity Research Columbus Ohio Multispecialty
- Dayton Clinical Research
- PriMED Clinical ResearchRecruiting
- Hometown Urgent Care & Occupational HealthRecruiting
- WellNow Urgent Care & Research
- PriMED Clinical Research
- WellNow Urgent Care and ResearchRecruiting
- Tekton Research, Inc.
- Tekton Research, Inc.
- Lynn Institute of Norman
- Lynn Health Science Institute
- Tekton Research, Inc
- Tekton/ Primary Health Partners
- Velocity Clinical Research, Medford
- Kaiser Permanente Northwest Center for Health Research
- Lehigh Valley Health Network
- Capital Area Research, LLC
- Central Erie Primary Care
- Velocity Clinical Research, Providence
- Velocity Clinical Research, Anderson
- Pharmacorp Clinical Trials
- Velocity Clinical Research, Columbia
- Velocity Clinical Research, Gaffney
- Tribe Clinical Research, LLC
- Main Street Physician's Care
- Clinical Trials of South Carolina
- Trial Management Associates
- Coastal Carolina Research Center
- Velocity Clinical Research, Spartanburg
- Velocity Clinical Research, Union
- Accellacare - BristolRecruiting
- Internal Medicine and Pediatric Associates of Bristol
- WR-Clinsearch, LLC
- Holston Medical Group
- Alliance for Multispecialty Research, LLC
- New Phase Research and Development
- Accellacare US Inc., d/b/a Accellacare of Knoxville
- Accellacare US Inc., d/b/a Accellacare of Knoxville
- PMG Research, Inc. d/b/a PMG Research of KnoxvilleRecruiting
- Clinical Neuroscience Solutions Inc.
- Clinical Neuroscience Solutions, Inc. dba CNS HealthcareRecruiting
- Elligo Clinical Research CenterRecruiting
- Elligo Clinical Research Center
- Benchmark Research
- Elligo Clinical Research CenterRecruiting
- Tekton Research, Inc
- Orion Clinical Research
- Headlands Research - Brownsville
- Velocity Clinical Research, Austin
- WR-Global Medical Research, LLC
- DFW Clinical Research
- North Texas Infectious Diseases Consultants, P.A
- Proactive Clinical Research, LLC
- Benchmark Research
- Texas Health Family Care
- Allure Health
- Trio Clinical Trials
- Juno Research
- Prolato Clinical Research Center
- DM Clinical Research-Bellaire
- Texas Center for Drug Development, Inc.
- Santa Clara Family Clinic
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
- Milton Haber, MD
- SMS Clinical Research
- AIM Trials, LLC
- Epic Medical Research
- Clinical Trials of Texas, LLC
- IMA Clinical Research San Antonio
- Tekton Research - Fredericksburg Road
- Javara - Privia Medical Group North Texas - Stephenville
- Sugar Lakes Family Practice
- DM Clinical Research
- Northwest Houston Heart Center
- Crossroads Clinical Research
- Cope Family Medicine / CCT ResearchRecruiting
- Cope Family Medicine / CCT Research
- South Ogden Family Medicine/ CCT Research
- J. Lewis Research, Inc. / Foothill Family Clinic
- Olympus Family Medicine/CCT Research
- J. Lewis Research, Inc. / Foothill Family Clinic South
- J. Lewis Research, Inc. / Jordan River Family Medicine
- Springville Dermatology - Springville/CCT Research
- Velocity Clinical Research, Salt Lake City
- Clinical Alliance for Research and Education - Infectious Diseases (CARE-ID), LLC
- Charlottesville Medical Research
- Virginia Research Center
- Health Research of Hampton Roads, Inc.
- Alliance for Multispecialty Research, LLC
- Meridian Clinical Research LLC
- Clinical Research Partners, LLC
- Centricity Research Suffolk Primary Care
- EvergreenHealth Medical Center
- EvergreenHealth
- Rainier Clinical Research Center
- Kaiser Permanente Washington Health Research Institute
- Seattle Clinical Research Center
- Allegiance Research Specialists, LLC
- Fundacion Estudios ClinicosRecruiting
- Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.LRecruiting
- Hospital Militar Central Cirujano Mayor Dr. Cosme ArgerichRecruiting
- Obras Sociais Irma Dulce
- Infection Control
- Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
- Centro de Referência e Treinamento DST/AIDS
- A2Z Clinical Centro Avançado de Pesquisa Clínica - Valinhos
- Instituto de Infectologia Emilio Ribas
- CEPIC - Centro Paulista de Investigação Clínica
- Clinical Research Chile SpA
- Enroll SpARecruiting
- Centro Skin Med LimitadaRecruiting
- CECIMRecruiting
- Pacific Clinical Research Network - RotoruaRecruiting
- P3 Research - TaurangaRecruiting
- Pacific Clinical Research Network - ForteRecruiting
- P3 Research - Hawke's BayRecruiting
- Lakeland Clinical Trials WaikatoRecruiting
- Lakeland Clinical Trials WellingtonRecruiting
- Southern Clinical Trials TotaraRecruiting
- Optimal Clinical Trials NorthRecruiting
- Optimal Clinical Trials
- Optimal Clinical TrialsRecruiting
- Southern Clinical Trials TasmanRecruiting
- P3 Research - WellingtonRecruiting
- West Visayas State University Medical CenterRecruiting
- Health Cube Medical ClinicsRecruiting
- Tropical Disease FoundationRecruiting
- Mary Johnston HospitalRecruiting
- Lung Center of the Philippines
- Far Eastern University Nicanor Reyes Medical FoundationRecruiting
- Adventist Hospital PalawanRecruiting
- Cebu Doctors University Hospital
- De La Salle Health Sciences InstituteRecruiting
- De La Salle Medical and Health Sciences InstituteRecruiting
- St. Paul's Hospital of Iloilo Inc.Recruiting
- St. Paul's Hospital of Iloilo, Inc.Recruiting
- Iloilo Doctors' HospitalRecruiting
- Philippine General HospitalRecruiting
- Far Eastern University Nicanor Reyes Medical Foundation
- Synergy Biomed Research InstituteRecruiting
- Nelson Mandela Academic Clinical Research Unit (NeMACRU)
- Phoenix PharmaRecruiting
- Iatros International
- Josha ResearchRecruiting
- Global Clinical TrialsRecruiting
- Worthwhile Clinical TrialsRecruiting
- ReimedRecruiting
- Soweto Clinical Trials CentreRecruiting
- Wits Clinical Research
- Clinresco CentresRecruiting
- Ubuntu Clinical Research - KrugersdorpRecruiting
- Ubuntu Clinical Research - LenasiaRecruiting
- Zinakekele Medicall CentreRecruiting
- Jongaie Research
- Emmed ResearchRecruiting
- Botho Ke Bontle Health ServicesRecruiting
- Wits Clinical ResearchRecruiting
- Setshaba Research CentreRecruiting
- Synexus Watermeyer Clinical Research CentreRecruiting
- FCRN Clinical Trial CentreRecruiting
- Precise Clinical Solutions
- Private Practice - Dr. Peter SebastianRecruiting
- Synapta Clinical Research Centre
- Synapta Clinical Research CentreRecruiting
- Private Practice - Dr. Neyaseelan Gounden
- Ndlovu Research Centre
- MERCLINCO MiddleburgRecruiting
- Aurum Institute - Rustenburg
- Synexus - Helderberg Clinical Research Centre - Somerset West
- TREAD ResearchRecruiting
- TASK Applied Science
- Tiervlei Trial CentreRecruiting
- Setshaba Research Centre
- Umzimkhulu Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Quadrivalent influenza modRNA vaccine, 18 through 64 years of age
Quadrivalent influenza vaccine, 18 through 64 years of age
Quadrivalent influenza modRNA vaccine, ≥65 years of age
Quadrivalent influenza vaccine, ≥65 years of age
Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age
Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age
Quadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age
Licensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age