A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza
Public ClinicalTrials.gov record NCT05052697. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA IN HEALTHY INDIVIDUALS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB) Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either: * 1 of 4 dose levels of mIRV (either A or B Strain), * 1 of 4 dose levels of bIRV (containing both A and B strains), * qIRV (at 1 dose level), or * A licensed quadrivalent influenza vaccine (QIV). At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2: * mIRV encoding A strain at dose level 4, or * mIRV encoding B strain at dose level 4. Substudy B This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age: 2-Visit Schedules * 2 doses of qIRV (at a dose level 1), administered 21 days apart. * 2 doses of licensed QIV, administered 21 days apart (as a control group) * A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart. 1-Visit Schedules * A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2. * A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1. * A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations). * A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3. * 1 dose of licensed QIV (as a control group). Substudy B In participants 18 to 64 years of age: -A dose of qIRV encoding 2 A strains and 2 B strains at a dose level combination 1 or 2.
Study identification
- NCT ID
- NCT05052697
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 1,158 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 13, 2021 (Actual)
- Primary completion
- Jan 27, 2023 (Actual)
- Completion
- Jan 27, 2023 (Actual)
- Last update posted
- Mar 12, 2024
2021 – 2023
United States locations
- U.S. sites
- 100
- U.S. states
- 22
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Alabama Research Center | Athens | Alabama | 35611 | — |
| The Heart Center | Athens | Alabama | 35611 | — |
| Arizona Heart Rhythm Center | Phoenix | Arizona | 85016 | — |
| HOPE Research Institute | Phoenix | Arizona | 85018 | — |
| The Pain Center of Arizona | Phoenix | Arizona | 85018 | — |
| Noble Clinical Research | Tucson | Arizona | 85704 | — |
| Pima Heart and Vascular | Tucson | Arizona | 85704 | — |
| Inland Valley Cardiovascular Center | Murrieta | California | 92563 | — |
| Orange County Heart Institute | Orange | California | 92868 | — |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Pediatrics-Infectious Diseases - Clinical Trials Center at University of Colorado Anschutz Medical C | Aurora | Colorado | 80045 | — |
| UCHealth Heart and Vascular Center - Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Yale Cardiology | New Haven | Connecticut | 06519 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | — |
| Alliance for Multispecialty Research, LLC | Coral Gables | Florida | 33134 | — |
| Halifax Health Medical Center | Daytona Beach | Florida | 32114 | — |
| NYU Langone Cardiology Associates | Delray Beach | Florida | 33484 | — |
| First Coast Heart & Vascular Center | Fleming Island | Florida | 32003 | — |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | — |
| Proactive Clinical Research,LLC | Fort Lauderdale | Florida | 33308 | — |
| Alliance for Multispecialty Research, LLC | Fort Myers | Florida | 33912 | — |
| Millennium Physician Group | Fort Myers | Florida | 33912 | — |
| Robert B. Pritt, DO | Fort Myers | Florida | 33912 | — |
| Direct Helpers Research Center. | Hialeah | Florida | 33012 | — |
| Best Quality Research,Inc. | Hialeah | Florida | 33016 | — |
| Elixia Infectious Disease, LLC | Hollywood | Florida | 33024 | — |
| First Coast Heart & Vascular Center | Jacksonville | Florida | 32216 | — |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | — |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | — |
| Premier Cardiology and Vascular Associates | Maitland | Florida | 32751 | — |
| LMG Research | Miami | Florida | 33125 | — |
| Millennium Clinical Research | Miami | Florida | 33125 | — |
| Optimus U Corporation | Miami | Florida | 33125 | — |
| Suncoast Research Group | Miami | Florida | 33135 | — |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| University of Miami Hospital | Miami | Florida | 33136 | — |
| Dr Gerardo A. Polanco, MD | Miami | Florida | 33156 | — |
| Research Institute of South Florida | Miami | Florida | 33173 | — |
| Entrust Clinical Research | Miami | Florida | 33176 | — |
| Jackson Medical Group Cardiac Care | Miami | Florida | 33176 | — |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| Central Florida Cardiology Group | Orlando | Florida | 32803 | — |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | — |
| DBC Research USA | Pembroke Pines | Florida | 33029 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| My Cardiologist | South Miami | Florida | 33143 | — |
| Precision Clinical Research | Sunrise | Florida | 33351 | — |
| Genesis Clinical Research, LLC | Tampa | Florida | 33603 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Centricity Research Columbus Georgia Multispecialty | Columbus | Georgia | 31904 | — |
| IACT Health | Columbus | Georgia | 31904 | — |
| IACT Health | Rincon | Georgia | 31326 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67205 | — |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67207 | — |
| Heartland Cardiology, LLC | Wichita | Kansas | 67226 | — |
| Centennial Medical Group | Elkridge | Maryland | 21075 | — |
| Associates of Cardiology | Silver Spring | Maryland | 20910 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Pioneer Heart Institute | Lincoln | Nebraska | 68506 | — |
| Velocity Clinical Research, Norfolk | Norfolk | Nebraska | 68701 | — |
| Meridian Clinical Research - 3345 North 107th Street | Omaha | Nebraska | 68134 | — |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | — |
| Sanjay Vohra, MD, F.A.C.C. | Henderson | Nevada | 89074 | — |
| Wr-Crcn, Llc. | Las Vegas | Nevada | 89106 | — |
| Excel Clinical Research, LLC | Las Vegas | Nevada | 89109 | — |
| Las Vegas Clinical Trials | North Las Vegas | Nevada | 89030 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Penn Medicine | Somers Point | New Jersey | 08244 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| NYU Langone - Center for the Prevention of Cardiovascular Disease | New York | New York | 10016 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Rochester General Hospital Infectious Disease | Rochester | New York | 14621 | — |
| Rochester General Hospital | Rochester | New York | 14621 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Upstate Health Care Center-University Cardiovascular Group of Syracuse | Syracuse | New York | 13202 | — |
| SUNY Upstate Medical University Global Health Research Unit | Syracuse | New York | 13215 | — |
| M3-Emerging Medical Research, LLC | Durham | North Carolina | 27704 | — |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28303 | — |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Aventiv Research Inc. | Columbus | Ohio | 43213 | — |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | — |
| Columbus Cardiovascular Associates, Inc | Columbus | Ohio | 43213 | — |
| Pennsylvania Heart and Vascular Group | Jenkintown | Pennsylvania | 19046 | — |
| Main Street Physician's Care | Little River | South Carolina | 29566 | — |
| Prolato Clinical Research Center | Houston | Texas | 77054 | — |
| DM Clinical Research | Houston | Texas | 77065 | — |
| DM Clinical Research | Humble | Texas | 77338 | — |
| Cedar Health Research | Irving | Texas | 75062 | — |
| Harmony Heart Group | Plano | Texas | 75093 | — |
| Mt Olympus Medical Research | Sugar Land | Texas | 77479 | — |
| DM Clinical Research | Tomball | Texas | 77375 | — |
| Northwest Heart Center | Tomball | Texas | 77375 | — |
| Centricity Research Suffolk Primary Care | Suffolk | Virginia | 23435 | — |
| Sentara BelleHarbour | Suffolk | Virginia | 23435 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05052697, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05052697 live on ClinicalTrials.gov.