A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
Public ClinicalTrials.gov record NCT05596734. 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 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either: * qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations * qIRV (22/23) at dose level 1, * qIRV (22/23) at dose level 2, or * bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV). Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).
Study identification
- NCT ID
- NCT05596734
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,019 participants
Conditions and interventions
Conditions
Interventions
- bivalent BNT162b2 (original/Omi BA.4/BA.5) Biological
- qIRV (22/23) Biological
- QIV Biological
- bIRV Biological
- tIRV Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Oct 28, 2022 (Actual)
- Primary completion
- Dec 28, 2023 (Actual)
- Completion
- Dec 28, 2023 (Actual)
- Last update posted
- Jul 23, 2025
2022 – 2023
United States locations
- U.S. sites
- 59
- U.S. states
- 22
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Alabama Research Center | Athens | Alabama | 35611 | — |
| The Heart Center | Athens | Alabama | 35611 | — |
| HOPE Research Institute | Phoenix | Arizona | 85018 | — |
| The Pain Center of Arizona | Phoenix | Arizona | 85018 | — |
| Orange County Research Center | Lake Forest | California | 92630 | — |
| Orange County Heart Institute | Orange | California | 92868 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Proactive Clinical Research,LLC | Fort Lauderdale | Florida | 33308 | — |
| Finlay Medical Research | Greenacres City | Florida | 33467 | — |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | — |
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | — |
| Angels Clinical Research Institute | Miami | Florida | 33122 | — |
| Miami Clinical Research | Miami | Florida | 33155 | — |
| Gerardo 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 | — |
| Palm Springs Community Health Center | Miami Lakes | Florida | 33014 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| Palm Springs Community Health Center | Miami Lakes | Florida | 33016 | — |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | — |
| DBC Research USA | Pembroke Pines | Florida | 33029 | — |
| United Medical Research | Port Orange | Florida | 32127 | — |
| Velocity Clinical Research, Savannah | Savannah | Georgia | 31406 | — |
| Savannah Medical Group | Savannah | Georgia | 31419 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois | 60640 | — |
| Retina Associates | Elmhurst | Illinois | 60126 | — |
| Affinity Health | Oak Brook | Illinois | 60523 | — |
| Alliance for Multispecialty Research, LLC | Oak Brook | Illinois | 60523 | — |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67207 | — |
| Jadestone Clinical Research | Silver Spring | Maryland | 20904 | — |
| Michigan Center of Medical Research (MICHMER) | Farmington Hills | Michigan | 48334 | — |
| Pradeep Chandra, DO, FACC | Bridgeton | Missouri | 63044 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Pioneer Heart Institute | Lincoln | Nebraska | 68506 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114 | — |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | — |
| ActivMed Practices & Research, LLC. | Portsmouth | New Hampshire | 03801 | — |
| SUNY Upstate Medical University Institute for Global Health | Syracuse | New York | 13215 | — |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | — |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | — |
| Main Street Physician's Care | Little River | South Carolina | 29566 | — |
| McLeod Cardiology Associates - Little River | Little River | South Carolina | 29566 | — |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37909 | — |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37920 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| Prolato Clinical Research Center | Houston | Texas | 77054 | — |
| DM Clinical Research, Martin Diagnostic Clinic | Tomball | Texas | 77375 | — |
| DM Clinical Research | Tomball | Texas | 77375 | — |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | — |
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 NCT05596734, 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 Jul 23, 2025 · 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 NCT05596734 live on ClinicalTrials.gov.