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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
NCT05596734 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- BIOLOGICAL QIV
- BIOLOGICAL bivalent BNT162b2 (original/Omi BA.4/BA.5)
- BIOLOGICAL qIRV (22/23)
- BIOLOGICAL bIRV
- BIOLOGICAL tIRV
Study Locations (20)
Florida
- Proactive Clinical Research,LLC — Fort Lauderdale
- Finlay Medical Research — Greenacres City
- Indago Research & Health Center, Inc — Hialeah
- Research Centers of America ( Hollywood ) — Hollywood
- Angels Clinical Research Institute — Miami
- Miami Clinical Research — Miami
- Gerardo Polanco, MD — Miami
- Research Institute of South Florida — Miami
- Entrust Clinical Research — Miami
- Jackson Medical Group Cardiac Care — Miami
- Miami Dade Medical Research Institute, LLC — Miami
- Palm Springs Community Health Center — Miami Lakes
California
- Orange County Research Center — Lake Forest
- Orange County Heart Institute — Orange
- California Research Foundation — San Diego
- Orange County Research Center — Tustin
Alabama
- North Alabama Research Center — Athens
- The Heart Center — Athens
Arizona
- HOPE Research Institute — Phoenix
- The Pain Center of Arizona — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,019 participants |
| Start Date | 2022-10-28 |
| Est. Completion | 2023-12-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05596734
The ClinicalTrials.gov registry entry for NCT05596734 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,019 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 5 interventions — of which QIV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05596734 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05596734 about?
NCT05596734 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza". 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 ...
What is the current status of trial NCT05596734?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,019 participants. The study started on 2022-10-28. Estimated completion is 2023-12-28.
What conditions does trial NCT05596734 study?
This clinical trial studies the following conditions: COVID-19, Influenza, Human. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05596734?
The interventions under investigation include: QIV (BIOLOGICAL), bivalent BNT162b2 (original/Omi BA.4/BA.5) (BIOLOGICAL), qIRV (22/23) (BIOLOGICAL), bIRV (BIOLOGICAL), tIRV (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05596734?
This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05596734 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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