Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05596734 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
A Phase 2 study of COVID-19 and Influenza, Human, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,019
- Enrollment target
- 20
- Study locations
NCT05596734: Completed Phase 2 study of COVID-19 and Influenza, Human, sponsored by BioNTech SE.
NCT05596734 is a Phase 2 study of COVID-19 and Influenza, Human that has completed, run by BioNTech SE. The registered enrollment target is 1,019 participants, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05596734, a Phase 2 study of COVID-19 and Influenza, Human, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,019 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (\>) 2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) a
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 |
What the finished NCT05596734 record still lists
NCT05596734 is an interventional study that assigns participants to a tested intervention. Its 1,019 participants enrollment target places it among the larger protocols in the corpus, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower).
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.
NCT05596734 names 20 study sites across 4 states, led by Florida, California, Alabama.
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.
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).
Who is sponsoring clinical trial NCT05596734?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05596734's enrollment target sits among peer trials
1,019 69th of 298 higher than 230 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Arginine Replacement Therapy in COVID-19
RECRUITING · Phase 2
-
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
RECRUITING · Phase 2
-
A Nasal Treatment for COVID-19
RECRUITING · Phase 2
-
Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
RECRUITING · Phase 2
-
Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
RECRUITING · Phase 2
-
Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02178163 · 1,020 participants · NA
Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
- NCT05225428 · 1,020 participants · NA
Video Education With Result Dependent dIsclosure
- NCT06697600 · 1,020 participants · NA
A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
- NCT06760637 · 1,020 participants · Phase 3
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI