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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 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 55,209-participant average among 203 other COVID-19 trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 4 states.

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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).

Conditions Studied

COVID-19 Influenza, Human

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

FieldValue
Enrollment Target 1,019 participants
Start Date 2022-10-28
Est. Completion 2023-12-28
Phase Phase 2

Sponsor

BioNTech SE

53 total trials

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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, categorized as Phase 2. The registered enrollment target is 1,019 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,209-participant average among 203 other COVID-19 trials with a reported enrollment target (98% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.