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NCT05975060 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.

A Phase 2 study of COVID-19, sponsored by Novavax.

Completed
Registry status
Phase 2
Development phase
660
Enrollment target
20
Study locations

NCT05975060 is a Phase 2 study of COVID-19 that has completed, run by Novavax. The registered enrollment target is 660 participants, below the 55,211-participant average among 203 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05975060, a Phase 2 study of COVID-19, has completed, sponsored by Novavax.

COMPLETED
Registry status
Phase 2
Development phase
660 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in previously mRNA COVID-19 vaccinated adult participants ≥18 years of age and baseline SARS CoV-2 seropositive COVID-19 vaccine naïve participants ≥18 years of age.

Conditions Studied

Interventions

  • BIOLOGICAL XBB.1.5 Vaccine (Booster)
  • BIOLOGICAL XBB.1.5 Vaccine (single dose)

Study Locations (20)

Florida

  • AMR LLC-Miami - Coral Gables
  • AMR - Fort Myers
  • Health Awareness,LLC - Jupiter

Kansas

  • Alliance for Multispecialty RSCH - Newton
  • Tekton Research - Wichita

Missouri

  • AMR - Kansas City
  • Sundance Clinical Research - St Louis

Alabama

  • AMR - Mobile

California

  • Benchmark Research - Sacramento

Colorado

  • Lynn Institute of the Rockies - Colorado Springs

Georgia

  • Tekton Research - Lawrenceville

Louisiana

  • AMR New Orleans - New Orleans

Trial Details

FieldValue
Enrollment Target 660 participants
Start Date 2023-09-07
Est. Completion 2024-05-20
Phase Phase 2

Sponsor

Novavax

31 total trials

What the Registry Record Tells You About NCT05975060

The ClinicalTrials.gov registry entry for NCT05975060 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,211-participant average among 203 other COVID-19 trials with a reported enrollment target (99% lower). The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which XBB.1.5 Vaccine (Booster) is the first listed.

NCT05975060 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Florida, Kansas, Missouri.

Frequently Asked Questions

What is clinical trial NCT05975060 about?

NCT05975060 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.". This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in previously mRNA COVID-19 va...

What is the current status of trial NCT05975060?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 660 participants. The study started on 2023-09-07. Estimated completion is 2024-05-20.

What conditions does trial NCT05975060 study?

This clinical trial studies the following conditions: COVID-19.

What interventions are being tested in trial NCT05975060?

The interventions under investigation include: XBB.1.5 Vaccine (Booster) (BIOLOGICAL), XBB.1.5 Vaccine (single dose) (BIOLOGICAL).

Who is sponsoring clinical trial NCT05975060?

This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05975060 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.