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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2023-09-07 |
| Est. Completion | 2024-05-20 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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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Read our methodology - how this data is sourced, computed, and verified.
Related
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