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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: Completed Phase 2 study of COVID-19, sponsored by Novavax.
NCT05975060 is a Phase 2 study of COVID-19 that has completed, run by Novavax. The registered enrollment target is 660 participants, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine assessed at Day 28 following study vaccination.
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 |
What the finished NCT05975060 record still lists
NCT05975060 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower).
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 names 20 study sites across 16 states, led by 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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Where NCT05975060's enrollment target sits among peer trials
660 96th of 298 higher than 202 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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