A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
Public ClinicalTrials.gov record NCT05975060. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3 Open-Label Study to Evaluate the Safety and Immunogenicity of an XBB.1.5 (Omicron Subvariant) SARS CoV-2 rS Vaccine Booster Dose in Previously mRNA COVID 19 Vaccinated and Baseline SARS CoV 2 Seropositive COVID-19 Vaccine Naïve Participants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05975060
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 660 participants
Conditions and interventions
Conditions
Interventions
- XBB.1.5 Vaccine (Booster) Biological
- XBB.1.5 Vaccine (single dose) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 54 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 7, 2023 (Actual)
- Primary completion
- Nov 15, 2023 (Actual)
- Completion
- May 20, 2024 (Actual)
- Last update posted
- May 30, 2024
2023 – 2024
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AMR | Mobile | Alabama | 36608 | — |
| Benchmark Research | Sacramento | California | 95864 | — |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80918 | — |
| AMR LLC-Miami | Coral Gables | Florida | 33134 | — |
| AMR | Fort Myers | Florida | 33912 | — |
| Health Awareness,LLC | Jupiter | Florida | 33458 | — |
| Tekton Research | Lawrenceville | Georgia | 30046 | — |
| Alliance for Multispecialty RSCH | Newton | Kansas | 67114 | — |
| Tekton Research | Wichita | Kansas | 67218 | — |
| AMR New Orleans | New Orleans | Louisiana | 70119 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| AMR | Kansas City | Missouri | 64114 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Velocity Clinical Research | Norfolk | Nebraska | 68701 | — |
| AMR | Las Vegas | Nevada | 89119 | — |
| AXCES Research | Albuquerque | New Mexico | 87109 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Tekton Research | Yukon | Oklahoma | 73099 | — |
| DM Clinical Research | Philadelphia | Pennsylvania | 19147 | — |
| AMR | Knoxville | Tennessee | 37909 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| Tekton Research | Beaumont | Texas | 77706 | — |
| Pan American clinical Research,LLC | Brownsville | Texas | 78520 | — |
| Benchmark Research | Fort Worth | Texas | 76135 | — |
| Research For Your Health | Plano | Texas | 75093 | — |
| Tekton Research | San Antonio | Texas | 78229 | — |
| AMR Layton Research Centre | Layton | Utah | 84041 | — |
| Health Research of Hampton Roads | Newport News | Virginia | 23606 | — |
| University of Washington | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05975060, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 30, 2024 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05975060 live on ClinicalTrials.gov.