Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines
Public ClinicalTrials.gov record NCT05973006. 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 3, Randomized, Double-Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adolescents Previously Vaccinated With mRNA COVID-19 Vaccines
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a large-scale investigation (Phase 3) into a new booster shot designed specifically for teenagers. The booster targets a particular variant of COVID-19, Omicron XBB.1.5. The main focus is on safety: researchers want to see if this new booster is safe for teenagers who have already received two doses of the Pfizer or Moderna mRNA COVID-19 vaccines. To ensure a fair comparison, the study will use a double-blind approach. This means two groups of teenagers will receive booster shots, but neither the teenagers nor the researchers giving the shots will know beforehand which version of the booster each person gets. The study will also assess how well the body fights the virus after the booster shot.
Study identification
- NCT ID
- NCT05973006
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
- NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine Biological
- Prototype/XBB.1.5 Bivalent Vaccine (5 µg) Biological
Biological
Eligibility (public fields only)
- Age range
- 11 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 16, 2023 (Actual)
- Primary completion
- Apr 1, 2024 (Actual)
- Completion
- Sep 30, 2024 (Actual)
- Last update posted
- Jul 15, 2025
2023 – 2024
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alfa Medical Research | Davie | Florida | 33024 | — |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | — |
| ITB Research | Miami | Florida | 33173 | — |
| Velocity Clinical Research | Meridian | Idaho | 83642 | — |
| DM Clinical Research - Chicago | River Forest | Illinois | 60305 | — |
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | — |
| Alliance for Multispecialty Research, LLC (AMR) | Newton | Kansas | 67114 | — |
| AMR | Wichita | Kansas | 67207 | — |
| Velocity Clinical Research | Lafayette | Louisiana | 70508 | — |
| Velocity Clinical Research | Vestal | New York | 13850 | — |
| Velocity Clinical Research | Cincinnati | Ohio | 45246 | — |
| Tekton Research | Tulsa | Oklahoma | 74137 | — |
| Clinical Research Associates, Inc | Nashville | Tennessee | 37203 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| South Texas Clinical Research | Corpus Christi | Texas | 78404 | — |
| DM Clinical Research | Houston | Texas | 77065 | — |
| Medical Colleagues of Texas, LLP | Katy | Texas | 77450 | — |
| Research Your Health | Plano | Texas | 75093 | — |
| Tekton Research | San Antonio | Texas | 78244 | — |
| Mountain View CCT Research | Pleasant View | Utah | 84404 | — |
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 NCT05973006, 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 Jul 15, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05973006 live on ClinicalTrials.gov.