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NCT05260437 · ClinicalTrials.gov registry record · Phase 1
Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants
A Phase 1 study of COVID-19 and SARS-CoV-2, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
- 20
- Study locations
NCT05260437: Completed Phase 1 study of COVID-19 and SARS-CoV-2, sponsored by GlaxoSmithKline.
NCT05260437 is a Phase 1 study of COVID-19 and SARS-CoV-2 that has completed, run by GlaxoSmithKline. The registered enrollment target is 99 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05260437, a Phase 1 study of COVID-19 and SARS-CoV-2, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prevention of COVID-19 caused by SARS-CoV-2.
Primary Outcome
An AESI (serious or nonserious) is defined as an AE or SAE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Conditions Studied
Interventions
- BIOLOGICAL CV2CoV (2 µg)
- BIOLOGICAL CV2CoV (4 µg)
- BIOLOGICAL CV2CoV (8 µg)
- BIOLOGICAL CV2CoV (12 µg)
- BIOLOGICAL CV2CoV (16 µg)
Study Locations (20)
Florida
- GSK Investigational Site - Hallandale
- MD Clinical - Velocity - Hallandale
- GSK Investigational Site - Lakeland
- Accel Research Sites - Lakeland
- GSK Investigational Site - Miami
- Suncoast Research Group LLC - ERN-PPDS - Miami
- GSK Investigational Site - Palm Springs
Oklahoma
- GSK Investigational Site - Norman
- Lynn Institute of Norman - ERN - PPDS - Norman
- GSK Investigational Site - Oklahoma City
- Lynn Health Science Institute - Oklahoma City
Texas
- GSK Investigational Site - Cedar Park
- GSK Investigational Site - Dallas
- GSK Investigational Site - Dallas
- Research Your Health - Elite - Plano
Illinois
- Affinity Health Corp - Oak Brook
- GSK Investigational Site - Oak Brook
Ohio
- GSK Investigational Site - Cleveland
- Velocity Clinical Research - Cleveland - Cleveland
Colorado
- Lynn Institute of Denver - ERN - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2022-03-24 |
| Est. Completion | 2023-03-07 |
| Phase | Phase 1 |
What the finished NCT05260437 record still lists
NCT05260437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 5 interventions - of which CV2CoV (2 µg) is the first listed.
NCT05260437 names 20 study sites across 6 states, led by Florida, Oklahoma, Texas.
Frequently Asked Questions
What is clinical trial NCT05260437 about?
NCT05260437 is a clinical study titled "Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants". Prevention of COVID-19 caused by SARS-CoV-2.
What is the current status of trial NCT05260437?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2022-03-24. Estimated completion is 2023-03-07.
What conditions does trial NCT05260437 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV-2.
What interventions are being tested in trial NCT05260437?
The interventions under investigation include: CV2CoV (2 µg) (BIOLOGICAL), CV2CoV (4 µg) (BIOLOGICAL), CV2CoV (8 µg) (BIOLOGICAL), CV2CoV (12 µg) (BIOLOGICAL), CV2CoV (16 µg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05260437?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05260437 being conducted?
This trial has 20 study locations across Colorado, Florida, Illinois, Ohio, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05260437's enrollment target sits among peer trials
99 204th of 298 higher than 95 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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