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NCT06680375 · ClinicalTrials.gov registry record · Phase 1
A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults
A Phase 1 study of COVID-19, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 9
- Study locations
NCT06680375: Completed Phase 1 study of COVID-19, sponsored by GlaxoSmithKline.
NCT06680375 is a Phase 1 study of COVID-19 that has completed, run by GlaxoSmithKline. The registered enrollment target is 106 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06680375, a Phase 1 study of COVID-19, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study will evaluate the reactogenicity, safety, and immune response of Flu Seasonal/SARS-CoV-2 mRNA (mRNA Flu/COVID-19) combination vaccine. The flu portion will target multiple strains of the flu virus, while the COVID-19 part will focus on the spike protein of the SARS-CoV-2 virus. Both parts of this vaccine have been tested individually before. This will be the first study to test the combined vaccine in humans in healthy adult participants.
Primary Outcome
Food and Drug Administration (FDA) toxicity grading scales for biochemistry hematology parameters are evaluated. Grades are defined as follows: Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe; Grade 4 -Potentially life threatening.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Flu Seasonal /SARS-CoV-2 mRNA Dose 1
- COMBINATION_PRODUCT Flu Seasonal /SARS-CoV-2 mRNA Dose 2
- COMBINATION_PRODUCT Flu Seasonal mRNA
- COMBINATION_PRODUCT SARS-CoV-2 mRNA Dose 1
- COMBINATION_PRODUCT SARS-CoV-2 mRNA Dose 2
Study Locations (9)
Florida
- GSK Investigational Site - Hialeah
- GSK Investigational Site - Miami
- GSK Investigational Site - Miami
Alabama
- GSK Investigational Site - Anniston
California
- GSK Investigational Site - Rolling Hills Estates
Kansas
- GSK Investigational Site - Lenexa
Missouri
- GSK Investigational Site - St Louis
Nebraska
- GSK Investigational Site - Omaha
New York
- GSK Investigational Site - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2024-11-11 |
| Est. Completion | 2025-06-09 |
| Phase | Phase 1 |
What the finished NCT06680375 record still lists
NCT06680375 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 5 interventions - of which Flu Seasonal /SARS-CoV-2 mRNA Dose 1 is the first listed.
NCT06680375 lists 9 locations in 7 states (Florida, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT06680375 about?
NCT06680375 is a clinical study titled "A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults". This study will evaluate the reactogenicity, safety, and immune response of Flu Seasonal/SARS-CoV-2 mRNA (mRNA Flu/COVID-19) combination vaccine. The flu portion will target multiple strains of the flu virus, while the COVID-19 part will focus on the spike protein of the SARS-CoV-2 virus. Both parts...
What is the current status of trial NCT06680375?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2024-11-11. Estimated completion is 2025-06-09.
What conditions does trial NCT06680375 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT06680375?
The interventions under investigation include: Flu Seasonal /SARS-CoV-2 mRNA Dose 1 (COMBINATION_PRODUCT), Flu Seasonal /SARS-CoV-2 mRNA Dose 2 (COMBINATION_PRODUCT), Flu Seasonal mRNA (COMBINATION_PRODUCT), SARS-CoV-2 mRNA Dose 1 (COMBINATION_PRODUCT), SARS-CoV-2 mRNA Dose 2 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06680375?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06680375 being conducted?
This trial has 9 study locations across Alabama, California, Florida, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06680375's enrollment target sits among peer trials
106 196th of 298 higher than 103 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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