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NCT06382311 · ClinicalTrials.gov registry record · Phase 1
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 991
- Enrollment target
NCT06382311: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT06382311 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 991 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1552% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06382311, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 991 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered in healthy adults 18 to 85 years of age.
Primary Outcome
The assessed solicited administration site events are pain at administration site, redness at administration site, swelling at administration site and lymphadenopathy.
Interventions
- BIOLOGICAL Flu Pandemic mRNA_Dose level 1
- BIOLOGICAL Flu Pandemic mRNA_Dose level 2
- BIOLOGICAL Flu Pandemic mRNA_ Dose level 3.
- BIOLOGICAL Flu Pandemic mRNA_ Dose level 4
- BIOLOGICAL Flu Pandemic mRNA_Dose level 5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 991 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2026-01-13 |
| Phase | Phase 1 |
What the finished NCT06382311 record still lists
NCT06382311 is an interventional study that assigns participants to a tested intervention. The registered 991 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1552% higher).
The record links to 0 conditions, and to 5 interventions - of which Flu Pandemic mRNA_Dose level 1 is the first listed.
NCT06382311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06382311 about?
NCT06382311 is a clinical study titled "A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults". The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered in healthy adults 18 to 85 years of age.
What is the current status of trial NCT06382311?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 991 participants. The study started on 2024-04-18. Estimated completion is 2026-01-13.
What interventions are being tested in trial NCT06382311?
The interventions under investigation include: Flu Pandemic mRNA_Dose level 1 (BIOLOGICAL), Flu Pandemic mRNA_Dose level 2 (BIOLOGICAL), Flu Pandemic mRNA_ Dose level 3. (BIOLOGICAL), Flu Pandemic mRNA_ Dose level 4 (BIOLOGICAL), Flu Pandemic mRNA_Dose level 5 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06382311?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06382311's enrollment target sits among peer trials
991 7th of 2000 higher than 1,994 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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