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NCT04758962 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety of and Immune Response to Varying Doses of a Vaccine Against COVID-19 in Healthy Adults
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT04758962: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT04758962 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04758962, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, reactogenicity and immune response of a self-amplifying mRNA (SAM) lipid nanoparticle (LNP) platform with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike antigen (CoV-2 SAM \[LNP\] vaccine) in ascending doses when administered intramuscularly (IM) on a 0,1-month schedule to healthy adults 18 to 50 years of age. There will be no administration of escalated doses of the study vaccine.
Primary Outcome
The solicited administration site adverse events assessed were pain, redness and swelling.
Interventions
- BIOLOGICAL 1 µg CoV2 SAM (LNP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2022-04-19 |
| Phase | Phase 1 |
What the finished NCT04758962 record still lists
NCT04758962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which 1 µg CoV2 SAM (LNP) is the first listed.
NCT04758962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04758962 about?
NCT04758962 is a clinical study titled "A Study of the Safety of and Immune Response to Varying Doses of a Vaccine Against COVID-19 in Healthy Adults". The purpose of this study is to assess the safety, reactogenicity and immune response of a self-amplifying mRNA (SAM) lipid nanoparticle (LNP) platform with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike antigen (CoV-2 SAM \[LNP\] vaccine) in ascending doses when administered int...
What is the current status of trial NCT04758962?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-02-15. Estimated completion is 2022-04-19.
What interventions are being tested in trial NCT04758962?
The interventions under investigation include: 1 µg CoV2 SAM (LNP) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04758962?
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 NCT04758962's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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