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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04758962
The ClinicalTrials.gov registry entry for NCT04758962 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 1 µg CoV2 SAM (LNP) is the first listed.
NCT04758962 reports 0 study locations.
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.
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