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NCT04762511 · ClinicalTrials.gov registry record · Phase 1
A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT04762511 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 17 participants.
The verdict
NCT04762511, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this first-time-in-human (FTiH) study is to assess the reactogenicity, safety and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine, when administered intramuscularly (IM) on a 0, 2-month schedule to healthy participants aged 18-40 years.
Interventions
- DRUG Placebo (saline)
- BIOLOGICAL Lower dose formulation of HSV vaccine (GSK4108771A)
- BIOLOGICAL Low dose formulation of HSV vaccine (GSK4108771A)
- BIOLOGICAL Medium dose formulation of HSV vaccine (GSK4108771A)
- BIOLOGICAL High dose formulation of HSV vaccine (GSK4108771A)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2021-05-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04762511
The ClinicalTrials.gov registry entry for NCT04762511 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 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 5 interventions - of which Placebo (saline) is the first listed.
NCT04762511 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04762511 about?
NCT04762511 is a clinical study titled "A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years". The purpose of this first-time-in-human (FTiH) study is to assess the reactogenicity, safety and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine, when administered intramuscularly (IM) on a 0, 2-month schedule to healthy participants aged 1...
What is the current status of trial NCT04762511?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-03-02. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT04762511?
The interventions under investigation include: Placebo (saline) (DRUG), Lower dose formulation of HSV vaccine (GSK4108771A) (BIOLOGICAL), Low dose formulation of HSV vaccine (GSK4108771A) (BIOLOGICAL), Medium dose formulation of HSV vaccine (GSK4108771A) (BIOLOGICAL), High dose formulation of HSV vaccine (GSK4108771A) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04762511?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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