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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: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.
NCT04762511 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The solicited administration site events are pain, redness and swelling.
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 |
Why NCT04762511 stopped before completion
NCT04762511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo (saline) is the first listed.
NCT04762511 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04762511's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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