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NCT04062669 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults
A Phase 1 study of Virus Diseases, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 4
- Study locations
NCT04062669: Completed Phase 1 study of Virus Diseases, sponsored by GlaxoSmithKline.
NCT04062669 is a Phase 1 study of Virus Diseases that has completed, run by GlaxoSmithKline. The registered enrollment target is 160 participants, below the 1,502-participant average among 7 other Virus Diseases trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04062669, a Phase 1 study of Virus Diseases, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this first time-in-human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of different dose levels of an experimental rabies glycoprotein G (RG) vaccine (RG-SAM \[CNE\] vaccine), made using a new technology, when administered intramuscularly (IM) on a 0, 2, 6 \*-month schedule to healthy adults. \* There will be no vaccinations with the third dose of any of the study treatments.
Primary Outcome
The following local AEs are solicited: pain, redness and swelling at injection site.
Conditions Studied
Interventions
- DRUG Saline Placebo
- BIOLOGICAL Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
- BIOLOGICAL Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
- BIOLOGICAL Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
- BIOLOGICAL Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
Study Locations (4)
Florida
- GSK Investigational Site - South Miami
Kansas
- GSK Investigational Site - Lenexa
Maryland
- GSK Investigational Site - Baltimore
New York
- GSK Investigational Site - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2022-07-01 |
| Phase | Phase 1 |
What the finished NCT04062669 record still lists
NCT04062669 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 1,502-participant average among 7 other Virus Diseases trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Virus Diseases appearing as the primary indexed condition, and to 5 interventions - of which Saline Placebo is the first listed.
NCT04062669 reports a single indexed study location in Florida, Kansas, Maryland.
Frequently Asked Questions
What is clinical trial NCT04062669 about?
NCT04062669 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults". The purpose of this first time-in-human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of different dose levels of an experimental rabies glycoprotein G (RG) vaccine (RG-SAM \[CNE\] vaccine), made using a new technology, when administered intramuscularly (IM) on a 0, 2, 6 ...
What is the current status of trial NCT04062669?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2019-08-13. Estimated completion is 2022-07-01.
What conditions does trial NCT04062669 study?
This clinical trial studies the following conditions: Virus Diseases.
What interventions are being tested in trial NCT04062669?
The interventions under investigation include: Saline Placebo (DRUG), Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A) (BIOLOGICAL), Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A) (BIOLOGICAL), Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A) (BIOLOGICAL), Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04062669?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04062669 being conducted?
This trial has 4 study locations across Florida, Kansas, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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