A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults
Public ClinicalTrials.gov record NCT04062669. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Immunogenicity of GSK's Rabies G SAM (CNE) Vaccine [GSK3903133A] in Healthy Adults.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04062669
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Interventions
- 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
- Saline Placebo Drug
- RabAvert Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 40 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 12, 2019
- Primary completion
- Jul 27, 2021
- Completion
- Jun 30, 2022
- Last update posted
- Feb 29, 2024
2019 – 2022
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | South Miami | Florida | 33143 | — |
| GSK Investigational Site | Lenexa | Kansas | 66219 | — |
| GSK Investigational Site | Baltimore | Maryland | 21201 | — |
| GSK Investigational Site | Rochester | New York | 14609 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04062669, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 29, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04062669 live on ClinicalTrials.gov.