A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

August 13, 2019

Primary Completion Date

July 28, 2021

Study Completion Date

July 1, 2022

Conditions
Virus Diseases
Interventions
BIOLOGICAL

Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) low dose formulation, administered intramuscularlyat Days 1 and 61.

BIOLOGICAL

Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 1 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly at Day 1.

BIOLOGICAL

Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

Subjects in the Lower dose (Lrd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lower dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)

BIOLOGICAL

Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

Subjects in the Lowest dose (Ltd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lowest dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)

DRUG

Saline Placebo

Subjects in the Saline Placebo group will receive 2 doses of saline Placebo, administered intramuscularly Day 1 and 61.

BIOLOGICAL

RabAvert

Subjects in the RabAvert Group will receive 2 doses of RabAvert vaccine, administered intramuscularly, at Days 1 and 61.

Trial Locations (4)

14609

GSK Investigational Site, Rochester

21201

GSK Investigational Site, Baltimore

33143

GSK Investigational Site, South Miami

66219

GSK Investigational Site, Lenexa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04062669 - A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults | Biotech Hunter | Biotech Hunter