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Rabies Vaccine

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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 three 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.

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Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted common.study.methods.is-healthy-no

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

Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 3 doses of RG SAM (CNE) low dose formulation, administered intramuscularly, according to a 0, 2, 6-month schedule (i.e. at Days 1, 61 and 181).

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

Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 3 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly, according to a 0, 2, 6-month schedule (i.e. at Days 1, 61 and 181).

Biological - High dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

Subjects in the High dose (Hd-) RG SAM (CNE) group will receive 3 doses of RG SAM (CNE) high dose formulation, administered intramuscularly, according to a 0, 2, 6-month schedule (i.e. at Days 1, 61 and 181).

Drug - Saline Placebo

Subjects in the Saline Placebo group will receive 3 doses of saline Placebo, administered intramuscularly, according to a 0, 2, 6-month schedule (i.e. at Days 1, 61 and 181).

Biological - RabAvert

Subjects in the RabAvert Group will receive 3 doses of RabAvert vaccine, administered intramuscularly, according to a 0, 2, 6-month schedule (i.e. at Day 1, 61 and 181).

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Safety and Immunogenicity of GSK's Rabies G SAM (CNE) Vaccine [GSK3903133A] in Healthy Adults

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NCT04062669

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