At a glance
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Phase I/II, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Subjects Aged 18-40 or 60-80 Years
In Brief
A Phase 2 clinical trial evaluating RSV Vaccine (GSK3844766A) unadjuvanted low dose, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, and 8 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 1,053 participants across 21 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years. As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B).
Study Details
Timeline
Interventions
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.