A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults
NCT03814590 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1053
Last updated 2022-08-05
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).
Conditions
- Respiratory Syncytial Virus Infections
Interventions
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) unadjuvanted low dose
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) unadjuvanted medium dose
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) unadjuvanted high dose
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
- BIOLOGICAL
-
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
- DRUG
-
Placebo (Saline solution)
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-01-21
- Primary Completion
- 2019-12-12
- Completion
- 2020-11-30
- FDA Drug
- Yes
Countries
- United States
- Belgium
Study Locations
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