NCT03814590View on ClinicalTrials.gov

A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

1,053

Participants

Timeline

Start Date

January 21, 2019

Primary Completion Date

December 12, 2019

Study Completion Date

November 30, 2020

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.

Trial Locations (21)

2610

GSK Investigational Site, Wilrijk

3000

GSK Investigational Site, Leuven

9000

GSK Investigational Site, Ghent

14609

GSK Investigational Site, Rochester

21075

GSK Investigational Site, Elkridge

28401

GSK Investigational Site, Wilmington

28602

GSK Investigational Site, Hickory

29303

GSK Investigational Site, Spartanburg

29464

GSK Investigational Site, Mt. Pleasant

30281

GSK Investigational Site, Stockbridge

32216

GSK Investigational Site, Jacksonville

33143

GSK Investigational Site, Miami

44122

GSK Investigational Site, Cleveland

64114

GSK Investigational Site, Kansas City

66219

GSK Investigational Site, Lenexa

67207

GSK Investigational Site, Wichita

68134

GSK Investigational Site, Omaha

76135

GSK Investigational Site, Fort Worth

77081

GSK Investigational Site, Houston

78229

GSK Investigational Site, San Antonio

97504

GSK Investigational Site, Medford

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03814590 - A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults | Biotech Hunter | Biotech Hunter