Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women

PHASE2CompletedINTERVENTIONAL
Enrollment

507

Participants

Timeline

Start Date

March 20, 2015

Primary Completion Date

July 2, 2015

Study Completion Date

June 21, 2016

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

RSV vaccine GSK3003895A (formulation 1)

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

BIOLOGICAL

RSV vaccine GSK3003898A (formulation 2)

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

BIOLOGICAL

RSV vaccine GSK3003899A (formulation 3)

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

BIOLOGICAL

Boostrix

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

Trial Locations (12)

3004

GSK Investigational Site, Melbourne

13210

GSK Investigational Site, Syracuse

23554

GSK Investigational Site, Lübeck

40509

GSK Investigational Site, Lexington

66219

GSK Investigational Site, Lenexa

78705

GSK Investigational Site, Austin

85213

GSK Investigational Site, Mesa

92108

GSK Investigational Site, San Diego

97070

GSK Investigational Site, Würzburg

01757

GSK Investigational Site, Milford

Unknown

GSK Investigational Site, Hradec Králové

01744

GSK Investigational Site, Dippoldiswalde

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY