NCT01905215View on ClinicalTrials.gov

Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines

PHASE1CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

July 22, 2013

Primary Completion Date

April 9, 2014

Study Completion Date

March 16, 2015

Conditions
Infections, Respiratory Syncytial Virus
Interventions
BIOLOGICAL

RSV vaccine GSK3003892A (formulation 1)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003893A (formulation 2)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003895A (formulation 3)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003896A (formulation 4)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003898A (formulation 5)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003899A (formulation 6)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

DRUG

Placebo comparator

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

Trial Locations (3)

B3K 6R8

GSK Investigational Site, Halifax

L6T 0G1

GSK Investigational Site, Brampton

M9W 4L6

GSK Investigational Site, Toronto

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01905215 - Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines | Biotech Hunter | Biotech Hunter