NCT02298179View on ClinicalTrials.gov

A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

December 19, 2014

Primary Completion Date

March 27, 2017

Study Completion Date

March 27, 2017

Conditions
Respiratory Syncytial Virus (RSV)
Interventions
BIOLOGICAL

RSV F subunit 45 μg No adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

RSV F subunit 45 μg Aluminum hydroxide adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

RSV F subunit 45 μg MF59 adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

RSV F subunit 90 μg No adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

RSV F subunit 90 μg Aluminum hydroxide adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

RSV F subunit 90 μg MF59 adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

RSV F subunit 135 μg No adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

RSV F subunit 135 μg Aluminum hydroxide adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

RSV F subunit 135 μg MF59 adjuvant

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

DRUG

Placebo

2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

Trial Locations (1)

9000

GSK Investigational Site, Ghent

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02298179 - A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults | Biotech Hunter | Biotech Hunter