NCT04138056View on ClinicalTrials.gov

A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women

PHASE2CompletedINTERVENTIONAL
Enrollment

509

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

February 25, 2020

Study Completion Date

November 22, 2021

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

RSVPreF3 formulation 3

One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.

BIOLOGICAL

RSVPreF3 formulation 2

One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.

BIOLOGICAL

Boostrix-ex-US

One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.

BIOLOGICAL

Boostrix-US

One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.

DRUG

Placebo

One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.

Trial Locations (8)

3000

GSK Investigational Site, Leuven

9000

GSK Investigational Site, Ghent

14609

GSK Investigational Site, Rochester

33143

GSK Investigational Site, Miami

66219

GSK Investigational Site, Lenexa

98105

GSK Investigational Site, Seattle

B2N 1L2

GSK Investigational Site, Truro

N5W 6A2

GSK Investigational Site, London

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04138056 - A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women | Biotech Hunter | Biotech Hunter