Clinical Trial

Vaccine Against Respiratory Syncytial Virus

Study Description

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 to Healthy Non-Pregnant Women.

The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix [Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine] formulations (US and ex-US) will be evaluated.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - RSVPreF3 formulation 3

One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left 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.

Procedure - 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.

Additional Information

Official Study Title

A Phase II Study of 2 Dose Levels of an Investigational RSV Maternal Vaccine, Given Alone or With Boostrix, to Healthy Non-pregnant Women

Clinical Trial ID

NCT04138056

ParticipAid ID

dG6j0b