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