Clinical Trial

Respiratory Syncytial Virus Testing

Study Description

Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants

The purpose of this study is to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.

Location

Locations Selected Location

Methods

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

Biological - RSVPreF3 formulation 2

One single dose of RSVPreF3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Biological - RSVPreF3 formulation 3

One single dose of RSVPreF3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Drug - Placebo

One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Additional Information

Official Study Title

A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers

Clinical Trial ID

NCT04126213

ParticipAid ID

e0Rxvb