NCT03191383View on ClinicalTrials.gov

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 11, 2017

Primary Completion Date

July 14, 2017

Study Completion Date

July 14, 2017

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

RSV vaccine (GSK3003891A) formulation 1

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

BIOLOGICAL

RSV vaccine (GSK3003891A) formulation 2

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

BIOLOGICAL

RSV vaccine (GSK3003891A) formulation 3

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

DRUG

Placebo (Formulation buffer S9b)

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

Trial Locations (12)

13210

GSK Investigational Site, Syracuse

15705

GSK Investigational Site, Santiago

15706

GSK Investigational Site, Santiago de Compostela

28023

GSK Investigational Site, Aravaca

28040

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Majadahonda (Madrid)

41014

GSK Investigational Site, Seville

60100

GSK Investigational Site, Seinäjoki

67114

GSK Investigational Site, Newton

90220

GSK Investigational Site, Oulu

98926

GSK Investigational Site, Ellensburg

09006

GSK Investigational Site, Burgos

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03191383 - A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers | Biotech Hunter | Biotech Hunter