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

An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Pregnant Women and Infants Born to Vaccinated Mothers

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-11
• Primary completion: 2017-07-14
• Completion: 2017-07-14
• First posted: 2017-06-19
• Last updated: 2018-10-15

Locations

12 sites across 3 countries: United States, Finland, Spain

Regulatory

• FDA-regulated drug study