NCT02491463

A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.

Conditions

• Respiratory Synctial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	GSK3389245A_LD GROUP	2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
BIOLOGICAL	GSK3389245A_HD GROUP	2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
BIOLOGICAL	Bexsero	2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
DRUG	Placebo	2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Timeline

• Start date: 2015-07-23
• Primary completion: 2016-04-08
• Completion: 2017-01-26
• First posted: 2015-07-08
• Last updated: 2018-08-20
• Results posted: 2018-08-20

Locations

1 site across 1 country: United Kingdom