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Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV

Respiratory Syncytial Virus Infections Clinical Trial

Official title:
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 Infants

Clinical Trial Summary

The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infections
Clinical Trial Details
NCT number NCT03636906
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 8, 2019
Completion date July 22, 2021
View Details
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