CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 73 enrolled
Drug / intervention
GSK3389245A_LD GROUP +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02491463
NCT02491463Phase 1Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Jul 8, 2015·Updated Aug 20, 2018

In Brief

A Phase 1 clinical trial evaluating GSK3389245A_LD GROUP, GSK3389245A_HD GROUP, and 2 other interventions for Respiratory Synctial Virus Infections. Completed, enrolled 73 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Synctial Virus Infections
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 8, 2015
Enrollment StartJul 23, 2015
Primary CompletionApr 8, 2016
Study CompletionJan 26, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.0 years ago

Interventions

GSK3389245A_LD GROUPbiological

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

GSK3389245A_HD GROUPbiological

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Bexserobiological

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Placebodrug

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm