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

NCT02491463 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2018-08-20

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-23
Primary Completion
2016-04-08
Completion
2017-01-26

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491463 on ClinicalTrials.gov