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Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines

NCT01905215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-05-30

No results posted yet for this study

Summary

The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.

Conditions

  • Infections, Respiratory Syncytial Virus

Interventions

BIOLOGICAL

RSV vaccine GSK3003892A (formulation 1)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003893A (formulation 2)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003895A (formulation 3)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003896A (formulation 4)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003898A (formulation 5)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

BIOLOGICAL

RSV vaccine GSK3003899A (formulation 6)

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

DRUG

Placebo comparator

Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

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
44 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-22
Primary Completion
2014-04-09
Completion
2015-03-16

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT01905215 on ClinicalTrials.gov