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Staphylococcal investigational vaccine GSK2392103A

Phase 1

Infections, Staphylococcal | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 30, 2017

Staphylococcal investigational vaccine GSK2392103A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Staphylococcal investigational vaccine GSK2392103A clinical trials

Staphylococcal investigational vaccine GSK2392103A · 1 trial · 1 indication

Phase 1 1
NCT01160172A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy AdultsInfections, Staphylococcal
COMPLETED88 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults
Infections, Staphylococcal
NCT0116017288
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Study Endpoints

Primary Endpoints

Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups.
During a 7-day (day 0-6) follow up period after each vaccine dose
Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups.
During a 30-day (day 0-29) follow up period after each vaccine dose
Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups.
From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups.
From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Prior to each vaccine dose

Secondary Endpoints

Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups.
Prior to each vaccine dose, 1, 7 and 29/30 days after each vaccine dose, and 6 and 12 months after the last vaccine dose.
Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups.
At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EPLACEBO_COMPARATOR -
Group FPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Staphylococcal investigational vaccine GSK2392103ABIOLOGICALintramuscular vaccination according to protocol schedule
Staphylococcal investigational vaccine GSK2392105ABIOLOGICALintramuscular vaccination according to protocol schedule
Staphylococcal investigational vaccine GSK2392106ABIOLOGICALintramuscular vaccination according to protocol schedule
Staphylococcal investigational vaccine GSK2392019ABIOLOGICALintramuscular vaccination according to protocol schedule
Saline placeboDRUGintramuscular vaccination according to protocol schedule
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female between 18 and 40 years of age, inclusive, at the time of first vaccination. * Written informed consent obtained from the subject. * Healthy subjects as establi...

Countries:Belgium
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Frequently asked questions about Staphylococcal investigational vaccine GSK2392103A

What is the Staphylococcal investigational vaccine GSK2392103A?

GSK2392103A is an investigational vaccine developed by GSK plc for Staphylococcal infections. It is designed to prevent infections caused by Staphylococcus bacteria and has been studied in healthy adult volunteers. The vaccine is in Phase 1 clinical development and has not been approved for use.

What is the Staphylococcal investigational vaccine GSK2392103A used for?

The Staphylococcal investigational vaccine GSK2392103A is being developed for the prevention of Staphylococcal infections. It is intended to protect against infections caused by Staphylococcus bacteria. The vaccine is still in clinical development and is not yet approved for any indication.

Who is developing the Staphylococcal investigational vaccine GSK2392103A?

The Staphylococcal investigational vaccine GSK2392103A is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is a global pharmaceutical company with a portfolio that includes vaccines and medicines.

What phase is the Staphylococcal investigational vaccine GSK2392103A in?

The Staphylococcal investigational vaccine GSK2392103A is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently active in any trials. The vaccine is investigational and has not been approved by the FDA or any regulatory authority.

What clinical trials is the Staphylococcal investigational vaccine GSK2392103A in?

The Staphylococcal investigational vaccine GSK2392103A has been studied in one completed Phase 1 clinical trial, NCT01160172. This trial evaluated the safety, reactogenicity, and immunogenicity of the vaccine in 88 healthy adults in Belgium. The trial was randomized, double-blind, and placebo-controlled.

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