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Staphylococcal investigational vaccine GSK2392103A

Phase 1

Infections, Staphylococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 30, 2017

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

Clinical trial landscape

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 GSK2392103A used for?

GSK2392103A is an investigational staphylococcal vaccine being studied for the prevention of staphylococcal infections. It is currently in Phase 1 clinical development and has not been approved for use. The vaccine is designed to be given to healthy adults to evaluate its safety and ability to generate an immune response.

Who makes GSK2392103A?

GSK2392103A is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adult volunteers.

What phase is GSK2392103A in?

GSK2392103A is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under evaluation for its safety and immunogenicity profile.

What clinical trials is GSK2392103A in?

GSK2392103A has been studied in one completed Phase 1 clinical trial, identified as NCT01160172. This randomized, double-blind, placebo-controlled study enrolled 88 healthy adults in Belgium to evaluate the safety, reactogenicity, and immunogenicity of the investigational staphylococcal vaccine.

Is GSK2392103A a monoclonal antibody?

GSK2392103A is classified as a monoclonal antibody modality, though it is being developed as an investigational vaccine against staphylococcal infections. The Phase 1 trial assessed its safety and immunogenicity in healthy adults, with the study now completed.