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Staphylococcal investigational vaccine GSK2392103A

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01160172A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy AdultsPHASE1 COMPLETED 88 — — Jul 19, 2010Aug 23, 2012May 30, 20171 Belgium
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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 — 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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