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GSK Biologicals' investigational vaccine GSK2590066A

Phase 1

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 10, 2017

GSK Biologicals' investigational vaccine GSK2590066A development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment521

FDA Designations

No designations recorded

GSK Biologicals' investigational vaccine GSK2590066A clinical trials

GSK Biologicals' investigational vaccine GSK2590066A · 1 trial · 1 indication

Phase 1 1
NCT01236040Immunogenicity and Safety of Pandemic Influenza Vaccines in Adults Aged 18 - 49 Years OldInfluenza
COMPLETED521 Analytics
PHASE1COMPLETED
Immunogenicity and Safety of Pandemic Influenza Vaccines in Adults Aged 18 - 49 Years Old
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Immunogenicity with respect to components of the investigational vaccine Day 0
Day 0
Immunogenicity with respect to components of the investigational vaccine Day 42
Day 42
Occurrence of Grade 3 injection site pain
During a 7-day follow-up period (Day 0 to 6) after any vaccination

Secondary Endpoints

Occurrence of each solicited local symptom
During a 7-day follow-up period (Day 0 to 6) after any vaccination
Occurrence of each solicited general symptom
During a 7-day follow-up period (Day 0 to 6) after any vaccination
Occurrence of unsolicited adverse events (AEs)
Within 21 days (Day 0 to 20) after any vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval.
Group BEXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2592984A vaccine at a 21-day interval.
Group CPLACEBO_COMPARATORSubjects will receive 2 doses of a placebo at a 21-day interval.
Group DEXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval.
Group EEXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2340274A vaccine at a 21-day interval.
Group FEXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2340273A vaccine at a 21-day interval.

Interventions

NameTypeDescription
GSK Biologicals' investigational vaccine GSK2590066ABIOLOGICALIntramuscular injection, two doses
GSK Biologicals' investigational vaccine GSK2592984ABIOLOGICALIntramuscular injection, two doses
GSK Biologicals' investigational vaccine GSK2340274ABIOLOGICALIntramuscular injection, two doses
GSK Biologicals' investigational vaccine GSK2340273ABIOLOGICALIntramuscular injection, two doses
PlaceboOTHERIntramuscular injection, two doses
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Male and female adults, 18-49 years of age at the time of the first vaccination. * Satisfactory baseline medical assessment...

Countries:United States
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Frequently asked questions about GSK Biologicals' investigational vaccine GSK2590066A

What is GSK2590066A?

GSK2590066A is an investigational vaccine developed by GSK plc for influenza. It is a Phase 1 candidate studied in healthy adults aged 18 to 49 years. The vaccine is not approved and remains in clinical development.

What is GSK2590066A used for?

GSK2590066A is being studied for the prevention of influenza, specifically pandemic influenza. Its only recorded clinical trial enrolled healthy adult volunteers aged 18 to 49 years in the United States. The vaccine is investigational and has not been approved for use.

Who makes GSK2590066A?

GSK2590066A is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 trial of the vaccine. GSK Biologicals is the name associated with this investigational influenza vaccine program.

What phase is GSK2590066A in?

GSK2590066A is in Phase 1 clinical development. Its single recorded trial, NCT01236040, has been completed. The vaccine is investigational and has not been approved by the FDA or any other regulator based on the available information.

What clinical trials is GSK2590066A in?

GSK2590066A has been studied in one clinical trial, NCT01236040, titled Immunogenicity and Safety of Pandemic Influenza Vaccines in Adults Aged 18 - 49 Years Old. The Phase 1 trial was completed, enrolled 521 participants, was randomized, double blind, and placebo controlled, and took place in the United States.

Is GSK2590066A a vaccine?

Yes, GSK2590066A is a vaccine candidate being developed for influenza. It was evaluated in a Phase 1 trial that measured immunogenicity and safety in healthy adults aged 18 to 49 years. The trial was randomized, double blind, and placebo controlled, with 521 participants enrolled.