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GSK Biologicals' investigational vaccine GSK2590066A

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 10, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment521

FDA Designations

No designations recorded

Clinical trial landscape

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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