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GSK investigational FluNG vaccine GSK2186877A, aged lot

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Aug 20, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment726

FDA Designations

No designations recorded

Clinical trial landscape

GSK investigational FluNG vaccine GSK2186877A, aged lot · 1 trial · 1 indication

Phase 3 1
NCT00938392Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the ElderlyInfluenza
COMPLETED726 Analytics
PHASE3COMPLETED
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
At Days 0 and 21

Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.

Secondary Endpoints

Number of Subjects Seropositive Against the 3 Vaccine Strains
At Days 0 and 21
Number of Subjects Seroconverted for the 3 Vaccine Strains
At Day 21
Seroconversion Factor for the 3 Vaccine Strains
At Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
FluNG Aged GroupEXPERIMENTALSubjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
FluNG Fresh GroupEXPERIMENTALSubjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).

Interventions

NameTypeDescription
GSK investigational FluNG vaccine GSK2186877A, aged lotBIOLOGICALSingle dose, intramuscular injection
GSK investigational FluNG vaccine GSK2186877A, fresh lotBIOLOGICALSingle dose, intramuscular injection
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse. * A man or woma...

Countries:EstoniaSlovakia
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