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GSK investigational FluNG vaccine GSK2186877A, aged lot

Phase 3

Influenza | Vaccine | 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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Frequently asked questions about GSK investigational FluNG vaccine GSK2186877A, aged lot

What is GSK2186877A used for?

GSK2186877A is an investigational influenza vaccine developed by GSK plc for the prevention of influenza in elderly adults aged 65 years and older. It is designed to induce an immune response against influenza virus in this older population.

Who is developing GSK2186877A?

GSK2186877A is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical program evaluating this investigational influenza vaccine.

What phase is GSK2186877A in?

GSK2186877A has been evaluated in a Phase 3 clinical trial. The completed Phase 3 study, NCT00938392, assessed the immunogenicity and safety of this investigational influenza vaccine in elderly participants. The vaccine remains investigational and is not approved for use.

What clinical trials is GSK2186877A in?

GSK2186877A was studied in a single Phase 3 trial, NCT00938392, titled "Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly." The trial enrolled 726 participants aged 65 years and older in Estonia and Slovakia and has been completed.

How was the GSK2186877A Phase 3 trial designed?

The Phase 3 trial NCT00938392 was a randomized, double-blind, controlled study evaluating the immunogenicity and safety of GSK2186877A in healthy volunteers aged 65 years and older. It enrolled 726 participants across sites in Estonia and Slovakia and has been completed.