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GSK Biologicals' influenza vaccine GSK2186877A

Phase 3

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jul 31, 2018

GSK Biologicals' influenza vaccine GSK2186877A development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Oct 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment192

FDA Designations

No designations recorded

GSK Biologicals' influenza vaccine GSK2186877A clinical trials

GSK Biologicals' influenza vaccine GSK2186877A · 1 trial · 1 indication

Phase 3 1
NCT00765076Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or OlderInfluenza
COMPLETED192 Analytics
PHASE3COMPLETED
Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers
Day 21

The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)

Secondary Endpoints

The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers
At Day 0, 21, 42 and 180
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker
At Day 0, 21, 42 and 180
Haemagglutinin Inhibition (HI) Antibody Titers
At Day 0, 21, 42 and 180
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
New generation influenza vaccine GSK2186877A GroupEXPERIMENTALSubjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
Fluarix elderly GroupACTIVE_COMPARATORSubjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0
Fluarix young GroupACTIVE_COMPARATORSubjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0

Interventions

NameTypeDescription
GSK Biologicals' influenza vaccine GSK2186877ABIOLOGICALOne intramuscular injection at Day 0
GSK Biologicals' FluarixBIOLOGICALOne intramuscular injection at Day 0
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: All subjects must satisfy the following criteria at study entry: * 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 subje...

Countries:United StatesSpain
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Frequently asked questions about GSK Biologicals' influenza vaccine GSK2186877A

What is GSK Biologicals' influenza vaccine GSK2186877A?

GSK Biologicals' influenza vaccine GSK2186877A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is a Phase 3 candidate in the infectious disease therapeutic area. The vaccine has been studied in a completed Phase 3 trial in adults aged 65 years or older.

What is GSK2186877A used for?

GSK2186877A is being developed for the prevention of influenza. It is intended to protect against influenza infection, with clinical evaluation focused on people aged 65 years or older. The vaccine remains investigational and has not been approved for use.

Who makes GSK2186877A?

GSK2186877A is made by GSK plc, which trades under the ticker GSK. The vaccine is developed by GSK Biologicals, the company's vaccines division. GSK plc is the sponsor responsible for the clinical development of this influenza vaccine candidate.

What phase is GSK2186877A in?

GSK2186877A is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA or any regulatory authority for the prevention of influenza.

What clinical trials is GSK2186877A in?

GSK2186877A has been evaluated in one completed Phase 3 trial, NCT00765076, titled a clinical study of the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older. The trial enrolled 192 participants across the United States and Spain.

How was the GSK2186877A Phase 3 trial designed?

The Phase 3 trial NCT00765076 was a randomized, double-blind, active-controlled study of GSK2186877A in people aged 65 years or older. It enrolled 192 participants in the United States and Spain and has been completed. The study assessed immunogenicity in healthy volunteers.