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GSK Biologicals' influenza vaccine GSK2186877A

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jul 31, 2018

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

Clinical trial landscape

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 GSK2186877A used for?

GSK2186877A is an investigational influenza vaccine developed by GSK Biologicals. It is being studied for the prevention of influenza in adults, with a completed Phase 3 clinical trial that enrolled 192 participants aged 65 years or older.

Who makes GSK2186877A?

GSK2186877A is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is being developed by GSK Biologicals, the vaccines division of GSK.

What phase is GSK2186877A in?

GSK2186877A is in Phase 3 clinical development. A Phase 3 trial, NCT00765076, has been completed. The vaccine is investigational and has not been approved for use; it remains in clinical development.

What clinical trials is GSK2186877A in?

GSK2186877A has one completed Phase 3 clinical trial, NCT00765076, titled 'Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older.' The trial was conducted in the United States and Spain, enrolled 192 participants, and was randomized, double-blind, and active-controlled.

How does GSK2186877A work?

GSK2186877A is a vaccine designed to stimulate the immune system to produce a protective response against influenza. As a vaccine, it works by exposing the immune system to influenza antigens, prompting the body to develop immunity against the virus.