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Influenza vaccine GSK2340272A

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Aug 6, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment336

FDA Designations

No designations recorded

Clinical trial landscape

Influenza vaccine GSK2340272A · 1 trial · 1 indication

Phase 3 1
NCT00979407Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)Influenza
COMPLETED336 Analytics
PHASE3COMPLETED
Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
At Day 21

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.

Secondary Endpoints

Number of Seroconverted (SCR) Subjects for HI Antibodies
At Days 21 and 42
Number of SCR Subjects for HI Antibodies
At Days 182 and 364
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
At Days 0 and 42
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
GSK2340272A GROUPEXPERIMENTALHealthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
GSK2340274A GROUPEXPERIMENTALHealthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Interventions

NameTypeDescription
Influenza vaccine GSK2340272ABIOLOGICALTwo intramuscular injections at Day 0 and Day 21
Influenza vaccine GSK2340274ABIOLOGICALTwo intramuscular injections at Day 0 and Day 21
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: * Male or female aged 18 to 60 years inclusive, at the time of the first vaccination. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Satisfactory baseline medic...

Countries:FranceGermany
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Frequently asked questions about Influenza vaccine GSK2340272A

What is Influenza vaccine GSK2340272A used for?

Influenza vaccine GSK2340272A is an investigational vaccine being studied for the prevention of influenza, commonly known as the flu. It is designed to elicit an immune response against the H1N1 influenza strain. The vaccine is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.

What does Influenza vaccine GSK2340272A target?

Influenza vaccine GSK2340272A targets the H1N1 influenza virus strain. As a vaccine, it works by presenting components of the virus to the immune system to stimulate the production of antibodies, which can provide protection against subsequent infection with the H1N1 strain.

Who makes Influenza vaccine GSK2340272A?

Influenza vaccine GSK2340272A is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK on major stock exchanges. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy.

What phase is Influenza vaccine GSK2340272A in?

Influenza vaccine GSK2340272A is in Phase 3 clinical development. This phase involves large-scale studies to confirm the vaccine's effectiveness and monitor for adverse reactions in a larger population. The vaccine is still investigational and has not received regulatory approval for public use.

What clinical trials is Influenza vaccine GSK2340272A in?

Influenza vaccine GSK2340272A has been studied in one completed Phase 3 clinical trial, identified as NCT00979407. This randomized, double-blind, controlled study enrolled 336 healthy adult participants in France and Germany to evaluate the immunological equivalence of the vaccine against H1N1 influenza.

Is Influenza vaccine GSK2340272A the same as other influenza vaccines?

Influenza vaccine GSK2340272A is a specific investigational vaccine developed by GSK plc. It is not identified as being the same as other marketed influenza vaccines. The vaccine is being studied for its ability to provide immunity against the H1N1 strain, but it is not yet approved for use.