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Influenza vaccine GSK2340272A

Phase 3

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Aug 6, 2018

Influenza vaccine GSK2340272A development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Sep 2009

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

Influenza vaccine GSK2340272A clinical trials

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?

Influenza vaccine GSK2340272A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is a Phase 3 candidate that has been studied in a completed clinical trial evaluating immunological equivalence between two investigational influenza vaccines in adults.

What is Influenza vaccine GSK2340272A used for?

Influenza vaccine GSK2340272A is being developed for the prevention of influenza, an infectious disease. The vaccine is intended for use in adults, as studied in a Phase 3 trial that enrolled 336 participants aged 18 years and older.

Who makes Influenza vaccine GSK2340272A?

Influenza vaccine GSK2340272A is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this investigational influenza vaccine.

What phase is Influenza vaccine GSK2340272A in?

Influenza vaccine GSK2340272A is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 trial for this vaccine has been completed.

What clinical trials is Influenza vaccine GSK2340272A in?

Influenza vaccine GSK2340272A has been studied in one Phase 3 clinical trial, NCT00979407, titled "Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)." The trial was completed, enrolled 336 participants, and was conducted in France and Germany.