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Influenza investigational vaccine GSK2340274A

Phase 2

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jan 16, 2019

Influenza investigational vaccine GSK2340274A development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Influenza investigational vaccine GSK2340274A clinical trials

Influenza investigational vaccine GSK2340274A · 1 trial · 1 indication

Phase 2 1
NCT00989612Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)Influenza
COMPLETED100 Analytics
PHASE2COMPLETED
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
At Day 0

Titers are presented as geometric mean titers (GMTs).

Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
At Day 0

A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.

Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
At Day 21

A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
At Day 21

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.

Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
At Day 0

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
At Day 21

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.

Secondary Endpoints

Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
At Days 0, 21, 42 and 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
At Days 21, 42 and 182
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
GSK2340274A GROUPEXPERIMENTALHealthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Interventions

NameTypeDescription
Influenza investigational vaccine GSK2340274ABIOLOGICALTwo intramuscular injections on Day 0 and Day 21, respectively
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Eligibility Criteria

Age Range20 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive. * Good general health as assessed by medical history and physical examination * Subjects who the investigator believes that they can and will comply with the requirements of the ...

Countries:Japan
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Frequently asked questions about Influenza investigational vaccine GSK2340274A

What is the influenza investigational vaccine GSK2340274A?

GSK2340274A is an investigational influenza vaccine developed by GSK plc. It is a Phase 2 vaccine candidate studied for the prevention of influenza, including H1N1 influenza. It has been evaluated in a single completed clinical trial conducted in Japan.

What is GSK2340274A used for?

GSK2340274A is being studied for use against influenza. Its completed Phase 2 trial evaluated immunogenicity and safety of the investigational influenza vaccine in the context of H1N1. It is not an approved product and remains an investigational vaccine candidate.

Who makes GSK2340274A?

GSK2340274A is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 2 study of the vaccine candidate in Japan.

What phase is GSK2340274A in?

GSK2340274A is in Phase 2 development. Its only listed trial, NCT00989612, is a completed Phase 2 study. The vaccine is investigational and has not been established as an approved product.

What clinical trials is GSK2340274A in?

GSK2340274A has been studied in one clinical trial, NCT00989612, titled Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1). That Phase 2 trial is completed, enrolled 100 participants, was conducted in Japan, and included healthy volunteers aged 20 years and older.

Was the GSK2340274A trial controlled or blinded?

The Phase 2 trial of GSK2340274A, NCT00989612, was an uncontrolled study and was not double blind. It enrolled 100 participants in Japan and assessed immunogenicity and safety of the investigational H1N1 influenza vaccine in healthy volunteers.