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GSK1562902A

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Aug 20, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment320

FDA Designations

No designations recorded

Clinical trial landscape

GSK1562902A · 1 trial · 1 indication

Phase 3 1
NCT00812981A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.Influenza
COMPLETED320 Analytics
PHASE3COMPLETED
A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies
At Day 42

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.

Secondary Endpoints

Titers for Serum H5N1 HI Antibodies
At Day 0 and Day 180
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value
At Days 0, 42 and 180
Number of Seroconverted Subjects Against Two Strains of Influenza Disease
At Day 42 and Day 180
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1562902A NP GROUPEXPERIMENTALHealthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1562902A CP GROUPEXPERIMENTALHealthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.

Interventions

NameTypeDescription
GSK1562902ABIOLOGICALnew-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm
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Eligibility Criteria

Age Range18 Years to 59 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female aged 18 to 60 years at the time of the first vaccination. * Written informed consent obtained from the subject. * Good...

Countries:Taiwan
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Frequently asked questions about GSK1562902A

What is GSK1562902A used for?

GSK1562902A is a monoclonal antibody being developed by GSK plc for influenza. It is an investigational drug studied in a Phase 3 clinical trial for the prevention or treatment of influenza. The drug has not been approved by regulatory authorities and remains in clinical development.

What does GSK1562902A target?

GSK1562902A is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for influenza, an infectious disease, but the exact antigen or protein it binds to is not specified.

Who makes GSK1562902A?

GSK1562902A is developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research on this monoclonal antibody for influenza.

What phase is GSK1562902A in?

GSK1562902A is in Phase 3 clinical development for influenza. It is an investigational drug, meaning it has not been approved by regulatory agencies. The Phase 3 trial has been completed, but the drug is not yet available for commercial use.

What clinical trials is GSK1562902A in?

GSK1562902A has one completed Phase 3 clinical trial with the identifier NCT00812981. This study, titled 'A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine,' enrolled 320 participants in Taiwan. The trial was randomized, double-blind, and controlled, involving healthy volunteers aged 18 years and older.