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GSK Biologicals' quadrivalent influenza vaccine

Phase 1

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jun 8, 2018

GSK Biologicals' quadrivalent influenza vaccine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

GSK Biologicals' quadrivalent influenza vaccine clinical trials

GSK Biologicals' quadrivalent influenza vaccine · 1 trial · 1 indication

Phase 1 1
NCT00714285Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.Influenza
COMPLETED420 Analytics
PHASE1COMPLETED
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
At Day 0 and Day 21

Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.

Secondary Endpoints

Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
At Day 21
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Day 21
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
At Days 0 and 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Quadrivalent influenza vaccine GSK 2115160A Group 1EXPERIMENTALSubjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Quadrivalent influenza vaccine GSK 2115160A Group 2EXPERIMENTALSubjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Trivalent influenza vaccine GSK 2115160A Group 1ACTIVE_COMPARATORSubjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Trivalent influenza vaccine GSK 2115160A Group 2ACTIVE_COMPARATORSubjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Interventions

NameTypeDescription
GSK Biologicals' quadrivalent influenza vaccineBIOLOGICALSingle intramuscular dose on Day 0.
GSK Biologicals' trivalent influenza vaccineBIOLOGICALSingle intramuscular dose on Day 0.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and inclu...

Countries:Czechia
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Frequently asked questions about GSK Biologicals' quadrivalent influenza vaccine

What is GSK Biologicals' quadrivalent influenza vaccine?

GSK Biologicals' quadrivalent influenza vaccine is an investigational vaccine developed by GSK plc for the prevention of influenza. It is designed to protect against influenza virus infection and is in Phase 1 clinical development. The vaccine has been studied in one completed Phase 1 trial.

What is GSK Biologicals' quadrivalent influenza vaccine used for?

GSK Biologicals' quadrivalent influenza vaccine is being developed for the prevention of influenza. It is intended for use in adults, with the completed Phase 1 trial enrolling healthy volunteers aged 18 years and older. The vaccine remains investigational and is not approved for use.

Who makes GSK Biologicals' quadrivalent influenza vaccine?

GSK Biologicals' quadrivalent influenza vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine division of GSK plc. The company is responsible for the clinical development of this influenza vaccine candidate.

What phase is GSK Biologicals' quadrivalent influenza vaccine in?

GSK Biologicals' quadrivalent influenza vaccine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The vaccine is investigational and has not been approved by the FDA or any regulatory authority.

What clinical trials is GSK Biologicals' quadrivalent influenza vaccine in?

GSK Biologicals' quadrivalent influenza vaccine has been studied in one completed Phase 1 trial, NCT00714285, titled "Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults." The trial enrolled 420 adults in Czechia, was randomized and active-controlled, and included healthy volunteers aged 18 years and older.