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GSK Biologicals' quadrivalent influenza vaccine

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 8, 2018

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

Clinical trial landscape

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 used for?

GSK Biologicals' quadrivalent influenza vaccine is an investigational vaccine being developed for the prevention of influenza. It is designed to provide immunity against four influenza virus strains. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

Who makes GSK Biologicals' quadrivalent influenza vaccine?

GSK Biologicals' quadrivalent influenza vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and is currently in Phase 1 clinical development.

What phase is GSK Biologicals' quadrivalent influenza vaccine in?

GSK Biologicals' quadrivalent influenza vaccine is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory agencies. The vaccine is being studied in a completed Phase 1 trial to evaluate its immunogenicity and safety in adults.

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

GSK Biologicals' quadrivalent influenza vaccine has been studied in one completed Phase 1 clinical trial, identified as NCT00714285. This trial, titled 'Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults,' enrolled 420 healthy adult participants aged 18 years and older in Czechia.

Is GSK Biologicals' quadrivalent influenza vaccine a monoclonal antibody?

No, GSK Biologicals' quadrivalent influenza vaccine is not a monoclonal antibody. Although the modality is listed as a monoclonal antibody in some databases, the product is described as a quadrivalent influenza vaccine, which is a vaccine designed to elicit an immune response against four influenza strains, not a monoclonal antibody therapeutic.