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influenza vaccine Fluarix, Adjuvanted Fluarix

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 8, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

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Clinical trial landscape

influenza vaccine Fluarix, Adjuvanted Fluarix · 1 trial · 1 indication

Phase 1 1
NCT00318058Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly PopulationInfluenza
COMPLETED84 Analytics
PHASE1COMPLETED
Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage, intensity and relationship to vaccination of local (at the injection site) and general signs and symptoms during a 21 day follow-up period after vaccination
Occurrence of serious adverse events during the entire study.

Secondary Endpoints

evaluation of the humoral immune response (haemagglutinin antibody titre) and cellular mediated immune response
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
influenza vaccine Fluarix, Adjuvanted FluarixBIOLOGICAL -
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * A male or female aged over 65 years at the time of the revaccination; who previously received the adjuvanted candidate vaccine or Fluarix during a clinical study organized during the preceeding year Exclusion Criteria: * Use of any investigational or non-registered product (...

Countries:Belgium
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Frequently asked questions about influenza vaccine Fluarix, Adjuvanted Fluarix

What is influenza vaccine Fluarix, Adjuvanted Fluarix used for?

Influenza vaccine Fluarix, Adjuvanted Fluarix is used to prevent influenza disease. It is being studied in the elderly population, specifically in adults aged 65 years and older, to assess its safety as a candidate vaccine against influenza.

Who makes influenza vaccine Fluarix, Adjuvanted Fluarix?

Influenza vaccine Fluarix, Adjuvanted Fluarix is developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this vaccine candidate for the prevention of influenza.

What phase is influenza vaccine Fluarix, Adjuvanted Fluarix in?

Influenza vaccine Fluarix, Adjuvanted Fluarix is in Phase 1 clinical development. It is an investigational vaccine candidate and is not yet approved for use. One Phase 1 trial has been completed to evaluate its safety.

What clinical trials is influenza vaccine Fluarix, Adjuvanted Fluarix in?

Influenza vaccine Fluarix, Adjuvanted Fluarix has one completed clinical trial, NCT00318058, titled 'Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population.' This Phase 1 study enrolled 84 healthy volunteers aged 65 years and older in Belgium.

Is influenza vaccine Fluarix, Adjuvanted Fluarix the same as Fluarix?

Influenza vaccine Fluarix, Adjuvanted Fluarix is an adjuvanted version of the influenza vaccine Fluarix. The adjuvanted formulation is being studied specifically for use in the elderly population to potentially enhance the immune response compared to the standard vaccine.