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influenza vaccine Fluarix, Adjuvanted Fluarix

Phase 1

Influenza | Vaccine | 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

No designations recorded

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 the adjuvanted Fluarix vaccine?

Adjuvanted Fluarix is an investigational influenza vaccine developed by GSK plc. It is an adjuvanted candidate vaccine designed to prevent influenza disease, and it has been studied specifically in an elderly population aged 65 years and older. It remains in clinical development rather than being an approved product.

What is the adjuvanted Fluarix vaccine used for?

It is being studied to prevent influenza disease, with the clinical program focused on the elderly population aged 65 years and older. The only recorded trial enrolled healthy volunteers in this age group. It is an investigational candidate and is not described as an approved product for any use.

Who makes the adjuvanted Fluarix vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the adjuvanted Fluarix influenza vaccine candidate. GSK sponsored the clinical work evaluating this adjuvanted formulation in older adults.

What phase is the adjuvanted Fluarix vaccine in?

The adjuvanted Fluarix vaccine is in Phase 1 development. One Phase 1 trial has been recorded for this candidate, and that trial is completed, with no active trials currently listed. It is an investigational vaccine and is not described as FDA approved.

What clinical trial has been run for the adjuvanted Fluarix vaccine?

One trial is recorded: NCT00318058, titled Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population. It was a completed Phase 1 study in Belgium with 84 enrolled participants aged 65 years and older, and it was an uncontrolled study.

Is the adjuvanted Fluarix vaccine the same as Fluarix?

Adjuvanted Fluarix refers to an adjuvanted formulation of the Fluarix influenza vaccine, developed by GSK plc. The adjuvanted version is an investigational candidate studied in a Phase 1 trial in older adults, while the program described here covers that adjuvanted formulation specifically.