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Thiomersal-free FluAS25 adjuvanted vaccine

Phase 2

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

Thiomersal-free FluAS25 adjuvanted vaccine target and mechanism

ModalityVaccine

Also known as Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment720

FDA Designations

No designations recorded

Thiomersal-free FluAS25 adjuvanted vaccine clinical trials

Thiomersal-free FluAS25 adjuvanted vaccine · 1 trial · 1 indication

Phase 2 1
NCT00633074Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different FormulationsInfluenza
COMPLETED720 Analytics
PHASE2COMPLETED
Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Days 0 and 21

Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

Secondary Endpoints

Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
Days 0 and 21
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
Day 21
HI Antibody Seroconversion Factors
Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Thiomersal-free FluAS25 adjuvanted vaccine groupEXPERIMENTALSubjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
Thiomersal reduced FluAS25 adjuvanted vaccine groupEXPERIMENTALSubjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine

Interventions

NameTypeDescription
Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)BIOLOGICALIntramuscular administration, 1 dose
Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)BIOLOGICALIntramuscular administration, 1 dose
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites3

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 65 years of age or older at the time of vaccination. * Written informed consent obtained from the subject. * Free of a...

Countries:Estonia
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Frequently asked questions about Thiomersal-free FluAS25 adjuvanted vaccine

What is the Thiomersal-free FluAS25 adjuvanted vaccine?

The Thiomersal-free FluAS25 adjuvanted vaccine is an investigational influenza vaccine developed by GSK plc under the code GSK576389A. It is formulated without thiomersal and includes an adjuvant, and it was studied in older adults aged 65 years and above for the prevention of influenza.

What is the Thiomersal-free FluAS25 adjuvanted vaccine used for?

It is being developed for the prevention of influenza. The vaccine was evaluated in a Phase 2 study in adults aged 65 years and older, a population at higher risk of influenza complications. It is an investigational product and has not been approved for use.

Who makes the Thiomersal-free FluAS25 adjuvanted vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the Thiomersal-free FluAS25 adjuvanted vaccine, also known as GSK576389A. The vaccine was studied under GSK Biologicals, the company's vaccines business.

What phase is the Thiomersal-free FluAS25 adjuvanted vaccine in?

The Thiomersal-free FluAS25 adjuvanted vaccine is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. It is an investigational vaccine and is not approved for any indication.

What clinical trials is the Thiomersal-free FluAS25 adjuvanted vaccine in?

The vaccine was studied in NCT00633074, a Phase 2 non-inferiority trial comparing different formulations of GSK576389A. The trial enrolled 720 participants aged 65 years and older in Estonia, was randomized, double-blind, and controlled, and has been completed.

Is the Thiomersal-free FluAS25 adjuvanted vaccine the same as GSK576389A?

Yes. GSK576389A is the development code for the Thiomersal-free FluAS25 adjuvanted vaccine. Both names refer to the same GSK influenza vaccine candidate, which was evaluated in a completed Phase 2 trial in older adults.