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Thiomersal-free FluAS25 adjuvanted vaccine

Phase 2

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

Target and mechanism

ModalityMonoclonal antibody

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

Clinical trial landscape

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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