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Thiomersal free trivalent influenza split vaccine 2002/2003

Phase 3

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Aug 8, 2008

Thiomersal free trivalent influenza split vaccine 2002/2003 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Aug 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment239

FDA Designations

No designations recorded

Thiomersal free trivalent influenza split vaccine 2002/2003 clinical trials

Thiomersal free trivalent influenza split vaccine 2002/2003 · 1 trial · 1 indication

Phase 3 1
NCT00731029Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03Influenza
COMPLETED239 Analytics
PHASE3COMPLETED
Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.
On Day 21 (± 2) after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms
Within 4 days after vaccination

Secondary Endpoints

Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms
Within 30 days after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)
During the entire study period.
Investigation of antibody persistence assessed by the criteria of the CHMP.
11, 19, 27 weeks after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALThe subjects in this group will be 18-60 years.
Group BEXPERIMENTALThe subjects in this group will be \> 60 years.
Group CACTIVE_COMPARATORThe subjects in this group will be 18-60 years.
Group DACTIVE_COMPARATORThe subjects in this group will be \> 60 years.

Interventions

NameTypeDescription
Thiomersal free trivalent influenza split vaccine 2002/2003BIOLOGICALSingle dose, intramuscular injection
GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003BIOLOGICALSingle dose, intramuscular injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated agains...

Countries:Germany
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Frequently asked questions about Thiomersal free trivalent influenza split vaccine 2002/2003

What is Thiomersal free trivalent influenza split vaccine 2002/2003 used for?

It is an influenza vaccine developed for the prevention of influenza infection. The formulation is a trivalent split vaccine that does not contain thiomersal, and it was evaluated in healthy adult volunteers aged 18 years and older. It is intended for active immunization against seasonal influenza.

Who makes Thiomersal free trivalent influenza split vaccine 2002/2003?

The vaccine is developed by GSK plc, which trades under the ticker GSK. GSK conducted the clinical development of this thiomersal free trivalent split influenza vaccine formulation for the 2002/2003 season.

What phase is Thiomersal free trivalent influenza split vaccine 2002/2003 in?

Thiomersal free trivalent influenza split vaccine 2002/2003 is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA.

What clinical trials is Thiomersal free trivalent influenza split vaccine 2002/2003 in?

The vaccine was studied in one completed Phase 3 trial, NCT00731029, titled Reacto & Immunogenicity of TF Formulation of Influsplit SSW 2002/03 v/s Std Formulation of Influsplit SSW 2002/03. The trial enrolled 239 participants in Germany, was randomized, double blind, and active controlled, and included healthy volunteers aged 18 years and older.

Is Thiomersal free trivalent influenza split vaccine 2002/2003 the same as Influsplit SSW?

Yes. The thiomersal free trivalent influenza split vaccine 2002/2003 is the thiomersal free formulation of Influsplit SSW, and it was compared against the standard formulation of Influsplit SSW in the Phase 3 trial NCT00731029.