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Thiomersal free trivalent influenza split vaccine 2003/2004

Phase 3

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Sep 15, 2016

Thiomersal free trivalent influenza split vaccine 2003/2004 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 Enrollment157

FDA Designations

No designations recorded

Thiomersal free trivalent influenza split vaccine 2003/2004 clinical trials

Thiomersal free trivalent influenza split vaccine 2003/2004 · 1 trial · 1 indication

Phase 3 1
NCT00731393Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04Influenza
COMPLETED157 Analytics
PHASE3COMPLETED
Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.
On Day 21 (+- 2) after the second vaccination

Secondary Endpoints

Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Within 4 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Within 30 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
Throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALSubjects aged between 6 months and 3 years.
Group BEXPERIMENTALSubjects aged 3 to 6 years.
Group CACTIVE_COMPARATORSubjects aged between 6 months and 3 years.
Group DACTIVE_COMPARATORSubjects aged 3 to 6 years.

Interventions

NameTypeDescription
Thiomersal free trivalent influenza split vaccine 2003/2004BIOLOGICAL2 doses, intramuscular injection
GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004BIOLOGICAL2 doses, intramuscular injection
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Eligibility Criteria

Age Range6 Months to 6 Years
SexALL
Healthy VolunteersYes
Study Sites13

Inclusion Criteria: * Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol * Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old. * All children included in the study must never have...

Countries:Germany
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Frequently asked questions about Thiomersal free trivalent influenza split vaccine 2003/2004

What is Thiomersal free trivalent influenza split vaccine 2003/2004?

Thiomersal free trivalent influenza split vaccine 2003/2004 is an investigational influenza vaccine developed by GSK plc. It is a split-virus vaccine formulated without thiomersal, a mercury-based preservative. The product was designed for the 2003/2004 northern hemisphere influenza season and studied in a Phase 3 clinical trial in Germany.

What is Thiomersal free trivalent influenza split vaccine 2003/2004 used for?

It is used for the prevention of influenza. The vaccine targets seasonal influenza and was evaluated in healthy volunteers, including children from 6 months of age, in a Phase 3 study conducted in Germany. It is a trivalent split vaccine, meaning it contains three influenza virus strains.

Who makes Thiomersal free trivalent influenza split vaccine 2003/2004?

GSK plc, which trades under the ticker GSK, is the developer of Thiomersal free trivalent influenza split vaccine 2003/2004. The vaccine was studied in a Phase 3 trial in Germany comparing it with standard thiomersal-containing formulations, Influsplit SSW and Fluarix, for the 2003/2004 season.

What phase is Thiomersal free trivalent influenza split vaccine 2003/2004 in?

Thiomersal free trivalent influenza split vaccine 2003/2004 is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The study was randomized, double blind, and active controlled, enrolling 157 participants.

What clinical trials is Thiomersal free trivalent influenza split vaccine 2003/2004 in?

Thiomersal free trivalent influenza split vaccine 2003/2004 was studied in one completed Phase 3 trial, NCT00731393. The trial assessed immunogenicity and reactogenicity of the thiomersal-free trivalent influenza split vaccine 2003/04 compared with standard formulations Influsplit SSW and Fluarix 2003/04. It enrolled 157 healthy volunteers in Germany, including participants from 6 months of age.