Recent Updates
Recently added Catalysts

Thiomersal free trivalent influenza split vaccine 2003/2004

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 15, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment157

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria