Recent Updates
Recently added Catalysts

Thiomersal free trivalent influenza split vaccine 2002/2003

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Aug 8, 2008

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment239

FDA Designations

No designations recorded

Clinical trial landscape

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
Influenza
NCT00731029239
Unlock 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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
Unlock Competitive Intelligence