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4 adjuvanted pandemic influenza candidate vaccines

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 10, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00309634Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged Between 18 and 60 YearsPHASE1 COMPLETED 400Mar 27, 2006Oct 28, 2006May 10, 20171 Belgium
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Study Endpoints
Primary Endpoints
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers.
To evaluate the safety and reactogenicity of the study vaccines in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events"
Secondary Endpoints
To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
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Study Design & Arms
AllocationRANDOMIZED
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
4 adjuvanted pandemic influenza candidate vaccinesBIOLOGICAL -
4 non-adjuvanted pandemic influenza candidate vaccinesBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * A male or female between, and including, 18 and 60 years of age at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing poten...

Countries:Belgium
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