Recent Updates
Recently added Catalysts

Split virion, inactivated Influenza vaccine

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 17, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment130
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00718146Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 FormulationPHASE2 COMPLETED 130Jun 1, 2008Sep 1, 2008Jan 17, 20142 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).
21 days post vaccination
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALAge 16 to 60 years
Group 2EXPERIMENTALAge over 60 years
Interventions
NameTypeDescription
Split virion, inactivated Influenza vaccineBIOLOGICAL0.5 mL, Intramuscular (IM)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria : * Aged 18 to 60 years or 61 years and older on the day of inclusion * Provision of a signed informed consent * Able to attend all scheduled visits and comply with all trial procedures * For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method ...

Countries:United Kingdom
Unlock Eligibility Criteria