Recent Updates
Recently added Catalysts

Monovalent subvirion H5N1 influenza vaccine

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 17, 2012

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
RandomizedPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment375
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00664417Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted VaccinePHASE1 COMPLETED 375Apr 1, 2008Aug 1, 2010Apr 17, 20126 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To provide information concerning the safety after primary administration of A/H1N1 vaccine
6 months post-vaccination
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5EXPERIMENTAL -
6EXPERIMENTAL -
7ACTIVE_COMPARATOR -
8ACTIVE_COMPARATOR -
9PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Monovalent subvirion H5N1 influenza vaccineBIOLOGICAL0.5 mL, IM, 2 injections, Formulation 1
Physiological salineBIOLOGICAL0.5 mL, IM, 2 injections
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria : * Healthy adult aged 18 to 40 years on the day of inclusion. * Provides signed informed consent prior to study procedures. * 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 ef...

Countries:United States
Unlock Eligibility Criteria