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ACAM2000

Phase 3

Smallpox Vaccine Adverse Reaction | Monoclonal antibody | Other |Emergent BioSolutions Inc.|Last Updated: Mar 18, 2024

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01158157VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIVPHASE3 COMPLETED 25Sep 13, 2010Feb 14, 2012Mar 18, 20241 United States
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Study Endpoints
Primary Endpoints
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration
Days 0 to 90 post-vaccination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
VaccinationOTHERThis study was a single arm study. All eligible subjects received ACAM2000.
Interventions
NameTypeDescription
ACAM2000BIOLOGICALPercutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed written informed consent. * Age 18 - 65 years. * Normal and healthy as determined by medical history, physical exam, vital signs and clinical laboratory tests at screening visit. * Subject must meet all required subject suitability criteria that pertain to normal Source...

Countries:United States
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