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INO-3401 + EP

Phase 1

Healthy | Monoclonal antibody | Other |Inovio Pharmaceuticals, Inc.|Last Updated: Sep 13, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01403155A Follow-On Study With an H5 Influenza Vaccine for Subjects Who Participated in Study FLU-001PHASE1 COMPLETED 22May 1, 2011Aug 1, 2012Sep 13, 20172 United States
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Study Endpoints
Primary Endpoints
Safety
Day 0 through Month 9

Frequency and severity of local and systemic reactogenicity, signs and symptoms, adverse events and serious adverse events.

Secondary Endpoints
Humoral and cellular immune responses
Day 0 through Month 9
Tolerability
Day 0 and Month 3
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
All subjectsEXPERIMENTALAll subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine) at Day o and Month 3.
Interventions
NameTypeDescription
INO-3401 + EPBIOLOGICALAll subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine)at Day 0 and Month 3.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI); * Enrollment in and received at least one vaccination in study FLU-001; * Adults of either ...

Countries:United States
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