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Pertagen aP + Td-pur

Phase 2

Pertussis | Monoclonal antibody | Other |Co-Diagnostics, Inc.|Last Updated: May 8, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02946190The PertADO Geneva TrialPHASE2 COMPLETED 60 — — Oct 27, 2016Mar 9, 2017May 8, 20171 Switzerland
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Study Endpoints
Primary Endpoints
Geometric mean concentration (GMC) of neutralizing antibodies to PT
At 28 days after vaccination
Secondary Endpoints
Safety endpoints evaluated by solicited local and systemic reactions and unsolicited adverse events (AEs)
Solicited local and systemic reactions will be followed up for 7 days and AEs for 28 days after vaccination
GMCs and seroresponse rates of PT, FHA, tetanus and diphtheria-toxoid specific IgG antibodies measured by ELISA
At 28 days after vaccination
Seroresponse rates of PT specific neutralizing antibodies Time Frame: At 28 days after vaccination
At 28 days after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arm 1: Pertagen® aP + Td-pur®EXPERIMENTALBioNet-Asia recombinant acellular Pertussis vaccine (Pertagen®) given simultaneously with Td-pur® vaccine (Novartis/GSK) intramuscularly as a single dose on Day 0
Arm 2: Boostrix® dTpaACTIVE_COMPARATORLicensed Tetanus-diphtheria (reduced dose)-acellular Pertussis vaccine (Boostrix® dTpa; GSK) given intramuscularly as a single dose on Day 0
Interventions
NameTypeDescription
Pertagen® aP + Td-pur®BIOLOGICALsee arm/group descriptions
Boostrix® dTpaBIOLOGICALsee arm/group descriptions
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Eligibility Criteria
Age Range11 Years — 15 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria The volunteer must satisfy the following criteria to be eligible for the study: 1. Has provided written informed consent before enrollment; 2. Male or female, ages 11-15 years (inclusive) at the time of enrollment; 3. With documented history of acellular pertussis immunization (...

Countries:Switzerland
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