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V232 Modified Process Hepatitis B Vaccine: Lot A

Phase 3

Hepatitis B Infection | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Mar 16, 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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment860
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00489099A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)PHASE3 COMPLETED 860 — — Jun 1, 2005May 1, 2006Mar 16, 2017 - —
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Study Endpoints
Primary Endpoints
Number of Participants with Seroprotection to Hepatitis B Surface Antigen
1 month after the third vaccination (Month 7)
Geometric Mean Titers to Hepatitis B Surface Antigen
1 month after the third vaccination (Month 7)
Secondary Endpoints
Percentage of Participants with an Adverse Experience
Up to 15 days after any vaccination
Percentage of Participants with an Injection-site Adverse Experience
Up to 15 days after any vaccination
Percentage of Participants with a Systemic Adverse Experience
Up to 15 days after any vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
V232 Modified Process Hepatitis B Vaccine: Lot AEXPERIMENTALRecombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Modified Process Hepatitis B Vaccine: Lot BEXPERIMENTALRecombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Modified Process Hepatitis B Vaccine: Lot CEXPERIMENTALRecombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Current Process Hepatitis B VaccineACTIVE_COMPARATORRecombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Interventions
NameTypeDescription
V232 Modified Process Hepatitis B Vaccine: Lot ABIOLOGICAL -
V232 Modified Process Hepatitis B Vaccine: Lot BBIOLOGICAL -
V232 Modified Process Hepatitis B Vaccine: Lot CBIOLOGICAL -
V232 Current Process Hepatitis B VaccineBIOLOGICAL -
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Eligibility Criteria
Age Range20 Years — 35 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * In general good health * Female participants have a negative pregnancy test just prior to vaccination on Day 1 Exclusion Criteria: * History of Hepatitis B Infection or vaccination * Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., alumin...

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