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Phase 2

Meningococcal Vaccine | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Oct 27, 2022

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,714
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01299480A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 YearsPHASE2 COMPLETED 1,714Mar 3, 2011Sep 18, 2012Oct 27, 202263 Czechia, Denmark +5
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants
1 month after Injection 4
Percentage of Participants Reporting At Least 1 Adverse Event (AE)
Injection 1 up to 1 month after Injection 4
Secondary Endpoints
Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants
1 month after Injection 4
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4
Percentage of Participants Achieving hSBA Titer >=LLOQ
Before Injection 1, 1 Month after Injection 2, 3, 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALrLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Group 2EXPERIMENTALrLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Group 3EXPERIMENTALrLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Group 4EXPERIMENTALrLP2086 at visits 1 and 3, saline at visits 2 and 5
Group 5EXPERIMENTALrLP2086 at visits 3 and 5, saline at visits 1 and 2
Interventions
NameTypeDescription
VaccineBIOLOGICALrLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
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Eligibility Criteria
Age Range11 Years — 18 Years
SexALL
Healthy VolunteersYes
Study Sites63

Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study. * Parent/legally acceptable representative and/or subjects who are willing a...

Countries:CzechiaDenmarkFinlandGermanyPolandSpainSweden
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