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rLP2086 vaccine or control

Phase 1

Meningitis, Meningococcal | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 6, 2015

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00879814Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy AdultsPHASE1 COMPLETED 48 — — Apr 1, 2009Jul 1, 2012Aug 6, 20151 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With at Least One Adverse Event (AE)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).
Baseline up to Month 7
Secondary Endpoints
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALrLP2086 vaccine 60 mcg
2EXPERIMENTALrLP2086 vaccine 120 mcg
3EXPERIMENTALrLP2086 vaccine 200 mcg
4ACTIVE_COMPARATORTdap vaccine - normal saline - normal saline
Interventions
NameTypeDescription
rLP2086 vaccine or controlBIOLOGICALintra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study: * Male or female subjects between the ages of 18 and 40. * Healthy male or female subjects as determined by medical history, ...

Countries:United States
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