Recent Updates
Recently added Catalysts

rLP2086 vaccine or control

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

rLP2086 vaccine or control · 1 trial · 1 indication

Phase 1 1
NCT00879814Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy AdultsMeningitis, Meningococcal
COMPLETED48 Analytics
PHASE1COMPLETED
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
Meningitis, Meningococcal
NCT0087981448
Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about rLP2086 vaccine or control

What is rLP2086 vaccine used for?

rLP2086 vaccine is an investigational vaccine being studied for the prevention of meningitis and meningococcal disease. It is being developed by Pfizer, Inc. and is currently in Phase 1 clinical development. The vaccine is intended to protect against meningococcal infections caused by Neisseria meningitidis.

Who makes rLP2086 vaccine?

rLP2086 vaccine is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The vaccine is currently in Phase 1 clinical development for the prevention of meningitis and meningococcal disease.

What phase is rLP2086 vaccine in?

rLP2086 vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, evaluating the safety and tolerability of the vaccine in healthy adults.

What clinical trials is rLP2086 vaccine in?

rLP2086 vaccine has one completed clinical trial, identified as NCT00879814. This Phase 1 study, titled 'Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults,' enrolled 48 participants in the United States. The trial was active-controlled and included adults aged 18 years and older.

Is rLP2086 vaccine the same as the meningococcal B vaccine?

rLP2086 vaccine is an investigational vaccine targeting meningococcal disease, specifically designed to address infections caused by Neisseria meningitidis serogroup B. It is being developed by Pfizer, Inc. and is currently in Phase 1 clinical trials. The vaccine is not yet approved and is being studied for safety and tolerability.