Recent Updates
Recently added Catalysts

rLP2086 vaccine or control

Phase 1

Meningitis, Meningococcal | Vaccine | Infectious Disease |Pfizer, Inc.|Trials Updated: Aug 6, 2015

rLP2086 vaccine or control development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2009

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

rLP2086 vaccine or control clinical trials

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 the rLP2086 vaccine or control?

The rLP2086 vaccine or control is an investigational meningococcal B vaccine candidate developed by Pfizer, Inc. (NYSE: PFE). It is designed to prevent meningitis caused by Neisseria meningitidis serogroup B. The candidate has been studied in a Phase 1 clinical trial in healthy adults.

What is the rLP2086 vaccine or control used for?

The rLP2086 vaccine or control is being developed for the prevention of meningococcal meningitis, specifically disease caused by Neisseria meningitidis serogroup B. It is intended for use in healthy adults, as studied in a Phase 1 trial.

Who makes the rLP2086 vaccine or control?

Pfizer, Inc. (NYSE: PFE) is the developer of the rLP2086 vaccine or control. Pfizer conducted the Phase 1 clinical trial evaluating the vaccine candidate.

What phase is the rLP2086 vaccine or control in?

The rLP2086 vaccine or control is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 trial has been completed.

What clinical trials is the rLP2086 vaccine or control in?

The rLP2086 vaccine or control has been evaluated in one completed Phase 1 clinical trial: NCT00879814, titled "Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults." The trial enrolled 48 participants in the United States and was active-controlled and randomized.

Explore more on BiopharmaWatch

Pfizer, Inc. (PFE)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with RCompanies A to ZEvery biotech and pharma company we track