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meningococcal B rLP2086 vaccine candidate

Phase 1

Meningitis, Meningococcal | Vaccine | Infectious Disease |Pfizer, Inc.|Trials Updated: Aug 23, 2011

meningococcal B rLP2086 vaccine candidate development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

meningococcal B rLP2086 vaccine candidate clinical trials

meningococcal B rLP2086 vaccine candidate · 1 trial · 1 indication

Phase 1 1
NCT00780806Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In AdultsMeningitis, Meningococcal
COMPLETED60 Analytics
PHASE1COMPLETED
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
Meningitis, MeningococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study
Up to 2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
1EXPERIMENTALImmunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months

Interventions

NameTypeDescription
meningococcal B rLP2086 vaccine candidateBIOLOGICALvaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months
Blood drawPROCEDUREBlood draw
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male or female subject between the ages of \>=18 and \<=40 years * Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study. * All female or male subjects who are biologicall...

Countries:Australia
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Frequently asked questions about meningococcal B rLP2086 vaccine candidate

What is the meningococcal B rLP2086 vaccine candidate?

The meningococcal B rLP2086 vaccine candidate is an investigational vaccine developed by Pfizer for the prevention of meningococcal B disease, including meningitis. It is designed to prompt an immune response against Neisseria meningitidis serogroup B. It has been studied in a Phase 1 clinical trial in healthy adult volunteers.

What is the meningococcal B rLP2086 vaccine candidate used for?

The meningococcal B rLP2086 vaccine candidate is being developed for the prevention of meningitis and meningococcal disease caused by serogroup B Neisseria meningitidis. It is intended for use in healthy individuals to reduce the risk of invasive meningococcal B infection. It remains investigational and is not an approved product.

Who is developing the meningococcal B rLP2086 vaccine candidate?

Pfizer, Inc. (ticker PFE) is the developer of the meningococcal B rLP2086 vaccine candidate. Pfizer sponsored the Phase 1 clinical study of the vaccine conducted in Australia. The candidate is part of Pfizer's infectious disease vaccine pipeline.

What phase is the meningococcal B rLP2086 vaccine candidate in?

The meningococcal B rLP2086 vaccine candidate is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. As an investigational vaccine candidate, it has not been approved by the FDA for any indication.

What clinical trials is the meningococcal B rLP2086 vaccine candidate in?

The meningococcal B rLP2086 vaccine candidate has been evaluated in one completed Phase 1 trial, NCT00780806, titled Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults. The trial enrolled 60 healthy adult volunteers aged 18 years and older in Australia and used a randomized, uncontrolled design.