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meningococcal B rLP2086 vaccine

Phase 2

Meningitis, Meningococcal | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 14, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment538

FDA Designations

No designations recorded

Clinical trial landscape

meningococcal B rLP2086 vaccine · 1 trial · 1 indication

Phase 2 1
NCT00808028A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In AdolescentsMeningitis, Meningococcal
COMPLETED538 Analytics
PHASE2COMPLETED
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Meningitis, MeningococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
Before vaccination 1 up to 1 month after vaccination 2
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
Before vaccination 1 up to 1 month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Vaccination 1 upto 1 Month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
6 month after vaccination 3 up to 48 months

Secondary Endpoints

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
1 month before vaccination 1, 1 month after vaccination 2, 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALdose level 1 rLP2086 vaccine
2EXPERIMENTALdose level 2 rLP2086 vaccine
3EXPERIMENTALdose level 3 rLP2086 vaccine
4PLACEBO_COMPARATORnormal saline (placebo)

Interventions

NameTypeDescription
meningococcal B rLP2086 vaccine.BIOLOGICALvaccine, 0.5 mL, 0 - 2 - 6 to 9 months
normal saline (placebo)OTHERvaccine, 0.5 mL, 0 - 2 - 6 to 9 months
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Eligibility Criteria

Age Range11 Years to 18 Years
SexALL
Healthy VolunteersYes
Study Sites27

Inclusion Criteria: * Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment. * Negative urine pregnancy test for all female subjects. * Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant...

Countries:AustraliaPolandSpain
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Frequently asked questions about meningococcal B rLP2086 vaccine

What is meningococcal B rLP2086 vaccine used for?

Meningococcal B rLP2086 vaccine is an investigational vaccine being studied for the prevention of meningitis and meningococcal disease. It is designed to protect against infections caused by Neisseria meningitidis serogroup B. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

Who makes meningococcal B rLP2086 vaccine?

Meningococcal B rLP2086 vaccine is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The vaccine is currently in Phase 2 clinical development for the prevention of meningococcal disease.

What phase is meningococcal B rLP2086 vaccine in?

Meningococcal B rLP2086 vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The vaccine is being studied for its safety and immunogenicity in adolescents, with one completed Phase 2 trial.

What clinical trials is meningococcal B rLP2086 vaccine in?

Meningococcal B rLP2086 vaccine has been evaluated in one completed Phase 2 clinical trial, identified as NCT00808028. This study assessed the safety and immunogenicity of the vaccine in adolescents aged 11 years and older, enrolling 538 participants across Australia, Poland, and Spain.

Is meningococcal B rLP2086 vaccine the same as Trumenba?

Meningococcal B rLP2086 vaccine is the investigational name for the vaccine that was later marketed as Trumenba. The clinical trial data provided refers to the vaccine under its developmental name, rLP2086, which is the same product that received approval for meningococcal serogroup B prevention.