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MnB vaccine rLP8026

Phase 1

Undisclosed | Vaccine | Other |Pfizer, Inc.|Trials Updated: May 8, 2008

MnB vaccine rLP8026 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

MnB vaccine rLP8026 clinical trials

MnB vaccine rLP8026 · 1 trial · 1 indication

Phase 1 1
NCT00387569Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy ToddlersHealthy
COMPLETED99 Analytics
PHASE1COMPLETED
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
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Study Endpoints

Primary Endpoints

Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months
Vaccinations at 0,1,6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALExperimental (20ug); Active Comparator/Placebo
Cohort 2EXPERIMENTALExperimental (60ug); Active Comparator/Placebo
Cohort 3EXPERIMENTALExperimental (200ug); Active Comparator/Placebo

Interventions

NameTypeDescription
MnB vaccine rLP8026BIOLOGICALMnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
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Eligibility Criteria

Age Range18 Months to 36 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Aged 18- to 36-months * Healthy male or female subjects Exclusion Criteria * Prior vaccination with a serogroup B meningococcal vaccine * Prior history of any invasive meningococcal disease

Countries:Australia
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Frequently asked questions about MnB vaccine rLP8026

What is MnB vaccine rLP8026?

MnB vaccine rLP8026 is an investigational vaccine developed by Pfizer, Inc. for meningococcal B disease. It is a Phase 1 candidate that has been studied in healthy toddlers. The vaccine is designed to be given to young children, and its clinical program has focused on safety and immune response in that age group.

Who makes MnB vaccine rLP8026?

MnB vaccine rLP8026 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the vaccine in healthy toddlers. The candidate is part of Pfizer's vaccine pipeline and has not been approved for commercial use.

What phase is MnB vaccine rLP8026 in?

MnB vaccine rLP8026 is in Phase 1 clinical development. It is an investigational vaccine and is not approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this candidate. The completed study enrolled 99 healthy toddlers in Australia.

What clinical trials is MnB vaccine rLP8026 in?

MnB vaccine rLP8026 has been studied in one completed Phase 1 trial, NCT00387569, titled Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers. The trial enrolled 99 participants aged 18 months and older in Australia. It was randomized, double-blind, and controlled, and it enrolled healthy volunteers.

What was the design of the MnB vaccine rLP8026 Phase 1 trial?

The Phase 1 trial of MnB vaccine rLP8026, NCT00387569, was a randomized, double-blind, controlled study in healthy toddlers. It enrolled 99 participants in Australia, with a minimum age of 18 months and no sex restriction. The study assessed safety and immunogenicity and has been completed.