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MnB vaccine rLP8026

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 8, 2008

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

Clinical trial landscape

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 used for?

MnB vaccine rLP8026 is an investigational vaccine being studied for use in healthy individuals. It is being evaluated for safety and immunogenicity in healthy toddlers aged 18 months and older. The vaccine is currently in Phase 1 clinical development and has not been approved for any indication.

Who makes MnB vaccine rLP8026?

MnB vaccine rLP8026 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine in healthy toddlers.

What phase is MnB vaccine rLP8026 in?

MnB vaccine rLP8026 is in Phase 1 clinical development. It is an investigational vaccine that has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under investigation for use in healthy individuals.

What clinical trials is MnB vaccine rLP8026 in?

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

Is MnB vaccine rLP8026 the same as rLP2086?

Yes, MnB vaccine rLP8026 is also known as rLP2086. The completed Phase 1 clinical trial NCT00387569 evaluated the safety and immunogenicity of the rLP2086 vaccine in healthy toddlers. This alternative name is used in the clinical trial record for the same investigational vaccine.