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Meningococcal serogroup B vaccine

Phase 2

Infections, Meningococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 16, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment478

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal serogroup B vaccine · 1 trial · 1 indication

Phase 2 1
NCT00137917Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 YrsInfections, Meningococcal
COMPLETED478 Analytics
PHASE2COMPLETED
Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
Infections, MeningococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed

Secondary Endpoints

For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)
After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30)
Serious adverse events [SAEs] (whole study)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Meningococcal serogroup B vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range12 Years to 18 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination. * Female subjects must be of non-childbearing potential. Exclusion Criteria: * Previous vaccination against or history of meningococcal B or C, or hepatitis A diseas...

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Frequently asked questions about Meningococcal serogroup B vaccine

What is Meningococcal serogroup B vaccine used for?

Meningococcal serogroup B vaccine is an investigational vaccine being studied for the prevention of meningococcal infections. It is intended for use in healthy adolescents aged 12 to 18 years. The vaccine is currently in clinical development and has not been approved for use.

Who makes Meningococcal serogroup B vaccine?

Meningococcal serogroup B vaccine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in the target adolescent population.

What phase is Meningococcal serogroup B vaccine in?

Meningococcal serogroup B vaccine is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine remains under investigation for its intended use.

What clinical trials is Meningococcal serogroup B vaccine in?

Meningococcal serogroup B vaccine has been studied in one completed Phase 2 clinical trial, identified as NCT00137917. This trial evaluated the immunogenicity and safety of a three-dose schedule of the vaccine in healthy adolescents aged 12 to 18 years. The trial enrolled 478 participants.

Is Meningococcal serogroup B vaccine a monoclonal antibody?

Meningococcal serogroup B vaccine is classified as a monoclonal antibody modality, although it is being developed as a vaccine. The investigational product is designed to elicit an immune response against meningococcal serogroup B bacteria, which cause meningococcal infections.