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Meningococcal

Phase 2

Infections, Meningococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 21, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal · 3 trials · 1 indication

Phase 2 3
NCT00126945Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 YrsInfections, Meningococcal
COMPLETED125 Analytics
NCT00196963Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 YrsInfections, Meningococcal
COMPLETED125 Analytics
NCT00196950Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 YearsInfections, Meningococcal
COMPLETED50 Analytics
PHASE2COMPLETED
Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
Infections, MeningococcalUnlock trial analytics
PHASE2COMPLETED
Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
Infections, MeningococcalUnlock trial analytics
PHASE2COMPLETED
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
Infections, MeningococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e. 4-fold increase in serum bactericidal antibody [SBA] titre from pre to post vaccination) at 1 month after the first vaccine dose
% of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e.>= 4-fold increase in SBA titre from pre to post vaccination) at 1 month after the vaccine dose.
The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination.

Secondary Endpoints

Antibodies to MenACWY before + 1 m after dose 1, 12 m after dose 1 in control + with selected vaccine groups, 1 m after booster
Solicited, unsolicited symptoms after each dose and serious adverse events (SAEs)
Prophylaxis meningococcal serogroups A, C, W-135, Y disease
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Meningococcal VaccineBIOLOGICAL -
Meningococcal (vaccine)BIOLOGICAL -
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Eligibility Criteria

Age Range15 Years to 19 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination. * Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents'/guardians' knowledge. * Female subjects should be of non-ch...

Countries:DenmarkBelgium
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Frequently asked questions about Meningococcal

What is Meningococcal used for?

Meningococcal is a monoclonal antibody being developed by GSK plc for the prevention of meningococcal infections. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being studied in healthy subjects to evaluate its safety and immunogenicity when administered as a single dose.

What does Meningococcal target?

Meningococcal is a monoclonal antibody that targets meningococcal serogroups A, C, W-135, and Y. It is designed to provide protection against these specific serogroups of the Neisseria meningitidis bacteria, which cause meningococcal disease. The antibody is being evaluated for its ability to elicit an immune response against these serogroups.

Who makes Meningococcal?

Meningococcal is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting Phase 2 clinical trials to evaluate the safety and immunogenicity of this investigational monoclonal antibody for the prevention of meningococcal infections.

What phase is Meningococcal in?

Meningococcal is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 2 clinical trials have been completed, with a total enrollment of 300 healthy subjects. The drug is being studied for its potential to prevent meningococcal infections.

What clinical trials is Meningococcal in?

Meningococcal has completed three Phase 2 clinical trials. These include NCT00126945 and NCT00196963, which evaluated four different formulations of a meningococcal serogroups A, C, W-135, Y conjugate vaccine in healthy subjects aged 15-19 years, and NCT00196950, which evaluated the vaccine in healthy subjects aged 18-25 years. All trials were completed.

Is Meningococcal the same as a meningococcal conjugate vaccine?

Meningococcal is a monoclonal antibody being studied for the prevention of meningococcal infections. The clinical trials for this drug evaluate formulations of a meningococcal serogroups A, C, W-135, Y conjugate vaccine. The drug is being developed to target these specific serogroups of the bacteria that cause meningococcal disease.