Recent Updates
Recently added Catalysts

Meningococcal

Phase 2

Infections, Meningococcal | Vaccine | Infectious Disease |GSK plc|Trials Updated: Sep 21, 2016

Meningococcal target and mechanism

ModalityVaccine

Also known as Meningococcal (vaccine)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment300

FDA Designations

No designations recorded

Meningococcal clinical trials

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Meningococcal VaccineBIOLOGICAL -
Meningococcal (vaccine)BIOLOGICAL -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Meningococcal

What is the Meningococcal vaccine?

The Meningococcal vaccine is an investigational vaccine developed by GSK plc for the prevention of meningococcal infections. It targets meningococcal serogroups A, C, W-135, and Y, and is being studied in healthy adolescent and young adult volunteers. It is a vaccine modality in the infectious disease therapeutic area.

What is the Meningococcal vaccine used for?

The Meningococcal vaccine is being studied for the prevention of infections caused by meningococcal serogroups A, C, W-135, and Y. Clinical trials have enrolled healthy subjects aged 15 to 25 years. The vaccine is investigational and has not been established as an approved product based on the available development information.

Who makes the Meningococcal vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the Meningococcal vaccine. The company has sponsored Phase 2 clinical trials evaluating different formulations of the vaccine in healthy volunteers.

What phase is the Meningococcal vaccine in?

The Meningococcal vaccine is in Phase 2 clinical development. All three of its recorded trials are Phase 2 studies, and all three have been completed. No active trials are currently listed, and the vaccine remains investigational rather than approved.

What clinical trials is the Meningococcal vaccine in?

Three completed Phase 2 trials have evaluated the Meningococcal vaccine: NCT00196963 in Belgium with 125 subjects, NCT00196950 in Belgium with 50 subjects, and NCT00126945 in Denmark with 125 subjects. Together these studies enrolled approximately 300 healthy volunteers aged 15 to 25 years.

Is the Meningococcal vaccine the same as Meningococcal?

Yes. Meningococcal, Meningococcal (vaccine), and Meningococcal Vaccine are alternative names for the same GSK plc vaccine candidate. All refer to the investigational vaccine targeting meningococcal serogroups A, C, W-135, and Y that GSK is developing in Phase 2 trials.