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meningococcal ACWY

Phase 2

Infections, Meningococcal | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jul 3, 2018

meningococcal ACWY target and mechanism

ModalityVaccine

Also known as meningococcal ACWY (vaccine)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

meningococcal ACWY clinical trials

meningococcal ACWY · 1 trial · 1 indication

Phase 2 1
NCT00356369Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate VaccineInfections, Meningococcal
COMPLETED500 Analytics
PHASE2COMPLETED
Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine
Infections, MeningococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)
One month post vaccination

Response to vaccine antigen was defined as: for initially seronegative subjects \[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.

Occurrence of Any Grade 3 Systemic Symptoms
During the 4-day (Days 0-3) post-vaccination period

Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \>39.5 °C.

Secondary Endpoints

Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value
Prior to and 1 Month after vaccination
rSBA Antibody Titers
Prior to and 1 Month after vaccination
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies
Prior to and 1 Month after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Nimenrix GroupEXPERIMENTALSubjects receiving GSK Biologicals' meningococcal vaccine 134612
Mencevax GroupACTIVE_COMPARATORSubjects receiving Mencevax™ ACWY

Interventions

NameTypeDescription
meningococcal ACWY (vaccine)BIOLOGICALOne intramuscular dose.
Mencevax™ ACWYBIOLOGICALOne subcutaneous dose.
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Eligibility Criteria

Age Range11 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol. * A male or female between, and including, 11 and 55 years of age at the time of vaccination. * Written informed ...

Countries:PhilippinesSaudi Arabia
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Frequently asked questions about meningococcal ACWY

What is meningococcal ACWY?

Meningococcal ACWY is a vaccine being developed by GSK plc for the prevention of meningococcal infections. It is designed to protect against meningococcal serogroups A, C, W, and Y. The vaccine is in Phase 2 clinical development and has been studied in adolescents and adults.

What is meningococcal ACWY used for?

Meningococcal ACWY is intended for the prevention of infections caused by meningococcal bacteria, specifically serogroups A, C, W, and Y. It is being evaluated in adolescents and adults, including healthy volunteers. The vaccine targets the infectious disease therapeutic area.

Who makes meningococcal ACWY?

Meningococcal ACWY is developed by GSK plc, which trades under the ticker GSK. GSK conducted a Phase 2 study of the vaccine in adolescents and adults to evaluate non-inferiority and persistence of immune response up to five years.

What phase is meningococcal ACWY in?

Meningococcal ACWY is in Phase 2 clinical development. It is an investigational vaccine and is not approved. One Phase 2 trial has been completed, and no trials are currently active. The completed study enrolled 500 participants.

What clinical trials is meningococcal ACWY in?

Meningococcal ACWY has been studied in one completed Phase 2 trial, NCT00356369, titled a study in adolescents and adults to evaluate non-inferiority and persistence up to five years of the GSK Bio MenACWY conjugate vaccine. The trial enrolled 500 participants across the Philippines and Saudi Arabia.

Is meningococcal ACWY the same as meningococcal ACWY (vaccine)?

Yes, meningococcal ACWY is also known as meningococcal ACWY (vaccine). Both names refer to the same GSK plc vaccine candidate for meningococcal serogroups A, C, W, and Y, which is in Phase 2 development for the prevention of meningococcal infections.