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Mencevax ACWY

Phase 4

Infections, Meningococcal | Monoclonal antibody | Infectious Disease |GSK plc|Trials Updated: Nov 26, 2018

Mencevax ACWY development status

Highest phase Phase 4 (NCT00227422)
Phase scored for GSKPhase 3
Registered trials 5 across 1 sponsor since Aug 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,170

FDA Designations

No designations recorded

Mencevax ACWY clinical trials

Mencevax ACWY · 1 trial · 1 indication

Phase 3 1
NCT01154088Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year OldsInfections, Meningococcal
COMPLETED1,170 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds
Infections, MeningococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
At Month 1

Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
At Month 1

Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.

Secondary Endpoints

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
At Day 0 and at Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
At Day 0 and at Month 1
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
At Day 0 and at Month 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Mencevax ACWYBIOLOGICALOne dose, Subcutaneous injection
GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]BIOLOGICALOne dose, Intramuscular injection
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Eligibility Criteria

Age Range18 Years to 25 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: All subjects must satisfy all of the following criteria at study entry: * Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study. * A male or female between, and including, 18 and 25 years of age the ...

Countries:PanamaPhilippinesThailand
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Frequently asked questions about Mencevax ACWY

What is Mencevax ACWY?

Mencevax ACWY is a vaccine developed by GSK plc for the prevention of meningococcal infections. It is a Phase 3 candidate studied in healthy adults aged 18 to 25 years. Mencevax ACWY has been evaluated in a single completed clinical trial with 1,170 participants across Panama, the Philippines, and Thailand.

What is Mencevax ACWY used for?

Mencevax ACWY is used for protection against meningococcal infections. Its clinical development has focused on healthy adults aged 18 to 25 years. The only registered trial of Mencevax ACWY studied immunization against meningococcal disease in this age group across sites in Panama, the Philippines, and Thailand.

Who makes Mencevax ACWY?

Mencevax ACWY is made by GSK plc, which trades under the ticker GSK. GSK is the developer of the vaccine and sponsored the Phase 3 trial evaluating it. The study compared the immunogenicity and safety of another meningococcal vaccine candidate, GSK 134612, against Mencevax ACWY as the active control.

What phase is Mencevax ACWY in?

Mencevax ACWY has been studied in Phase 3 clinical development. Its single registered trial, NCT01154088, is completed, and no trials of Mencevax ACWY are currently active. The Phase 3 study enrolled 1,170 healthy adults aged 18 to 25 years and used a randomized, double-blind, active-controlled design.

What clinical trials is Mencevax ACWY in?

Mencevax ACWY was evaluated in one completed Phase 3 trial, NCT01154088, titled Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax ACWY in Healthy 18-25 Year Olds. The trial enrolled 1,170 healthy volunteers of all sexes in Panama, the Philippines, and Thailand and was randomized, double-blind, and active-controlled.

Is Mencevax ACWY the same as MencevaxACWY or Mencevax-ACWY?

Yes. Mencevax ACWY, MencevaxACWY, Mencevax-ACWY, and the trademarked forms Mencevax ACWY and Mencevax ACWY all refer to the same GSK plc meningococcal vaccine candidate. The spacing, hyphenation, and trademark symbols are formatting variations of the same product name used across sources.