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Meningococcal vaccine 134612

Phase 2

Infections, Meningococcal | Monoclonal antibody | Other |GSK plc|Last Updated: Jun 8, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment919
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00454909Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.PHASE2 COMPLETED 873 — — Apr 23, 2007Apr 11, 2008Jun 8, 201810 United States
NCT00390143Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612PHASE2 COMPLETED 46 — — Feb 1, 2007May 1, 2009Oct 25, 20161 Denmark
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Study Endpoints
Primary Endpoints
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
At Day 0 (PRE)

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.

Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
At Month 1

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.

Meningococcal rSBA titres.
At the start of this persistence study and 12 and 24 months later.
Anti-meningococcal polysaccharide concentrations
At the start of this persistence study and 12 and 24 months later.
Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation.
From the last study contact of the primary vaccination study to the end of this persistence study.
Secondary Endpoints
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
At Day 0 (PRE) and Month 1
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
At Day 0 (PRE) and Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALSubjects aged 10 years (\< 11 years) vaccinated with meningococcal vaccine GSK134612.
Group BEXPERIMENTALSubjects aged 11 to 25 years vaccinated with meningococcal vaccine GSK134612.
Group CACTIVE_COMPARATORSubjects aged 11 to 25 years vaccinated with Menactra®.
Interventions
NameTypeDescription
Meningococcal vaccine 134612BIOLOGICALSingle dose intramuscular injection.
Menactra®BIOLOGICALSingle dose intramuscular injection.
Mencevax™ ACWYBIOLOGICALOne subcutaneous dose during the primary study
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Eligibility Criteria
Age Range10 Years — 25 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * Subjects whom the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination. * Written informed consent obtained fro...

Countries:United StatesDenmark
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