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MenC-TT

Phase 2

Infections, Meningococcal | Monoclonal antibody | Other |GSK plc|Last Updated: Sep 16, 2016

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
RandomizedUNCONTROLLED
Total Trials2
Total Enrollment1,000
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00135564Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy ToddlersPHASE2 COMPLETED 500 — — Jan 1, 2003Jul 1, 2003Sep 16, 2016 - —
NCT00135486Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in InfantsPHASE2 COMPLETED 500 — — Mar 1, 2002Jan 1, 2003Sep 16, 2016 - —
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Study Endpoints
Primary Endpoints
Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups
Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers
Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations
Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations
Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA
Prior to and one month after the 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Prior to and one month after the 3rd vaccine dose
Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL
Prior to and one month after the 3rd vaccine dose
Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL
Prior to and one month after the 3rd vaccine dose
Vaccine response to pertussis toxoid (PT)
Prior to 3rd vaccine dose
Evaluation of anti-diphtheria antibody concentrations
Prior to 3rd vaccine dose
Anti-poliovirus types 1, 2 and 3 antibody titers
Prior to and one month after the 3rd vaccine dose
Occurrence of solicited local injection site symptoms
During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of solicited systemic symptoms
During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of unsolicited non-serious adverse events (AEs)
Within one month (Day 0 30) after each vaccination
Occurrence of any serious adverse events (SAEs)
Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose
Vaccine response to filamentous haemagglutinin (FHA)
Prior to 3rd vaccine dose
Vaccine response to pertactin (PRN)
Prior to 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations
Prior to 3rd vaccine dose
Evaluation of anti-HBs antibody concentrations
Prior to 3rd vaccine dose
Evaluation of anti-PT antibody concentrations
Prior to 3rd vaccine dose
Evaluation of anti-FHA antibody concentrations
Prior to 3rd vaccine dose
Evaluation of anti-PRN antibody concentrations
Prior to 3rd vaccine dose
Secondary Endpoints
Prior to dose 1, 1 m post doses 2, 3: anti-PRP
Prior to dose 1, 1 m post dose 3: anti-diphtheria, T, HBs, polio, PT, FHA, PRN
Solicited (days [d] 0-7), unsolicited (up to 30 d) adverse events (AEs) after each dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
MenC-TTBIOLOGICAL -
Hib-MenC-TTBIOLOGICAL -
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Eligibility Criteria
Age Range12 Months — 15 Months
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of MenC or Hib-MenC vaccine in study 711202/001, OR without previous vaccination against MenC disease but with completed primary vaccination according to the German Standing Committee on Immunizat...

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