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MenC-TT

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment1,000

FDA Designations

No designations recorded

Clinical trial landscape

MenC-TT · 2 trials · 1 indication

Phase 2 2
NCT00135564Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy ToddlersInfections, Meningococcal
COMPLETED500 Analytics
NCT00135486Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in InfantsInfections, Meningococcal
COMPLETED500 Analytics
PHASE2COMPLETED
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy Toddlers
Infections, MeningococcalUnlock trial analytics
PHASE2COMPLETED
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
Infections, MeningococcalUnlock trial analytics

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 to 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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Frequently asked questions about MenC-TT

What is MenC-TT used for?

MenC-TT is an investigational vaccine being studied for the prevention of meningococcal infections, specifically infections caused by Neisseria meningitidis serogroup C. It is being evaluated in infants and toddlers as part of GSK's meningococcal vaccine development program.

Who makes MenC-TT?

MenC-TT is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and is currently in clinical development.

What phase is MenC-TT in?

MenC-TT is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 2 studies have been completed, and the vaccine is not currently in active clinical trials.

What clinical trials is MenC-TT in?

MenC-TT has been studied in two completed Phase 2 trials. NCT00135486 evaluated the vaccine in infants starting at 8 weeks of age, and NCT00135564 evaluated it in toddlers starting at 12 months of age. Both trials enrolled healthy participants and focused on meningococcal infections.

How does MenC-TT work?

MenC-TT is a conjugate vaccine that links the capsular polysaccharide of Neisseria meningitidis serogroup C to a tetanus toxoid carrier protein. This design is intended to elicit a T-cell-dependent immune response, producing protective antibodies against serogroup C meningococcal disease.