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Meningococcal C Conjugate Vaccine

Phase 3

Prevention of Meningococcal Infection | Monoclonal antibody | Other |Novartis AG|Last Updated: Feb 8, 2012

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 Enrollment407
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00311415Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy ChildrenPHASE3 COMPLETED 257 — — Oct 1, 2005Apr 1, 2008Feb 8, 20122 Germany, Poland
NCT00310674Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of AgePHASE3 COMPLETED 150 — — Sep 1, 2004 -Mar 13, 20071 Italy
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Study Endpoints
Primary Endpoints
Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA.
Overall study period
antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.
safety and tolerability
Secondary Endpoints
Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.
Overall study period
antibody response as measured by ELISA at 1 month after second dose of MenC Vaccine and before third dose with hexavalent vaccine
antibody response as measured by BCA in subset of subjects in each group, at 1 month after second dose, immediately before the third and at 1 month following the third dose of MenC Vaccine together with a hexavalent vaccine.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1: 2+4 Months (2-doses)EXPERIMENTAL -
Group 2: 2 Months (1-dose)EXPERIMENTAL -
Group 3: 6 Months (1-dose)EXPERIMENTAL -
Group 4: 12-16 Months (1 dose in the second year of life)ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Meningococcal C conjugate vaccineBIOLOGICALMeningococcal conjugate vaccine, active comparator. Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age
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Eligibility Criteria
Age Range7 Weeks — 16 Weeks
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * healthy infants Exclusion Criteria: * known hypersensitivity to any vaccine component * significant acute or chronic infections * previously ascertained or suspected disease caused by N. meningitidis * previous household contact with an individual with a positive culture of ...

Countries:GermanyPolandItaly
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