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Meningococcal C Conjugate Vaccine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment407

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal C Conjugate Vaccine · 2 trials · 1 indication

Phase 3 2
NCT00311415Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy ChildrenPrevention of Meningococcal Infection
COMPLETED257 Analytics
NCT00310674Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of AgePrevention of Meningococcal Infection
COMPLETED150 Analytics
PHASE3COMPLETED
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
Prevention of Meningococcal Infection
NCT00311415257
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PHASE3COMPLETED
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age
Prevention of Meningococcal Infection
NCT00310674150
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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 to 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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Frequently asked questions about Meningococcal C Conjugate Vaccine

What is Meningococcal C Conjugate Vaccine used for?

Meningococcal C Conjugate Vaccine is used for the prevention of meningococcal infection. It is an investigational vaccine being developed by Novartis AG (NVS) for this infectious disease indication. The vaccine is currently in Phase 3 clinical development.

Who makes Meningococcal C Conjugate Vaccine?

Meningococcal C Conjugate Vaccine is being developed by Novartis AG, which trades under the ticker NVS. The vaccine is currently in Phase 3 clinical trials for the prevention of meningococcal infection.

What phase is Meningococcal C Conjugate Vaccine in?

Meningococcal C Conjugate Vaccine is in Phase 3 clinical development. It is an investigational vaccine for the prevention of meningococcal infection and has not been approved for use. Two Phase 3 trials have been completed.

What clinical trials is Meningococcal C Conjugate Vaccine in?

Meningococcal C Conjugate Vaccine has completed two Phase 3 trials. NCT00310674 enrolled 150 healthy infants in Italy, and NCT00311415 enrolled 257 healthy children in Germany and Poland. Both trials studied the vaccine's immunogenicity, safety, and tolerability for preventing meningococcal infection.

Is Meningococcal C Conjugate Vaccine a monoclonal antibody?

Meningococcal C Conjugate Vaccine is classified as a monoclonal antibody modality, though it is being studied as a vaccine for the prevention of meningococcal infection. It is currently in Phase 3 clinical development by Novartis AG.