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MenACWY-CRM conjugate vaccine

Phase 3

N. Meningitidis Carriage | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 21, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment2,968

FDA Designations

No designations recorded

Clinical trial landscape

MenACWY-CRM conjugate vaccine · 1 trial · 1 indication

Phase 3 1
NCT01214850Novartis Vaccine and Diagnostics Carriage TrialN. Meningitidis Carriage
COMPLETED2,968 Analytics
PHASE3COMPLETED
Novartis Vaccine and Diagnostics Carriage Trial
N. Meningitidis CarriageUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination
61 days (31 days after receiving the second injection)

Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported. Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.

Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination
31 days after MenACWY-CRM injection

The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.

Secondary Endpoints

Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination
Up to 361 days after vaccination
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Up to 361 days after vaccination
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Up to 361 days after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
rMenB+OMVEXPERIMENTALSubjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
MenACWYEXPERIMENTALSubjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
ControlACTIVE_COMPARATORSubjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart

Interventions

NameTypeDescription
Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)BIOLOGICAL -
MenACWY-CRM conjugate vaccineBIOLOGICAL -
Japanese Encephalitis vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 24 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment; * Subjects who were available for all the visits scheduled in the study; * Subjects who were in good health as determined by the outcome of medical history, physical examinati...

Countries:United Kingdom
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Frequently asked questions about MenACWY-CRM conjugate vaccine

What is MenACWY-CRM conjugate vaccine used for?

MenACWY-CRM conjugate vaccine is used for the prevention of meningococcal disease, meningococcal meningitis, and N. meningitidis carriage. It is an investigational vaccine being developed by Novartis AG for these infectious disease indications.

Who makes MenACWY-CRM conjugate vaccine?

MenACWY-CRM conjugate vaccine is being developed by Novartis AG, which trades under the ticker NVS. The vaccine is currently in clinical development for the prevention of meningococcal disease and related conditions.

What phase is MenACWY-CRM conjugate vaccine in?

MenACWY-CRM conjugate vaccine is in Phase 3 clinical development. It has completed two Phase 3 trials, including a carriage trial and a persistence study, along with two earlier Phase 2 trials.

What clinical trials is MenACWY-CRM conjugate vaccine in?

MenACWY-CRM conjugate vaccine has completed four clinical trials. These include NCT00262041 and NCT00310817 in Phase 2, and NCT00856297 and NCT01214850 in Phase 3, covering adolescents, children, and adults in multiple countries.

Is MenACWY-CRM conjugate vaccine the same as Novartis Meningococcal ACWY Conjugate Vaccine?

Yes, MenACWY-CRM conjugate vaccine is the same as the Novartis Meningococcal ACWY Conjugate Vaccine. Clinical trials refer to it by both names, with the vaccine being evaluated for safety and immunogenicity across different age groups.