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Meningococcal Vaccine

Phase 2

Meningococcal Disease | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Oct 24, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment495

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal Vaccine · 1 trial · 2 indications

Phase 2 1
NCT01210885Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in AdolescentsMeningococcal Disease
COMPLETED495 Analytics
PHASE2COMPLETED
Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents
Meningococcal DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs)
3 months
Percentage of subjects with seroresponse, and human Serum Bactericidal Activity (hSBA) titer ≥ 1:8 and hSBA titer ≥ 1:4 to Neisseria meningitidis serogroups A, C, W-135 and Y
3 months
Percentage of subjects with hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains
3 months
Number of participants with solicited local and systemic reactions
within 7 days after each vaccination
Number of participants with any adverse events (AEs)
6 months
Number of participants with Serious Adverse Events (SAEs)
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group I: Investigational MenABCWY Formulation 1EXPERIMENTAL -
Group II: Investigational MenABCWY Formulation 2EXPERIMENTAL -
Group III: Investigational MenABCWY Formulation 3EXPERIMENTAL -
Group IV: Investigational MenABCWY Formulation 4EXPERIMENTAL -
Group V: Active comparator investigational MenBACTIVE_COMPARATOR -
Group VI: Active comparator MenACWYACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Meningococcal VaccineBIOLOGICALMenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
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Eligibility Criteria

Age Range11 Years to 18 Years
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: Individuals eligible to be enrolled into this study are male and female subjects: 1. 11-18 years at the time of enrollment; 2. who have given their written consent/assent and whose parents or legal guardians have given written informed consent at the time of enrollment; 3. who ...

Countries:ChileColombiaPanama
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Frequently asked questions about Meningococcal Vaccine

What is Meningococcal Vaccine used for?

Meningococcal Vaccine is used for the prevention of meningococcal disease, including meningococcal meningitis. It is an investigational vaccine being developed by Novartis AG for use in adolescents. The vaccine is designed to protect against infection caused by Neisseria meningitidis bacteria.

Who makes Meningococcal Vaccine?

Meningococcal Vaccine is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in clinical development for the prevention of meningococcal disease.

What phase is Meningococcal Vaccine in?

Meningococcal Vaccine is currently in Phase 2 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The vaccine is being studied for its immunogenicity and safety in adolescents for the prevention of meningococcal disease.

What clinical trials is Meningococcal Vaccine in?

Meningococcal Vaccine has been studied in one completed Phase 2 clinical trial, identified as NCT01210885. This trial, titled 'Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents,' enrolled 495 participants aged 11 years and older in Chile, Colombia, and Panama. The trial was active-controlled and included healthy volunteers.

How does Meningococcal Vaccine work?

Meningococcal Vaccine is a monoclonal antibody-based vaccine. It works by stimulating the immune system to produce antibodies against Neisseria meningitidis, the bacteria that cause meningococcal disease. The vaccine contains components designed to elicit a protective immune response against multiple serogroups of the bacteria.

Is Meningococcal Vaccine the same as rMenB Plus MenACWY?

Meningococcal Vaccine is being studied in combination with MenACWY, as indicated by the clinical trial title 'Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents.' The trial evaluated different formulations of the vaccine, suggesting that the meningococcal vaccine may be combined with other components to provide broader protection.