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Meningococcal Vaccine

Phase 2

Meningococcal Disease | Vaccine | Infectious Disease |Novartis AG|Trials Updated: Oct 24, 2011

Meningococcal Vaccine development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Aug 2005

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

Meningococcal Vaccine clinical trials

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 the Meningococcal Vaccine developed by Novartis AG?

It is an investigational vaccine developed by Novartis AG for the prevention of meningococcal disease, including meningococcal meningitis. It is a vaccine modality in Phase 2 clinical development. The program has been studied in adolescents, a population at risk for meningococcal infection.

What is the Meningococcal Vaccine used for?

The Meningococcal Vaccine is being developed for meningococcal disease and meningococcal meningitis. Its Phase 2 trial enrolled healthy adolescent volunteers aged 11 years and older in Chile, Colombia, and Panama. It is an investigational product and is not described as approved for use.

Who makes the Meningococcal Vaccine?

Novartis AG, which trades under the ticker NVS, is the developer of this Meningococcal Vaccine. The company sponsored the Phase 2 study evaluating different rMenB plus MenACWY formulations in adolescents.

What phase is the Meningococcal Vaccine in?

The Meningococcal Vaccine is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The completed study was randomized and active controlled, with 495 participants enrolled.

What clinical trials is the Meningococcal Vaccine in?

The Meningococcal Vaccine has been evaluated in one completed Phase 2 trial, NCT01210885, titled Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents. It enrolled 495 healthy volunteers aged 11 years and older across Chile, Colombia, and Panama and used an active-controlled, randomized design.