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Meningococcal ACWY Polysaccharide Vaccine

Phase 3

Meningococcal Meningitis | Vaccine | Infectious Disease |Novartis AG|Trials Updated: Apr 21, 2014

Meningococcal ACWY Polysaccharide Vaccine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment2,831

FDA Designations

No designations recorded

Meningococcal ACWY Polysaccharide Vaccine clinical trials

Meningococcal ACWY Polysaccharide Vaccine · 1 trial · 2 indications

Phase 3 1
NCT00474487A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy AdultsMeningococcal Meningitis
COMPLETED2,831 Analytics
PHASE3COMPLETED
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
Meningococcal MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years
Days 1 to 7

Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.

Secondary Endpoints

Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population
1 month postvaccination
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population
1 month postvaccination
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population
1 month postvaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Novartis MenACWY Vaccine (19 to 55 Years)EXPERIMENTALNovartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years
Licensed polysaccharide vaccineACTIVE_COMPARATORLicensed meningococcal ACWY polysaccharide vaccine
Licensed Conjugate VaccineACTIVE_COMPARATORLicensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Novartis MenACWY Vaccine (56 to 65 Years)EXPERIMENTALNovartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years

Interventions

NameTypeDescription
Meningococcal ACWY Polysaccharide VaccineBIOLOGICALOne dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
MenACWY CRM (19 to 55 years)BIOLOGICALOne dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
Meningococcal ACWY Conjugate VaccineBIOLOGICALOne dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
Novartis MenACWY Vaccine (56 to 65 Years)BIOLOGICALOne dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.
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Eligibility Criteria

Age Range19 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent * individuals who are available for all visits and telephone calls scheduled for the study; * individuals who are in good health E...

Countries:ArgentinaColombia
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Frequently asked questions about Meningococcal ACWY Polysaccharide Vaccine

What is Meningococcal ACWY Polysaccharide Vaccine?

Meningococcal ACWY Polysaccharide Vaccine is an investigational vaccine developed by Novartis AG for protection against meningococcal meningitis. It is designed to stimulate an immune response against meningococcal serogroups A, C, W, and Y. The vaccine has been studied in a Phase 3 clinical trial involving 2,831 healthy adults.

What is Meningococcal ACWY Polysaccharide Vaccine used for?

Meningococcal ACWY Polysaccharide Vaccine is intended for the prevention of meningococcal meningitis and meningococcal infections. It targets disease caused by meningococcal serogroups A, C, W, and Y. The vaccine is being developed by Novartis AG and has completed a Phase 3 trial in healthy adults.

Who makes Meningococcal ACWY Polysaccharide Vaccine?

Meningococcal ACWY Polysaccharide Vaccine is developed by Novartis AG, which trades under the ticker NVS. Novartis conducted a Phase 3 study of the vaccine in Argentina and Colombia.

What phase is Meningococcal ACWY Polysaccharide Vaccine in?

Meningococcal ACWY Polysaccharide Vaccine is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The vaccine is investigational and has not been approved by the FDA.

What clinical trials is Meningococcal ACWY Polysaccharide Vaccine in?

Meningococcal ACWY Polysaccharide Vaccine has been evaluated in one completed Phase 3 clinical trial, NCT00474487. The study was titled "A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults" and enrolled 2,831 participants in Argentina and Colombia.

How was the Phase 3 trial of Meningococcal ACWY Polysaccharide Vaccine designed?

The Phase 3 trial NCT00474487 was a randomized, double-blind, active-controlled study. It enrolled 2,831 healthy adults aged 19 years and older of all sexes. The trial assessed safety and immune response and has been completed.