Recent Updates
Recently added Catalysts

Meningococcal ACWY Polysaccharide Vaccine

Phase 3

Meningococcal Meningitis | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 21, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment2,831

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Meningococcal ACWY Polysaccharide Vaccine

What is Meningococcal ACWY Polysaccharide Vaccine used for?

Meningococcal ACWY Polysaccharide Vaccine is used for the prevention of meningococcal meningitis and meningococcal infections. It is an investigational vaccine being developed by Novartis AG for use in healthy adults. The vaccine is designed to provide immune response against the ACWY serogroups of the meningococcal bacteria.

Who makes Meningococcal ACWY Polysaccharide Vaccine?

Meningococcal ACWY Polysaccharide Vaccine is being developed by Novartis AG, a multinational pharmaceutical company. The company's stock is traded under the ticker symbol NVS. The vaccine is currently in Phase 3 clinical development for the prevention of meningococcal meningitis.

What phase is Meningococcal ACWY Polysaccharide Vaccine in?

Meningococcal ACWY Polysaccharide Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine is being studied for its safety and immune response in healthy adults.

What clinical trials is Meningococcal ACWY Polysaccharide Vaccine in?

Meningococcal ACWY Polysaccharide Vaccine has one completed Phase 3 clinical trial with the identifier NCT00474487. The trial, titled 'A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults,' enrolled 2,831 participants in Argentina and Colombia. The study was randomized, double-blind, and active-controlled.

How does Meningococcal ACWY Polysaccharide Vaccine work?

Meningococcal ACWY Polysaccharide Vaccine is a polysaccharide vaccine that works by stimulating the immune system to produce antibodies against the A, C, W, and Y serogroups of Neisseria meningitidis, the bacteria that cause meningococcal meningitis. This immune response helps protect against meningococcal infections.

Is Meningococcal ACWY Polysaccharide Vaccine the same as MenACWY?

Meningococcal ACWY Polysaccharide Vaccine is a vaccine targeting the same serogroups as other MenACWY vaccines, but it is a distinct investigational product developed by Novartis AG. It is not the same as other commercially available MenACWY vaccines, as it is still in clinical development and has not been approved.