Recent Updates
Recently added Catalysts

Meningococcal Conjugate

Phase 3

Meningitis | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 5, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal Conjugate · 1 trial · 2 indications

Phase 3 1
NCT00901940Understanding the Immune Response to Meningitis VaccinesMeningitis
COMPLETED150 Analytics
PHASE3COMPLETED
Understanding the Immune Response to Meningitis Vaccines
MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint will be whether the SBA GMT at day 7 following MenACWY is ≥ 30% greater than that observed at day 7 following MenACWY PS.
Day 7

Secondary Endpoints

The measurement of meningococcal serogroup C SBAs (using human complement) at day 7 following the initial immunisation with MenACWY and MenACWY PS.
Day 7
The measurement of meningococcal serogroup A and C specific SBAs (using human complement) at day 28 following the initial immunisation with MenACWY and MenACWY PS, and at day 7 and day 28 following the 'follow up' immunisation with MenACWY.
Day 7-28
Meningococcal serogroup W-135 and Y SBAs will also be performed on a subset of samples obtained at the above timepoints.
Day 7-28
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
MenACWY Plain Polysaccharide (ACWY Vax)ACTIVE_COMPARATORThe MenACWY Plain Polysaccharide Vaccine, which is already licensed and is used as a travel vaccine, is known as the MenACWY plain polysaccharide (ACWY Vax). Participants in this arm will receive 1 dose of the MenACWY plain polysaccharide (ACWY Vax) and 1 dose of the MenACWY conjugate (MenACWY).
MenACWY conjugateACTIVE_COMPARATORThe MenACWY conjugate vaccine was licensed in the UK in March 2010, and is known as the MenACWY conjugate vaccine (Menveo). Participants in this arm will receive 2 doses of the MenACWY conjugate vaccine.

Interventions

NameTypeDescription
Meningococcal (Groups A, C, Y and W-135) ConjugateBIOLOGICAL2 x 0.5 mL dose
Meningococcal polysaccharide A, C, Y and W135 and MenveoBIOLOGICAL1 x 0.5 mL dose of ACWY Vax, 1 x 0.5 mL dose of Menveo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant is willing and able to give informed consent for participation after the nature of the study has been explained * Male or Female, aged 18- 70 years inclusive * In good health as determined by: * Medical history * History-directed physical examination * Clini...

Countries:United Kingdom
Unlock Eligibility Criteria

Frequently asked questions about Meningococcal Conjugate

What is Meningococcal Conjugate used for?

Meningococcal Conjugate is an investigational vaccine being developed for meningitis, a serious infection of the membranes surrounding the brain and spinal cord. It is also being studied in the context of septicemia, a related bloodstream infection. The drug is currently in Phase 3 clinical development.

Who makes Meningococcal Conjugate?

Meningococcal Conjugate is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the vaccine's safety and immune response in adults.

What phase is Meningococcal Conjugate in?

Meningococcal Conjugate is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under evaluation for the prevention of meningitis.

What clinical trials is Meningococcal Conjugate in?

Meningococcal Conjugate has one completed Phase 3 clinical trial registered as NCT00901940, titled 'Understanding the Immune Response to Meningitis Vaccines.' This trial enrolled 150 healthy adult volunteers in the United Kingdom and was actively controlled, meaning it compared the vaccine against an existing treatment.

How does Meningococcal Conjugate work?

Meningococcal Conjugate is a monoclonal antibody designed to target components of the bacteria that cause meningitis. By binding to specific bacterial targets, it helps the immune system recognize and fight the infection. This mechanism is intended to provide protection against meningococcal disease.