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Also known as Novartis Meningococcal (MenACWY-CRM) vaccine
Novartis Meningococcal vaccine · 1 trial · 2 indications
Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
| Arm | Type | Description |
|---|---|---|
| I: MenACWY-CRM vaccine | EXPERIMENTAL | Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study. |
| II: Licensed Polysaccharide Meningococcal vaccine | EXPERIMENTAL | Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study. |
| III: Meningococcal Naive | EXPERIMENTAL | Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study. |
| Name | Type | Description |
|---|---|---|
| Novartis Meningococcal (MenACWY-CRM) vaccine | BIOLOGICAL | All subjects will have blood draws at Day 1, Day 8, and Day 29. |
Inclusion Criteria: * Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination. * Female subjects were to be negative for pregnancy Exclusion Criteria: * History of meningococcal disease * Receipt of any mening...
The Novartis Meningococcal vaccine, also known as MenACWY-CRM, is an investigational vaccine developed by Novartis AG for the prevention of meningococcal disease, including meningococcal meningitis. It is a vaccine candidate that has been studied in a Phase 2 clinical trial. It is not described as approved.
The Novartis Meningococcal vaccine is being studied for use against meningococcal disease, including meningococcal meningitis. Its clinical program has evaluated immune response and persistence of protection following a booster dose in healthy volunteers aged 16 years and older in the United States.
The Novartis Meningococcal vaccine is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program for this MenACWY-CRM vaccine candidate.
The Novartis Meningococcal vaccine is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The vaccine is investigational and is not described as FDA approved.
The Novartis Meningococcal vaccine has been studied in one completed Phase 2 trial, NCT01018732, titled A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY. That trial enrolled 155 healthy volunteers aged 16 years and older in the United States and used a controlled design.
Yes. The Novartis Meningococcal vaccine is also known as the Novartis Meningococcal (MenACWY-CRM) vaccine. MenACWY-CRM is the alternative name used for this Novartis AG vaccine candidate, so searches for either name refer to the same asset.