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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...
Novartis Meningococcal vaccine is an investigational vaccine being studied for the prevention of Meningococcal Disease, including Meningococcal Meningitis. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Novartis Meningococcal vaccine is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Basel, Switzerland. The company trades on the New York Stock Exchange under the ticker symbol NVS.
Novartis Meningococcal vaccine is currently in Phase 2 clinical development. It is an investigational product, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials for safety and efficacy.
Novartis Meningococcal vaccine has been studied in one completed Phase 2 clinical trial, identified as NCT01018732. This trial, titled 'A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY,' enrolled 155 participants aged 16 years and older in the United States.
Novartis Meningococcal vaccine is classified as a monoclonal antibody modality, though it is being developed as a vaccine for Meningococcal Disease. The Phase 2 trial NCT01018732 was a controlled study that did not use randomization or double-blind design.