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Adjusted LOA
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No Vaccine · 1 trial · 2 indications
The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).
The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.
The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.
The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.
| Arm | Type | Description |
|---|---|---|
| rMenB06 | OTHER | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study had a blood draw. |
| rMenB0 | OTHER | Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study had a blood draw. |
| rMenB016 | OTHER | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study had a blood draw. |
| rMenB01 | OTHER | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 month) and placebo (at 2 and 6 months) in V72P10 study had a blood draw. |
| rMenB026 | OTHER | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study had a blood draw. |
| rMenB02 | OTHER | Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study had a blood draw. |
| rMenB012 | OTHER | Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and 1 dose of placebo (at 6 months) in V72P10 study had a blood draw. |
| rMenB6 | OTHER | Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study had a blood draw. |
| Naive | OTHER | An additional study group of naïve subjects that served as a baseline comparator for assessing antibody persistence in the vaccine groups and had blood draw for serological analyses at the time of enrollment. |
| Name | Type | Description |
|---|---|---|
| No Vaccine | BIOLOGICAL | - |
| rMenB+OMV-NZ | BIOLOGICAL | Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months). |
Inclusion Criteria: Informed consent was obtained from all the subjects before enrollment into the study after the nature of the study had been explained. Inclusion criteria for naive subjects, newly enrolled: 1. Healthy adolescents, 13-19 years of age (the age window is defined as the first day ...
No Vaccine is an investigational monoclonal antibody being studied for the prevention of meningococcal disease, including meningococcal meningitis. It is currently in Phase 2 clinical development and is not yet approved for any use.
No Vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.
No Vaccine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
No Vaccine has one completed Phase 2 clinical trial, identified as NCT01148524. This trial assessed antibody persistence at eighteen months after completion of a vaccination course and enrolled 817 participants in Chile.
Despite its name, No Vaccine is a monoclonal antibody, not a vaccine. It is being investigated for use in preventing meningococcal disease, which is caused by bacterial infection.