Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01423084 | Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years | PHASE3 | COMPLETED | 344 | — | — | Aug 1, 2011 | Dec 1, 2011 | Feb 20, 2015 | 13 | Australia, Canada |
| NCT00297817 | Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents | PHASE2 | COMPLETED | 203 | — | — | Feb 1, 2006 | Apr 1, 2007 | Dec 1, 2016 | 8 | United States |
Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
| Arm | Type | Description |
|---|---|---|
| MenB Lot 1 | EXPERIMENTAL | MenB vaccine Lot 1: 2 doses administered 1 month apart |
| MenB Lot 2 | ACTIVE_COMPARATOR | MenB vaccine Lot 2: 2 doses administered 1 month apart |
| Arm 1: rMenB | EXPERIMENTAL | - |
| Arm 2: rMenB + OMV | EXPERIMENTAL | - |
| Arm 3: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Serogroup B meningococcal vaccine | BIOLOGICAL | All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2. A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination |
Inclusion Criteria: * Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment * who are available for all the visits scheduled in the study (i.e., not planning to l...