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The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: rMenB | Experimental |
| |
| Arm 2: rMenB + OMV | Experimental |
| |
| Arm 3: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serogroup B meningococcal vaccine | Biological | 0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents | 1 month after completion of immunization schedule |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents | 6 months after completion of immunization schedule |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines - Drug Information Services | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encinitas | California | 92024 | United States | |||
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| serogroup B meningococcal vaccine | Biological | 0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. |
|
| serogroup B meningococcal vaccine | Biological | 0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule. |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| St Louis | Missouri | 63110 | United States |
| Cleveland | Ohio | 44118 | United States |
| Galveston | Texas | 77555 | United States |
| Layton | Utah | 84123 | United States |
| Salt Lake City | Utah | 84121 | United States |
| Seattle | Washington | 98101 | United States |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
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