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meningococcal B rLP2086 vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | dose level 1 rLP2086 vaccine |
| 2 | EXPERIMENTAL | dose level 2 rLP2086 vaccine |
| 3 | EXPERIMENTAL | dose level 3 rLP2086 vaccine |
| 4 | PLACEBO_COMPARATOR | normal saline (placebo) |
| Name | Type | Description |
|---|---|---|
| meningococcal B rLP2086 vaccine. | BIOLOGICAL | vaccine, 0.5 mL, 0 - 2 - 6 to 9 months |
| normal saline (placebo) | OTHER | vaccine, 0.5 mL, 0 - 2 - 6 to 9 months |
Inclusion Criteria: * Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment. * Negative urine pregnancy test for all female subjects. * Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant...
The meningococcal B rLP2086 vaccine is an investigational vaccine developed by Pfizer for the prevention of meningitis caused by serogroup B meningococcal bacteria. It is a recombinant lipidated protein vaccine studied in healthy adolescents. It is not an approved product and remains in clinical development.
The meningococcal B rLP2086 vaccine is being studied for the prevention of meningococcal meningitis, specifically disease caused by serogroup B Neisseria meningitidis. Its clinical program has focused on healthy adolescents aged 11 years and older. It is investigational and has not been approved for use.
Pfizer, Inc. is the developer of the meningococcal B rLP2086 vaccine. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company sponsored the Phase 2 study of the vaccine in adolescents.
The meningococcal B rLP2086 vaccine is in Phase 2 development. Its single recorded trial, NCT00808028, was a Phase 2 study that has been completed. No active trials are currently listed, and the vaccine is not approved.
The meningococcal B rLP2086 vaccine has been evaluated in one completed Phase 2 trial, NCT00808028, titled A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents. That randomized, placebo-controlled study enrolled 538 healthy adolescents in Australia, Poland, and Spain.
The meningococcal B rLP2086 vaccine is also referred to simply as meningococcal B rLP2086 vaccine. It is a distinct Pfizer investigational candidate and should not be confused with other serogroup B meningococcal vaccines developed by different manufacturers.