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Meningococcal serogroup B vaccine · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Meningococcal serogroup B vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination. * Female subjects must be of non-childbearing potential. Exclusion Criteria: * Previous vaccination against or history of meningococcal B or C, or hepatitis A diseas...
The meningococcal serogroup B vaccine is an investigational vaccine developed by GSK plc for preventing infections caused by Neisseria meningitidis serogroup B. It is designed to stimulate immune protection in healthy people, and it has been studied in adolescents aged 12 to 18 years in a Phase 2 clinical trial.
It is being developed for the prevention of meningococcal infections, specifically those caused by serogroup B bacteria. The vaccine is intended for healthy individuals, and the completed Phase 2 study evaluated it in adolescents aged 12 to 18 years using a three-dose schedule.
GSK plc, which trades under the ticker GSK, is the developer of this meningococcal serogroup B vaccine. The company sponsored the Phase 2 immunogenicity and safety study of the vaccine in healthy adolescents.
The meningococcal serogroup B vaccine is in Phase 2 development. One Phase 2 trial has been completed, and it enrolled 478 healthy adolescents aged 12 to 18 years. The vaccine is investigational and is not described as approved.
The vaccine has been studied in one completed Phase 2 trial, NCT00137917, titled Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs. It was a randomized, uncontrolled study that enrolled 478 participants.
The completed Phase 2 trial NCT00137917 evaluated the vaccine in healthy adolescents aged 12 to 18 years using a three-dose schedule. The study was randomized and enrolled 478 participants, and it assessed immunogenicity and safety. It was an uncontrolled study without a comparator arm.