STN: BL 125549
Proper Name: Meningococcal Group B Vaccine
Trade Name: TRUMENBA
Manufacture: Wyeth Pharmaceuticals, Inc.
- Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age
April 14, 2016 Approval Letter - TRUMENBA(PDF - 61KB)
To include a two-dose schedule (a dose administered at 0 and 6 months) according to the regulations for accelerated approval and a modification of the three-dose schedule from administration at 0, 2, and 6 months to administration at 0, 1-2, and 6 months.
Statistical Review of STN 125549/17 - TRUMENBA(PDF - 479KB) Addendum to Statistical Review of STN 125549/17(PDF - 57KB) Clinical Review of 125549/17 - TRUMENBA(PDF - 474KB) April 14, 2016 Summary Basis for Regulatory Action - TRUMENBA(PDF - 116KB) December 9, 2014 Approval Letter - TRUMENBA October 29, 2014 Approval Letter - TRUMENBA October 29, 2014 Summay Basis for Regulatory Action - TRUMENBA(PDF - 176KB) Approval History, Letters, Reviews, and Related Documents - TRUMENBA[ARCHIVED]