STN: BL 125549
Proper Name: Meningococcal Group B Vaccine
Trade Name: TRUMENBA
Manufacture: Wyeth Pharmaceuticals, Inc.
Indication:

• 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.

Product Information

• Package Insert - TRUMENBA

Supporting Documents

• November 19, 2021 Approval Letter - Trumenba
• March 14, 2018 Approval Letter - Trumenba
  To revise the package insert labeling to include additional information.
• January 10, 2018 Approval Letter - Trumenba
  To include information regarding an additional (single dose) syringe presentation.
• September 26, 2017 Approval Letter - Trumenba
  To revise the package insert.
• March 13, 2017 Summary Basis for Regulatory Action - Trumenba
• March 13, 2017 Approval Letter - Trumenba
  To include data from two confirmatory clinical studies to verify and describe the clinical benefit of the three-dose schedule (a dose administered at 0, 1-2, and 6 months) of Trumenba.
• Statistical Review of STN 125549/17 - TRUMENBA
• Addendum to Statistical Review of STN 125549/17
• Clinical Review of 125549/17 - TRUMENBA
• Clinical Review - TRUMENBA
• Statistical Review - TRUMENBA
• Approval History, Letters, Reviews, and Related Documents - TRUMENBA
• Supporting Documents older than three years - TRUMENBA

Related Information

• First vaccine approved by FDA to prevent serogroup B Meningococcal disease
• Trumenba (Serogroup B Meningococcal Vaccine) Questions and Answers