August 28, 2018 – Emerging clinical experience with vaccines against group B meningococcal disease “While recent data from the United Kingdom supports the potential for protein-based vaccines to provide direct protection against MenB disease in immunised children, further research is required to understand the breadth and duration of this protection. A more detailed understanding of the impact of immunisation with these vaccines on nasopharyngeal carriage of the meningococcus is also required, to inform both their potential to induce herd immunity and to preferentially select for carriage of strains not susceptible to vaccine-induced antibodies.

March 15 2018 – TRUMENBA Product Information – Supporting Documents

• • 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.
  • April 14, 2016 Approval Letters – TRUMENBA
    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
  • Addendum to Statistical Review of STN 125549/17
  • Clinical Review of 125549/17 – TRUMENBA
  • April 14, 2016 Summary Basis for Regulatory Action – TRUMENBA
  • December 9, 2014 Approval Letter – TRUMENBA
  • October 29, 2014 Approval Letter – TRUMENBA
  • October 29, 2014 Summay Basis for Regulatory Action – TRUMENBA
  • Clinical Review – TRUMENBA
  • Statistical Review – TRUMENBA
  • Approval History, Letters, Reviews, and Related Documents – TRUMENBA

Related Information

First vaccine approved by FDA to prevent serogroup B Meningococcal disease

Trumenba (Serogroup B Meningococcal Vaccine) Questions and Answers

March 2014 – UK poised to make decision on 4CMenB vaccine (full text) “In a letter to The Lancet shortly after the JCVI’s interim statement, Steve Black, a paediatrician based at Cincinatti Children’s Hospital in Ohio, USA, pointed to the failure of modelling to predict the cost effectiveness of several vaccines before their introduction in the USA. Novartis had placed great expectations on the UK, because the country has had a progressive meningitis C vaccination programme”, says Timo Vesikari, of the University of Tampere Medical School in Finland and a lead investigator on several clinical trials of 4CMenB. “The meningitis B problem in the UK is at least of the same magnitude as meningitis C was when the vaccination programme was started in 1999”, he continues. That programme, says Moxon, was introduced with no population-based efficacy study, no knowledge of herd immunity, and no economic analysis preceding its adoption for routine use. And yet, he contends, it has been “one of public health’s great success stories”.