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Efficacy & Safety
How TRUMENBA Works
TRUMENBA targets a gene found in >99% of invasive MenB disease strains2
TRUMENBA works by targeting both subfamilies, A and B, of a lipoprotein—factor H binding protein (fHBP)—for which the gene is found in more than 99% of invasive MenB strains.2
The fHBP Discovery
Pfizer used a combined biochemical and immunological screening approach to identify surface-expressed proteins on MenB strains that were capable of producing antibodies that could kill diverse meningococcal strains. During this process, fHBP elicited robust bactericidal responses.1
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References:
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- Wang X, Cohn A, Comanducci M, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the United States. Vaccine. 2011;29(29-30):4739-4744.
- Jiang HQ, Hoiseth SK, Harris SL, et al. Broad vaccine coverage predicted for a bivalent recombinant factor H binding protein based vaccine to prevent serogroup B meningococcal disease. Vaccine. 2010;28(37):6086-6093.
- Tully J, Viner RM, Coen PG, et al. Risk and protective factors for meningococcal disease in adolescents: matched cohort study. BMJ. 2006;332(7539):445-450.
- Data on file. Pfizer Inc, New York, NY.
- Centers for Disease Control and Prevention. Meningococcal disease. Centers for Disease Control and Prevention website. http://www.cdc.gov/meningococcal/index.html. Updated January 21, 2020. Accessed July 6, 2020.
- Dwilow R, Fanella S. Invasive meningococcal disease in the 21st century—an update for the clinician. Curr Neurol Neurosci Rep. 2015;15(2):1-9.
- Ewald AJ, McKeag DB. Meningitis in the athlete. Curr Sports Med Rep. 2008;7(1):22-27.
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Why adolescents and young adults?
Typical adolescent and young adult behaviors increase MenB risk.4,6-8
Coadministration with TRUMENBA
TRUMENBA is the only MenB vaccine that demonstrated cross-coverage of diverse MenB strains1
Indication
- Trumenba is a vaccine 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
- The effectiveness of the two-dose schedule of Trumenba against diverse N meningitidis serogroup B strains has not been confirmed
- Severe allergic reaction after a previous dose of Trumenba is a contraindication
- Some individuals with altered immunocompetence may have reduced immune responses to Trumenba
- Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B even if they develop antibodies following vaccination with Trumenba
- As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients against N meningitidis serogroup B infections
- Syncope (fainting) can occur in association with administration of injectable vaccines, including Trumenba. Procedures should be in place to avoid injury from fainting
- In clinical studies, the most common solicited adverse reactions in adolescents and young adults were pain at injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%). Nausea was reported in up to 24% of adolescents in early phase studies
- Sufficient data are not available on the safety and effectiveness of using Trumenba and other meningococcal group B vaccines interchangeably to complete the vaccination series
- Safety and effectiveness have not been established in pregnant women
- Trumenba is a vaccine 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
- The effectiveness of the two-dose schedule of Trumenba against diverse N meningitidis serogroup B strains has not been confirmed
Please see full Prescribing Information.