Scroll for Important Safety Information and Indication
IMPORTANT SAFETY INFORMATION
- 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
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
Please see full Prescribing Information.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc.; 2019.
- Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2020. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed July 6, 2020.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2020. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed July 6, 2020.
- MacNeil JR, Rubin L, Folaranmi T, et al. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR. 2015;64(41):1171-1176.
- QuintilesIMS primary market research study, 2017.
- Senders S, Bhuyan P, Jiang Q, et al. Immunogenicity, tolerability and safety in adolescents of bivalent rLP2086, a meningococcal serogroup B vaccine, coadministered with quadrivalent human papilloma virus vaccine. Pediatr Infect Disease J. 2016;35(5):548-554.
- Muse D, Christensen S, Bhuyan P, et al. A phase 2, randomized, active-controlled, observer-blinded study to assess the immunogenicity, tolerability, and safety of bivalent rLP2086, a meningococcal serogroup B vaccine, coadministered with tetanus, diphtheria and acellular pertussis vaccine and serogroup A, C, Y and W-135 meningococcal conjugate vaccine in healthy US adolescents. Pediatr Infect Dis J. 2016;35(6):673-682.
- 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.
- 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.
- 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.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- Soeters HM, McNamara LA, Whaley M, et al. Serogroup B meningococcal disease outbreak and carriage evaluation at a college—Rhode Island, 2015. MMWR. 2015;64(22):606-607.
- 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.
- Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403.
- Brandtzaeg P. Chapter 21: Pathogenesis and pathophysiology of invasive meningococcal disease. In: Frosch M, Maiden MCJ, eds. Handbook of Meningococcal Disease: Infection Biology, Vaccination, Clinical Management. Weinheim, Baden-Wurttemberg, Germany: Wiley-VCH; 2006:427-480.
- Van Deuren M, Brandtzaeg P, van der Meer JWM. Update on meningococcal disease with emphasis on pathogenesis and clinical management. Clin Microbiol Rev. 2000;13(1):144-166.
- MacNeil JR, Rubin L, Folaranmi T, et al. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR. 2015;64(41):1171-1176.
- Centers for Disease Control and Prevention. Enhanced meningococcal disease surveillance report, 2018. Centers for Disease Control and Prevention website. https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report-2018.pdf. Accessed July 22, 2020.
- Cohn A, MacNeil J. The changing epidemiology of meningococcal disease. Infect Dis Clin North Am. 2015;29(4):667-677.
- 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.
- 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.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2020. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed July 6, 2020.
- Centers for Disease Control and Prevention. Charter of the Advisory Committee on Immunization Practices. http://www.cdc.gov/vaccines/acip/committee/acip-charter-2016.pdf. Published April 2016. Accessed July 6, 2020.
- The Center for Consumer Information & Insurance Oversight. Affordable Care Act implementation FAQs-set 12. CMS.gov website. http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html. Accessed July 6, 2020.
- Folaranmi T, Rubin L, Martin SW, Patel M, MacNeil JR. Use of serogroup B meningococcal vaccines in persons aged ≥ 10 years at increased risk for serogroup B meningococcal disease: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(22):608-612.
- American Academy of Pediatrics. Recommendations for serogroup B meningococcal vaccine for persons 10 years and older. American Academy of Pediatrics website. http://pediatrics.aappublications.org/content/pediatrics/138/3/e20161890.full.pdf. Accessed July 6, 2020.
- Soeters HM, McNamara LA, Whaley M, et al. Serogroup B meningococcal disease outbreak and carriage evaluation at a college—Rhode Island, 2015. MMWR. 2015;64(22):606-607.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- 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.
- 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.
- 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.
- Soeters HM, McNamara LA, Whaley M, et al. Serogroup B meningococcal disease outbreak and carriage evaluation at a college—Rhode Island, 2015. MMWR. 2015;64(22):606-607.
- Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403.
- van Deuren M, Brandtzaeg P, van der Meer JWM. Update on meningococcal disease with emphasis on pathogenesis and clinical management. Clin Microbiol Rev. 2000;13(1):144-166.
- Brandtzaeg P. Chapter 21: Pathogenesis and pathophysiology of invasive meningococcal disease. In: Frosch M, Maiden MCJ, eds. Handbook of Meningococcal Disease: Infection Biology, Vaccination, Clinical Management. Weinheim, Germany; Wiley-VCH; 2006:427-480.
- Cohn AC, MacNeil JR, Harrison LH, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010;50(2):184-191.
- Bettinger JA, Scheifele DW, Le Saux N, et al. The disease burden of invasive meningococcal serogroup B disease in Canada. Pediatr Infect Dis J. 2013;32(1):e20-e25.
- Marshall GS, Dempsey AF, Srivastava A, Isturiz RE. US college students are at increased risk for serogroup B meningococcal disease. J Pediatric Infect Dis Soc. 2020;9(2):244-247. doi:10.1093/jpids/piz024.
- Folaranmi T, Rubin L, Martin SW, et al. Use of serogroup B meningococcoal vaccines in persons aged ≥10 years at increased risk for serogroup B meningococcal disease: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR. 2015;64(22):608-612.
- MacNeil N. Epidemiology and prevention of meningococcal disease in adolescents. Centers for Disease Control and Prevention. National Center for Immunization & Respiratory Diseases. Meningitis and Vaccine Preventable Disease Branch. http://health.mo.gov/living/wellness/immunizations/pdf/meningoccalvaccines71615.pdf. July 16, 2015. Accessed July 7, 2020.
- Centers for Disease Control and Prevention. Enhanced meningococcal disease surveillance report, 2018. Centers for Disease Control and Prevention website. https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report-2018.pdf. Accessed July 22, 2020.
- MacNeil JR, Rubin L, Folaranmi T, et al. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR. 2015;64(41):1171-1176.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- Vesikari T, Ostergaard L, Diez-Domingo J, et al. Meningococcal serogroup B bivalent rLP2086 vaccine elicits broad and robust serum bactericidal responses in healthy adolescents. J Pediatr Infect Dis Soc. 2015. Epub ahead of print: doi:10.1093/jpids/piv039.
- National Foundation for Infectious Disease. Addressing the challenges of serogroup B meningococcal disease outbreaks on campuses. http://www.nfid.org/wp-content/uploads/2019/08/meningococcal-b-report.pdf. Accessed July 22, 2020.
- Patton M, Stephens D, Moore K, et al. Centers for Disease Control and Prevention. Updated recommendations for use of MenB-FHbp serogroup B meningococcal vaccine—Advisory Committee on Immunization Practices, 2016. MMWR. 2017;66(19):509-513.
- Data on file. Clinical Study Report Protocol B1071033: Table 20. 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.
- 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.
- 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.
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.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- Soeters HM, McNamara LA, Whaley M, et al. Serogroup B meningococcal disease outbreak and carriage evaluation at a college—Rhode Island, 2015. MMWR. 2015;64(22):606-607.
- McNamara LA, Thomas JD, MacNeil J, et al. Meningococcal carriage following a vaccination campaign with MenB-4C and MenB-FHbp in response to a university serogroup B meningococcal disease outbreak—Oregon, 2015–2016. J Infect Dis. 2017;216(9):1130–1140.
- 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.
- 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.
- 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.
REFERENCE
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
REFERENCE
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- Data on file. Pfizer Inc, New York, NY.
- Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. https://www.cdc.gov/vaccines/acip/committee/acip-charter-2016.pdf. Published April 2016. Accessed July 6, 2020.
- Centers for Medicare and Medicaid Services (CMS). ICD-10_CM official guidelines for coding and reporting: FY 2020. CMS website. https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2020-Coding-Guidelines.pdf. Accessed July 9, 2020.
REFERENCES
- Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; 2019.
- Dorell C, Yankey D, Kennedy A, Stokley S. Factors that influence parental vaccination decisions for adolescents, 13 to 17 years old: National Immunization Survey-Teen, 2010. Clin Pediatr (Phila). 2013;52(2):162-170.
- Chapman GB, Li M, Leventhal H, Leventhal EA. Default clinic appointments promote influenza vaccination uptake without a displacement effect. Behav Sci Policy. 2016;2(2):41-50.