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DEMONSTRATED SAFETY PROFILE IN MORE THAN 3,000 PATIENTS ACROSS 4 CLINICAL TRIALS OVERALL1

Subjects in United States/Poland trial (10 through 25 years of age) with adverse events1,*
  DOSE 1: DOSE 2:
 

BEXSERO

(N=110-114)

SALINE PLACEBO

(N=94-96)

BEXSERO

(N=107-109)

MENVEO

(N=90-92)

Local Adverse Reactions
Pain - Any (Severe) 90% (20%)
27% (2%) 83% (29%)
43% (8%)
Erythema: Any (≥1 mm) 50%
13% 45%
26%
   >100 mm 0%
0% 0%
2%
Induration: Any (≥1 mm) 32%
10% 28%
23%
   >100 mm 0%
0% 0%
2%
Systemic Adverse Reactions Any (Severe)
Any (Severe)
Fatigue 37% (4%)
22% (0%) 35% (6%)
20% (2%)
Nausea 19% (4%)
4% (0%) 18% (4%)
4% (0%)
Myalgia 49% (12%)
26% (1%) 48% (13%)
25% (4%)
Arthralgia 13% (2%)
4% (0%) 16% (2%)
4% (0%)
Headache 33% (4%)
20% (1%) 34% (6%)
23% (3%)
Fever (≥38°C) 1%
1% 5%
0%

Severe=unable to perform normal daily activity.

* The United States/Poland trial was a randomized, controlled study. 120 participants 10 through 25 years of age received at least 1 dose of BEXSERO, including 112 participants who received 2 doses of BEXSERO 2 months apart. 97 participants received saline placebo followed by MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine).1

Administered 2 months after dose 1.

Solicited events in 3 other clinical trials among participants 11 through 24 years of age who received BEXSERO were comparable to the US/Poland trial, with the exception of severe myalgia (3%-7%) and severe pain in the United Kingdom trial (8%).1


Additional prelicensure safety experience1

In additional prelicensure safety experience, in response to outbreaks of serogroup B meningococcal disease at 2 universities in the US, BEXSERO was administered as a 2-dose series at least 1 month apart. Information on serious adverse events was collected for a period of 30 days after each dose from 15,351 individuals 16 through 65 years of age who received at least 1 dose. Overall 50 individuals (0.3%) reported serious adverse events, including one event considered related to vaccination, a case of anaphylaxis within 30 minutes following vaccination.1

 

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.

References

  1. Prescribing Information for BEXSERO.
  2. Prescribing Information for TRUMENBA.
  3. 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.
  4. Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011;11(7):969-985.
  5. Ellis TN, Kuehn MJ. Virulence and immunomodulatory roles of bacterial outer membrane vesicles. Microbiol Mol Biol Rev. 2010;74(1):81-94.
  6. Biagini M, Spinsanti M, De Angelis G, et al. Expression of factor H binding protein in meningococcal strains can vary at least 15-fold and is genetically determined. Proc Natl Acad Sci USA. 2016;113(10):2714-2719.
  7. Vogel U, Taha M-K, Vazquez JA, et al. Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment. Lancet Infect Dis. 2013;13(5):416-425.
  8. Data on file, GSK.
  9. Pelton SI. Meningococcal disease awareness: clinical and epidemiological factors affecting prevention and management in adolescents. J Adolesc Health. 2010;46:S9-S15.
  10. MacNeil J, Cohn A. Meningococcal disease. In: Roush SW, Baldy LM, eds. Manual for the Surveillance of Vaccine-Preventable Diseases. 5th ed. Atlanta, GA: Centers for Disease Control and Prevention; 2011. www.cdc.gov/vaccines/pubs/surv-manual/chpt08-mening.pdf. Accessed February 18, 2019.
  11. Meningococcal vaccination: what everyone should know. Centers for Disease Control and Prevention website: https://www.cdc.gov/vaccines/vpd/mening/hcp/adolescent-vaccine.html. Last Update May 19, 2017. Accessed April 25, 2019.
  12. Meningococcal disease. In: Hamborsky J, Kroger A, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:231-245. www.cdc.gov/vaccines/pubs/pinkbook/mening.html. Accessed February 18, 2019.
  13. Slack R, Hawkins KC, Gilhooley L, Addison GM, Lewis MA, Webb NJA. Long-term outcome of meningococcal sepsis-associated acute renal failure. Pediatr Crit Care Med. 2005;6(4):477-479.
  14. Vyse A, Anonychuk A, Jäkel A, Wieffer H, Nadel S. The burden and impact of severe and long-term sequelae of meningococcal disease. Expert Rev Anti Infect Ther. 2013;11(6):597-604.
  15. Centers for Disease Control and Prevention website. Enhanced Meningococcal Disease Surveillance Reports, 2015-2017. www.cdc.gov/meningococcal/surveillance/index.html#enhanced-reports. Updated March 28, 2017. Accessed April 1, 2019.
  16. MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M, Martin SW. 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.

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.

Important Safety Information

  • BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%)
  • Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains
  • Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO
  • Vaccination with BEXSERO may not result in protection in all vaccine recipients

Please see full Prescribing Information for BEXSERO.

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