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Video Center

About SHINGRIX

Pivotal Trials

Learn about the pivotal clinical trials from Professor Tony Cunningham, one of the principal investigators and authors of the articles on our clinical trials published in the New England Journal of Medicine.

Pivotal Trials Synopsis

A brief review of the key elements from the pivotal clinical trials.
 

Reconstitution

Review reconstitution instructions for SHINGRIX.
 

Mechanism of Action

View how SHINGRIX is uniquely formulated to overcome age-related decline in shingles immunity.
 

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Webinars

Attend an information-filled webinar on topics like implementing SHINGRIX, series completion, payer access, and storage and administration.

Resources

Our library of resources includes handouts for patients, plus pocket and reference guides for you and your staff.

Efficacy

Only SHINGRIX delivered >90% efficacy against shingles regardless of age in those 50 years and older.1,*

 

  •   *Data from the phase 3 ZOE-50 (≥50 years of age) trial and pooled data in individuals ≥70 years of age from the phase 3 ZOE-50 and ZOE-70 trials from subjects who received 2 doses of SHINGRIX (N=7344 and 8250, respectively) or placebo (N=7415 and 8346, respectively) and did not develop a confirmed case of herpes zoster within 1 month after the second dose. See study designs on Efficacy page for more details.1

References: 1. Prescribing Information for SHINGRIX.

  • See Video References

    References for Pivotal Trials Video: 1. Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008;57(RR-5):1-30. 2. Chlibek R, Smetana J, Pauksens K, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745-1753. 3. Cunningham AL, Dworkin RH. The management of post-herpetic neuralgia. BMJ. 2000;321(7264):778-779. 4. Cunningham AL, Lal H, Kovac M, et al, for the ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-1032. 5. Kilgore PE, Kruszon-Moran D, Seward JF, et al. Varicella in Americans from NHANES III: implications for control through routine immunization. J Med Virol. 2003;70(suppl 1):S111-S118. 6. Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096. 7. Leroux-Roels G, Marchant A, Levy J, et al. Impact of adjuvants on CD4+ T cell and B cell responses to a protein antigen vaccine: results from a phase II, randomized, multicenter trial. Clin Immunol. 2016;169:16-27. 8. Malavige GN, Jones L, Black AP, Ogg GS. Varicella zoster virus glycoprotein E-specific CD4+ T cells show evidence of recent activation and effector differentiation, consistent with frequent exposure to replicative cycle antigens in healthy immune donors. Clin Exp Immunol. 2008;152(3):522-531. 9. NEJM Group. Notable Articles of 2016: A Collection of Important Studies From the Past Year as Selected by NEJM Editors. Waltham, MA: Massachusetts Medical Society; 2016. 10. Oxman MN, Levin MJ, Johnson GR, et al, for the Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005;352(22):2271-2284. 11. Schmader K. Herpes zoster in older adults. Clin Infect Dis. 2001;32(10):1481-1486. 12. Prescribing Information for SHINGRIX.

    References for Pivotal Trials Synopsis Video: 1. Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096. 2. Cunningham AL, Lal H Kovac M, et al, for the ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-1032. 3. Chlibek R, Smetana J, Pauksens K, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745-1753. 4. Prescribing Information for SHINGRIX.

    References for Mechanism of Action Video: 1. Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008;57(RR-5):1-30. 2. Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007;356(13):1338-1343. 3. Tseng HF, Harpaz R, Luo Y, et al. Declining effectiveness of herpes zoster vaccine in adults aged ≥60 years. J Infect Dis. 2016;213(12):1872-1875. 4. Chlibek R, Smetana J, Pauksens K, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745-1753. 5. Prescribing Information for SHINGRIX. 6. Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096. 7. Cunningham AL, Lal H, Kovac M, et al, for the ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-1032. 8. Dendouga N, Fochesato M, Lockman L, Mossman S, Giannini SL. Cell-mediated immune responses to a varicella-zoster virus glycoprotein E vaccine using both a TLR agonist and QS21 in mice. Vaccine. 2012;30(20):3126-3135. 9. Chlibek R, Pauskens K, Rombo L, et al. Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults. Vaccine. 2016;34(6):863-868.

    Reference for Reconstitution Video: 1. Prescribing Information for SHINGRIX.

    References for the Implementing SHINGRIX Video: 1. Kilgore PE, Kruszon-Moran D, Seward JF, et al. Varicella in Americans from NHANES III: implications for control through routine immunization. J Med Virol. 2003;70(suppl 1):S111-S118. 2. Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008;57(RR-5):1-30. 3. Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014;4(6):e004833. 4. Prescribing Information for SHINGRIX. 5. Yawn BP, Saddier P, Wollan PC, St. Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc. 2007;82(11):1341-1349. 6. Chlibek R, Smetana J, Pauksens K, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745-1753. 7. Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096. 8. Bharucha T, Ming D, Breuer J. A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Hum Vaccin Immunother. 2017;13(8):1789-1797. 9. Dendouga N, Fochesato M, Lockman L, Mossman S, Giannini SL. Cell-mediated immune responses to a varicella-zoster virus glycoprotein E vaccine using both a TLR agonist and QS21 in mice. Vaccine. 2012;30(20):3126-3135. 10. Leroux-Roels G, Marchant A, Levy J, et al. Impact of adjuvants on CD4+ T cell and B cell responses to a protein antigen vaccine: results from a phase II, randomized, multicenter trial. Clin Immunol. 2016;169:16-27. 11. Data on file, GSK. 12. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. MMWR. 2018;67(3):103-108. 13. Grupping K, Campora L, Douha M, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live attenuated herpes zoster vaccine. J Infect Dis. 2017;216(11):1343-1351. 14. Centers for Disease Control and Prevention. Frequently Asked Questions About Shingrix. https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/faqs.html. Updated August 22, 2018. Accessed January 23, 2019. 15. Lal H, Poder A, Campora L, et al. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: results of a phase III, randomized, open-label, multicenter study. Vaccine. 2018;36(1):148-154.

    References for the SHINGRIX Overview Video: 1. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. MMWR. 2018;67(3):103-108. 2. Centers for Disease Control and Prevention. Immunization Works Newsletter—October 2017. https://www.cdc.gov/vaccines/news/newsltrs/imwrks/2017/2017-10.html. Accessed March 14, 2018. 3. Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008;57(RR-5):1-30. 4. Chlibek R, Smetana J, Pauksens K, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745-1753. 5. Cunningham AL, Lal H, Kovac M, et al, for the ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-1032. 6. Grupping K, Campora L, Douha M, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live attenuated herpes zoster vaccine. J Infect Dis. 2017;216(11):1343-1351. 7. Kilgore PE, Kruszon-Moran D, Seward JF, et al. Varicella in Americans from NHANES III: implications for control through routine immunization. J Med Virol. 2003;70(suppl 1):S111-S118. 8. Kimberlin DW, Whitley RJ. Varicella–zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007;356(13):1338-1343. 9. Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096. 10. Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol. 2012;24(4):494-500. 11. Patterson-Bartlett J, Levin MJ, Lang N, Schödel FP, Vessey R, Weinberg A. Phenotypic and functional characterization of ex vivo T cell responses to the live attenuated herpes zoster vaccine. Vaccine. 2007;25(41):7087-7093. 12. Prescribing Information for SHINGRIX. 13. Schmader K. Herpes zoster in older adults. Clin Infect Dis. 2001;32(10):1481-1486. 14. Weinberg A, Lazar AA, Zerbe GO, et al. Influence of age and nature of primary infection on varicella-zoster virus—specific cell-mediated immune responses. J Infect Dis. 2010;201(7):1024-1030. 15. Yawn BP, Saddier P, Wollan PC, St. Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc. 2007;82(11):1341-1349.

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

  • SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
  • Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX
  • In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX
  • Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%)
  • Solicited general adverse reactions in subjects aged 50 years and older were myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), and gastrointestinal symptoms (17.3%)
  • SHINGRIX was not studied in pregnant or lactating women, and it is unknown if it is excreted in human milk. Therefore, it cannot be established whether there is vaccine-associated risk with SHINGRIX in pregnant women or if there are effects on breastfed infants or milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

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