VIDEO CENTER

 

ABOUT SHINGRIX

PIVOTAL TRIALS VIDEO

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. Learn why the ZOE-70 study was included in “Notable Articles of 2016,” a special New England Journal of Medicine publication highlighting articles that the editors deemed “the most meaningful in improving medical practice and patient care.”

PIVOTAL TRIALS SYNOPSIS VIDEO

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

MECHANISM OF ACTION VIDEO

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

  RECONSTITUTION VIDEO

  View reconstitution instructions for SHINGRIX.


 ON-DEMAND EDUCATION

To view these on-demand videos, please use your GSKSource account when prompted. Creating a GSKSource account is the easiest way to view on-demand education and receive updates from GSK. If you do not already have an account, you will be prompted to create one before you can watch the on-demand professional educational videos.

2017 SHINGRIX NATIONAL BROADCAST EVENT

On November 30, 2017, Dr. Romulo Colindres, VP, Global Medical Affairs Lead, Zoster, GSK, delivered a National Broadcast. In his presentation, Dr. Colindres discusses zoster disease, the current prevention and treatment options, ACIP recommendations, and the clinical profile of SHINGRIX.

MEDICAL SCIENCE LIAISON PRESENTATION ON SHINGRIX

Tiffany Mond, GSK Medical Science Liaison, presents information about zoster disease, ACIP recommendations, and the clinical profile of SHINGRIX.


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
  • 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
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, for the ZOE-70 Study Group. 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 Synposis 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: Prescribing Information for SHINGRIX.

References for the 2017 SHINGRIX National Broadcast Event Video: 1. American Association of Retired Persons. Getting To Know Americans Age 50+. https://www.aarp.org/content/dam/aarp/research/surveys_statistics/general/2014/getting-to-know-americans-age-50-plus-demographics.doi.10.26419%252Fres.00091.001.pdf. Accessed March 19, 2018. 2. 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. 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. 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. 5. 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. 6. Schmader K. Herpes zoster in older adults. Clin Infect Dis. 2001;32(10):1481-1486. 7. 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. 8. Prescribing Information for SHINGRIX. 9. Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007;356(13):1338-1343. 10. Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol. 2012;24(4):494-500. 11. 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. 12. 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. 13. 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. 14. 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. 15. 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. 16. 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. 17. 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.

References for the Medical Science Liaison Presentation on SHINGRIX 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.

All trademarks are the property of their respective owners.

1002806R0 March 2018