UNIQUELY DESIGNED TO OVERCOME AGE-RELATED DECLINE IN SHINGLES IMMUNITY1-3

 

The 2-dose series of the recombinant, antigen/Adjuvant System formulation stimulates the immune system to generate a strong and sustained immune response.2,3

SHINGRIX Antigen and Adjuvant Systems Image

Aging Immune System Image Immune Response with SHINGRIX Image

VZV=varicella zoster virus.

MECHANISM OF ACTION VIDEO

See how SHINGRIX helps address age-related decline in shingles immunity.


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

References: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007;356(13):1338-1343. 7. 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. 8. Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol. 2012;24(4):494-500. 9. 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. 10. 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.

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1004182R0 April 2018