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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).

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View reconstitution instructions for SHINGRIX.

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

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

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*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-70 and ZOE-50 trials from subjects randomized to receive 2 doses of SHINGRIX (N=7698 and 8250, respectively) or placebo (N=7713 and 8346, respectively). See study designs on Efficacy page for details. 1,2

CDC=Centers for Disease Control and Prevention; ZVL=zoster vaccine live; ACIP=Advisory Committee on Immunization Practices.

References:

  1. Prescribing Information for SHINGRIX.
  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. 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.

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

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