IMMUNOGENICITY DATA OVERVIEW

Evaluated in clinical trials in immunocompromised patients ≥18 years of age, representing groups at high risk for herpes zoster.1-10

Review immunogenicity data in post-autologous hematopoietic stem cell transplant (auHSCT) patients aged 18 years and older.

See Post-auHSCT Data

Review immunogenicity data in patients aged 18 years and older with hematologic malignancies.

See Hematologic Malignancy Data

Review immunogenicity data in post-renal transplant patients aged 18 years and older.

See Post-Renal Transplant Data

Review immunogenicity data in patients aged 18 years and older with solid tumors.

See Solid Tumor Malignancy Data

Review immunogenicity data in patients aged 18 years and older with HIV.

See HIV Data

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Safety Profile

Learn about the safety profile of SHINGRIX in immunocompromised patients aged 18 years and older.

SAFETY INFO

CDC Recommendations

See what CDC says about SHINGRIX. 

LEARN MORE

Storage & Dosing

Learn how to store and properly dose SHINGRIX.

SEE HOW

Indication & Important Safety Info

Indication

Important Safety Information

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

  • in adults aged 50 years and older.
  • in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

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
  • Syncope (fainting) can be associated with the administration of injectable vaccines, including SHINGRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Solicited local adverse reactions reported in individuals aged 50 years and older were pain (78%), redness (38%), and swelling (26%)
  • Solicited general adverse reactions reported in individuals aged 50 years and older were myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and gastrointestinal symptoms (17%)  
  • Solicited local adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were pain (88% and 83%), redness (30% and 35%), and swelling (21% and 18%)  
  • Solicited general adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were fatigue (64% and 54%), myalgia (58% and 52%), headache (44% and 30%), gastrointestinal symptoms (21% and 28%), shivering (31% and 25%), and fever (28% and 18%)
  • The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women
  • It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

 

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at https://gsk.public.reportum.com or
1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

References

  1. Data on file. Study 115523 (NCT01610414). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=115523
  2. Bastidas A, de la Serna J, El ldrissi M, et al. JAMA. 2019;322(2):123-133.
  3. Dagnew AF, llhan O, Lee WS, et al. Lancet Infect Dis. 2019;19(9):988-1000.
  4. Data on file. Study 116428 (NCT01767467). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=116428
  5. Data on file. Study 116886 (NCT02058589). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=116886
  6. Vink P, Ramon Torrell JM, Sanchez Fructuoso A, et al. Clin Infect Dis. 2020;70(2):181-190.
  7. Data on file. Study 116427 (NCT01798056). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=116427
  8. Vink P, Mingorance ID, Alonso CM, et al. Cancer. 2019;125(8):1301-1312.
  9. Berkowitz EM, Moyle G, Stellbrink HJ. J Infect Dis. 2015;211:1279-1287.
  10. Data on file. Study 112673 (NCT01165203). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=112673

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