EFFICACY DATA

SHINGRIX demonstrated strong efficacy in immunocompromised patients ≥18 years of age.1

‌SHINGRIX Demonstrated 68.2% Efficacy Against Herpes Zoster in auHSCT Subjects (mTVC)1,*,†,‡

SHINGRIX vs Placebo
  SHINGRIX Placebo  
Age Group
(years)		 N/n N/n % Efficacy
(95% Cl)
Overall
(≥18)§		 870/49 851/135 68.2%
(55.5, 77.6)
18 to 49 213/9 212/29 71.8%
(38.7, 88.3)
≥50 657/40 639/106 67.3%
(52.6, 77.9)

* Median duration of follow-up period was 21 months (range: 0 to 49.4 months).

† mTVC=modified total vaccinated cohort, defined as subjects who received 2 doses (0 and 1 to 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of HZ within 1 month after the second dose. Follow-up was censored at the time of treatment for relapse.

‡ NCT01610414.

§ Primary study endpoint was based on confirmed HZ cases in subjects aged ≥18 years.

 

auHSCT=autologous hematopoietic stem cell transplant; Cl=confidence interval; HZ=herpes zoster; N=number of subjects in each group; n=number of subjects having at least 1 confirmed HZ episode.

SHINGRIX Also Demonstrated 89.3% Efficacy Against PHN in auHSCT Subjects ≥18 Years of Age (mTVC)1,2,*,†,‡

SHINGRIX vs Placebo
  SHINGRIX Placebo  

PHN

 N/n N/n % Efficacy (95% Cl)
  870/1 851/9 89.3%
(22.5, 99.8)

The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ1

 

 Data from a descriptive analysis.1

 

* NCT01610414.1

† Modified total vaccinated cohort, defined as subjects who received 2 doses (0 and 1 to 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of HZ within 1 month after the second dose. Follow-up was censored at the time of treatment for relapse.1

‡ Postherpetic neuralgia, defined as HZ-associated pain rated as a 3 or greater (on a 0- to 10-point scale) occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.1

 

auHSCT=autologous hematopoietic stem cell transplant; Cl=confidence interval; HZ=herpes zoster; N=number of subjects in each group; n=number of subjects having PHN; PHN=postherpetic neuralgia.

In Subjects With Hematologic Malignancies, SHINGRIX Demonstrated Strong Efficacy Against Shingles in a Post Hoc Analysis (mTVC)1,4,*,†, ‡

SHINGRIX vs Placebo
  SHINGRIX Placebo  
Age Group
(years)		 N/n N/n % Efficacy
(95% Cl)
Overall
(≥18)		 259/2 256/14 87.2%
(44.2, 98.6)

* Median duration of follow-up period was 11.1 months (range: 0-15.6 months).1

† Post hoc efficacy analysis was based on confirmed HZ cases in subjects aged ≥18 years.5

‡ mTVC=modified total vaccinated cohort, which included all participants from the total vaccinated cohort, except those who did not receive the second dose or who developed a confirmed case of HZ before 30 days after Dose 2.5

 

Cl=confidence interval; HZ=herpes zoster; N=number of subjects in group; n=number of subjects having at least 1 confirmed HZ episode.

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SAFETY INFO

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Learn about the incidence of shingles in immunocompromised patients aged 18 years and older.

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CDC Recommendations

See what CDC says about SHINGRIX. 

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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. Prescribing Information for SHINGRIX.

  2. Data on file. Study 115523 (NCT01610414). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=115523

  3. Bastidas A, de la Serna J, El ldrissi M, et al. JAMA. 2019;322(2):123-133.

  4. Data on file. Study 116428 (NCT01767467). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=116428

  5. Dagnew AF, llhan O, Lee WS, et al. Lancet Infect Dis. 2019:19(9):988-1000.

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