SAFETY PROFILE

Safety was evaluated in 6 studies in 5 different immunocompromised populations aged 18 years and older.

Data from the largest of the 6 studies

Solicited Local and General Adverse Reactions Within 7 Days of Vaccination in auHSCT Recipients Aged 18-49 Years*,†

  Adverse Reactions Dose 1 Adverse Reactions Dose 2
  All Grades/Grade 3‡,§ All Grades/Grade 3‡,§
  SHINGRIX % Placebo∥ % SHINGRIX % Placebo∥ %
Local Adverse Reactions n=223 n=217 n=205 n=207
Pain 81/11 8/1 82/11 6/0
Redness 20/1 0/0 25/2 0/0
Swelling 14/0 0/0 17/2 0/0
General Adverse Reactions n=222 n=218 n=203 n=207
Myalgia 41/4 22/2 51/8 21/2
Fatigue 49/6 34/1 51/10 25/2
Headache 23/1 17/0 38/5 17/2
Shivering 20/1 12/0 26/6 6/0
Fever 9/0 4/0 28/1 2/0
GI# 14/1 13/0 13/1 12/1

Data from the largest of the 6 studies

Solicited Local and General Adverse Reactions Within 7 Days of Vaccination in auHSCT Recipients Aged 18-49 Years*,†
Adverse Reactions Dose 1
All Grades/Grade 3‡,§
  SHINGRIX % Placebo∥ %
Local Adverse Reactions n=223 n=217
Pain 81/11 8/1
Redness 20/1 0/0
Swelling 14/0 0/0
General Adverse Reactions n=222 n=218
Myalgia 41/4 22/2
Fatigue 49/6 34/1
Headache 23/1 17/0
Shivering 20/1 12/0
Fever 9/0 4/0
GI# 14/1 13/0
Adverse Reactions Dose 2
All Grades/Grade 3‡,§
  SHINGRIX % Placebo∥ %
Local Adverse Reactions n=205 n=207
Pain 82/11 6/0
Redness 25/2 0/0
Swelling 17/2 0/0
General Adverse Reactions n=203 n=207
Myalgia 51/8 21/2
Fatigue 51/10 25/2
Headache 38/5 17/2
Shivering 26/6 6/0
Fever 28/1 2/0
GI# 13/1 12/1
  • Total vaccinated cohort (TVC) for safety included all subjects with at least 1 documented dose (n)
  • %=Percentage of subjects reporting the symptom at least once
  • *

    Seven days included day of vaccination and the subsequent 6 days.

  • †

    NCT01610414.

  • ‡

    Grade 3 pain: defined as significant pain at rest preventing normal everyday activities; Grade 3 redness and swelling are defined as >100 mm in size.

  • §

    Grade 3 myalgia, fatigue, headache, shivering, and GI: defined as preventing normal activity.

  • ‖

    Placebo was sucrose reconstituted with saline solution.

  • Fever: defined as temperature ≥37.5°C (99.5°F). Grade 3 fever: defined as temperature >39.5°C (103.1°F).

  • #

    GI=gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.

  •  
  •  

     auHSCT=autologous hematopoietic stem cell transplant.

In general, the reported frequencies of solicited local and general adverse reactions in the other studies in immunocompromised populations were similar to that of the autologous hematopoietic stem cell transplant study.

Data from the largest of the 6 studies

Solicited Local and General Adverse Reactions Within 7 Days of Vaccination in auHSCT Recipients ≥50 Years*,†

  Adverse Reactions Dose 1 Adverse Reactions Dose 2
  All Grades/Grade 3‡,§ All Grades/Grade 3‡,§
  SHINGRIX % Placebo∥ % SHINGRIX % Placebo∥ %
Local Adverse Reactions n=673 n=673 n=635 n=627
Pain 75/5 6/0.3 74/7 5/0
Redness 21/1 1/0 28/3 1/0
Swelling 10/0.1 1/0 15/1 1/0
General Adverse Reactions n=674 n=674 n=633 n=628
Myalgia 37/2 18/1 43/4 17/1
Fatigue 37/3 31/2 46/4 26/3
Headache 15/0.1 13/0.4 25/2 8/1
Shivering 11/0.4 7/1 21/3 7/0.2
Fever 6/0.1 3/0 15/0.2 4/0.2
GI# 18/1 16/1 18/2 12/2

Data from the largest of the 6 studies

Solicited Local and General Adverse Reactions Within 7 Days of Vaccination in auHSCT Recipients ≥50 Years*,†
Adverse Reactions Dose 1
All Grades/Grade 3‡,§
  SHINGRIX % Placebo∥ %
Local Adverse Reactions n=673 n=673
Pain 75/5 6/0.3
Redness 21/1 1/0
Swelling 10/0.1 1/0
General Adverse Reactions n=674 n=674
Myalgia 37/2 18/1
Fatigue 37/3 31/2
Headache 15/0.1 13/0.4
Shivering 11/0.4 7/1
Fever 6/0.1 3/0
GI# 18/1 16/1
Adverse Reactions Dose 2
All Grades/Grade 3‡,§
  SHINGRIX % Placebo∥ %
Local Adverse Reactions n=635 n=627
Pain 74/7 5/0
Redness 28/3 1/0
Swelling 15/1 1/0
General Adverse Reactions n=633 n=628
Myalgia 43/4 17/1
Fatigue 46/4 26/3
Headache 25/2 8/1
Shivering 21/3 7/0.2
Fever 15/0.2 4/0.2
GI# 18/2 12/2
  • Total vaccinated cohort (TVC) for safety included all subjects with at least 1 documented dose (n)
  • %=Percentage of subjects reporting the symptom at least once
  • *

    Seven days included day of vaccination and the subsequent 6 days.

  • †

    NCT01610414.

  • ‡

    Grade 3 pain: defined as significant pain at rest preventing normal everyday activities; Grade 3 redness and swelling are defined as >100 mm in size.

  • §

    Grade 3 myalgia, fatigue, headache, shivering, and GI: defined as preventing normal activity.

  • ‖

    Placebo was sucrose reconstituted with saline solution.

  • Fever: defined as temperature ≥37.5°C (99.5°F). Grade 3 fever: defined as temperature >39.5°C (103.1°F).

  • #

    GI=gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.

  •  
  •  

     auHSCT=autologous hematopoietic stem cell transplant.

In general, the reported frequencies of solicited local and general adverse reactions in the other studies in immunocompromised populations were similar to that of the autologous hematopoietic stem cell transplant study.

Additional Safety Information: Unsolicited Adverse Events, Serious Adverse Events, Deaths, and Potential Immune-Mediated Diseases Across 6 Trials of Immunocompromised Adults (TVC*)

  Within 30 days following each vaccination
  SHINGRIX Placebo
Unsolicited AEs (serious and nonserious)† 46% 44%

Additional Safety Information: Unsolicited Adverse Events, Serious Adverse Events, Deaths, and Potential Immune-Mediated Diseases Across 6 Trials of Immunocompromised Adults (TVC*)

  From first administered dose up to 30 days post-last vaccination From first administered dose up to 1 year post-last vaccination
  SHINGRIX Placebo SHINGRIX Placebo
SAEs† 7% 8% 26% 27%
Deaths§ 0.1% 0.5% 6% 6%
pIMDs (new onset or exacerbation)||     1.3% 1.0%

Additional Safety Information: Unsolicited Adverse Events, Serious Adverse Events, Deaths, and Potential Immune-Mediated Diseases Across 6 Trials of Immunocompromised Adults (TVC*)

Within 30 days following each vaccination
  SHINGRIX Placebo
Unsolicited AEs (serious and nonserious)† 46% 44%
From first administered dose up to 30 days post-last vaccination
  SHINGRIX Placebo
SAEs‡ 7% 8%
Deaths§ 0.1% 0.5%
From first administered dose up to 1 year post-last vaccination
  SHINGRIX Placebo
SAEs‡ 26% 27%
Deaths§ 6% 6%
pIMDs (new onset or exacerbation)|| 1.3% 1.0%
  • *

    Total vaccinated cohort included all patients who received at least one dose of SHINGRIX or placebo.

  • †

    Adverse events of arthralgia, infective pneumonia, and influenza-like illnesses occurred in ≥1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo (1.5% vs 1.0%, 1.5% vs 0.9%, and 1.3% vs 0.6%, respectively).

  • ‡

    Serious adverse events of infective pneumonia were reported in 21 (1.3%) recipients of SHINGRIX and 11 (0.7%) recipients of placebo up to 30 days post-last vaccination. A causal relationship to vaccination cannot be determined.

  • §

    Causes of death among subjects were consistent with those expected in the populations evaluated.

  • ‖

    There were no notable imbalances in specific pIMDs between treatment groups.

  •  
  •  

     AEs=adverse events; pIMDs=potential immune-mediated diseases; SAEs=serious adverse events.

Additional Safety Information: Other Medically Relevant Events (TVC*)

  From first vaccination to study end
Study Relapse/progression, SHINGRIX n/N, %
 Relapse/progression, placebo n/N, %
auHSCT (Zoster 001)†
 17/59 (29%)
 8/30 (27%)
auHSCT (Zoster 002)‡ 315/992 (34%) 331/924 (36%)
Hematologic malignancies 45/283 (16%) 58/279 (21%)
  Confirmed allograft rejection, SHINGRIX n/N (%) Confirmed allograft rejection, placebo n/N (%)
Renal transplant§ 4/132 (3%) 7/132 (5%)
  At least 1 event of worsening HIV, SHINGRIX n/N (%) At least 1 event of worsening HIV, placebo n/N (%)
HIV 9/74 (12%) 5/49 (10%)
  • *

    Total vaccinated cohort included all patients who received at least one dose of SHINGRIX or placebo.

  • †

    NCT00920218.

  • ‡

    NCT01610414.

  • §

    Creatinine as a measure of graft function and changes in alloimmunity post vaccination were not systematically evalusted.

  •  

  •  

    auHSCT=autologous hematopoietic stem cell transplant; HIV=human immunodeficiency virus; N=number of subjects in each group; n=number of subjects experiencing event; TVC=total vaccinated cohort.

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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.

    Questions About SHINGRIX?

    Call: 1-800-772-9292

    Available Monday - Friday

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