PROVEN SHINGLES PROTECTION

SHINGRIX delivered greater than 90 percent efficacy against shingles graphic

Data from ZOE-50 and pooled analysis from ZOE-50/-70.

Efficacy against shingles by age in adults ≥50 years old1

Age

Efficacy

Shingles cases (n) in SHINGRIX group (N)

Shingles cases (n) in placebo group (N)

50-59 years old*

96.6%

(95% CI: 89.6, 99.3)

3 (3492)

87 (3525)

60-69 years old*

97.4%

(95% CI: 90.1, 99.7)

2 (2141)

75 (2166)

70-79 years old†

91.3%

(95% CI: 86.0, 94.9)

19 (6468)

216 (6554)

Age ≥80†

91.4%

(95% CI: 80.2, 96.9)

6 (1782)

68 (1792)
  • *

    Data from the ZOE-50 phase 3 trial.1

  • †

    Pooled data from ZOE-50/-70 phase 3 trials.1

CI= confidence interval

n=number of subjects having at least 1 confirmed herpes zoster episode; N=number of subjects in each group.

Cases and incidence of postherpetic neuralgia (PHN)

Cases and incidences of postherpetic neuralgia in pivotal clinical trials

The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ. The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed herpes zoster could not be demonstrated.1

  • ‡

    Number of subjects having PHN/number of subjects included in each group. PHN defined as herpes zoster-associated pain rated as 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

  • §

    Data from ZOE-50 phase 3 trial.2

  • ||

    Pooled data from ZOE-50/-70 phase 3 trials.1

Results from a long-term, follow-up (LTFU) study:

Open-label, phase 3b, multicenter extension study of the ZOE-50/-70 clinical trials (descriptive analyses)5


Among the 13,881 patients from the mTVC who received SHINGRIX in the ZOE-50/-70 trials, 7273 participants were included in the mTVC of the LTFU extension study6,*


Historical controls were used as comparators during the LTFU study.6

SHINGRIX long-term data results graphic

Patient follow-up varied, from up to ~4 years in ZOE-50/-70 (for patients not enrolled in the LTFU extension study) up to ~11 years for subjects enrolled in LTFU study.1,7

  • *

    15 participants with confirmed HZ cases from ZOE-50/-70 were excluded in the primary analysis of the LTFU.6

  • †

    Age at time of vaccination.

  • ‡

    Historical control group: based on placebo groups in the parent studies with the number of participants (N) and follow-up time assumed to be the same as in the vaccinated group.7

  • §

    Participants from the SHINGRIX group in the ZOE-50/-70 were used for Y 1-4, and participants from LTFU study were used from Y 6 onward.7

  • ‖

    Participants from the placebo groups in ZOE-50/-70 were used for Y 1-4, and participants in the placebo groups in ZOE-50/-70 were used to form the historical control data for Y 6 onward in the LTFU study. The number of participants and follow-up time for the historical control group were assumed to be the same as the SHINGRIX group over the LTFU study.7

Note: VE estimates were adjusted for region.

CI=confidence interval; HZ=herpes zoster; LTFU=long-term follow-up; M=month; mTVC=modified Total Vaccinated Cohort; n = number of individuals having ≥1 confirmed HZ episode. For the historical control group, n represent the number of projected cases of HZ based on incident rate data from the placebo groups in ZOE-50/-70; N = number of individuals in each group; VE=vaccine efficacy; Y=year.

Key secondary endpoint: Safety

During the LTFU extension study, no deaths or other serious adverse events were considered related to vaccination by the investigators.6

Long-term data by year in adults ≥50 years7,*

Descriptive analyses
SHINGRIX long-term data by year in adults 50 plus

    

  • *

    Age at time of vaccination.

  • †

    Participants from the SHINGRIX group in the ZOE-50/-70 were used for Y 1-4, and participants from LTFU study were used from Y 6 onward.7

  • ‡

    Participants from the placebo groups in ZOE-50/-70 were used for Y 1-4, and participants in the placebo groups in ZOE-50/-70 were used to form the historical control data for Y 6 onward in the LTFU study. The number of participants and follow-up time for the historical control group were assumed to be the same as the SHINGRIX group over the LTFU study.7 (Y 6 onward)

  • CI=confidence interval; HZ=herpes zoster; LTFU=long-term follow-up; n=number of individuals with a confirmed HZ episode. For the historical control group, n represents the modeled number of placebo participants with an HZ episode based on historical incidence rate data from ZOE-50/-70; N=number of individuals in each group; Y=year.

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 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. Cunningham AL, Lal H, Kovac M, et al, for the ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-1032.
  3. 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.
  4. Data on file. Study 113077 (NCT01165229). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=113077
  5. A long-term follow-up study (ZOE-LTFU) of two studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals’ herpes zoster subunit (HZ/su) vaccine and assessment of 1 or 2 additional doses in two subgroups of older adults. Clinicaltrials.gov identifier NCT02723773. Available at: clinicaltrials.gov/study/NCT02723773
  6. Strezova A, Diez-Domingo J, Tinoco JC, et al. Adjuvanted recombinant zoster vaccine (RZV) is the first vaccine to provide durable protection against herpes zoster (HZ) in all age ranges ≥50 years: final analysis of efficacy and safety after 11 years (Y) of follow-up. Poster presented at: European Congress of Clinical Microbiology and Infectious Diseases Annual Meeting; April 23-27, 2024; Barcelona, Spain.
  7. Strezova A, Diez-Domingo J, Tinoco JC, et al. Adjuvanted recombinant zoster vaccine (RZV) is the first vaccine to provide durable protection against herpes zoster (HZ) in all age ranges ≥50 years: final analysis of efficacy and safety after 11 years (Y) of follow-up. Abstract presented at: European Congress of Clinical Microbiology and Infectious Diseases Annual Meeting; April 23-27, 2024; Barcelona, Spain.
  8. Data on file, GSK.

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