ONLY SHINGRIX DELIVERS >90% EFFICACY AGAINST SHINGLES REGARDLESS OF AGE IN THOSE 50 YEARS AND OLDER1

 
 
AGE 50-59* 60-69* 70-79 ≥80
EFFICACY (95% CI) 96.6%
(89.6, 99.3)
97.4%
(90.1, 99.7)
91.3%
(86.0, 94.9)
91.4%
(80.2, 96.9)
SHINGLES CASES (n)
IN SHINGRIX GROUP (N)
3
(3492)
2
(2141)
19
(6468)
6
(1782)
SHINGLES CASES (n)
IN PLACEBO GROUP (N)
87
(3525)
75
(2166)
216
(6554)
68
(1792)

Images do not depict actual patients.

* Data from ZOE-50 phase 3 trial.1
Pooled data from ZOE-50 and ZOE-70 phase 3 trials.1
The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed HZ could not be demonstrated.1

  CI=confidence interval.
  HZ=herpes zoster.
  n=number of subjects having at least 1 confirmed HZ episode.
  N=number of subjects in each group.
  PHN=postherpetic neuralgia.

VACCINE EFFICACY AGAINST OVERALL PHN1,2,§

Cases of PHN in the clinical trials

  SHINGRIX Placebo
AGES 50-69* 0/5631 10/5689
AGES ≥70 4/8250 36/8346
SHINGRIX efficacy against PHN 95% CI
AGES ≥50 91.2% (75.9, 97.7)
AGES ≥70 88.8% (68.7, 97.1)
§ The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.
 
 

Study 1 Design: Data from ZOE-50—a placebo-controlled, observer-blind phase 3 trial conducted in 18 countries in which subjects ≥50 years old were randomized to receive 2 doses (0 and 2 months) of either SHINGRIX (N=7698) or placebo (N=7713). A total of 7344 and 7415 subjects who received SHINGRIX and placebo, respectively, were included in the modified Total Vaccinated Cohort (mTVC) analysis.1,3

Study 2 Design: Data from ZOE-70—a placebo-controlled, observer-blind phase 3 trial conducted in 18 countries in which subjects ≥70 years old were randomized to receive 2 doses (0 and 2 months) of either SHINGRIX (N=6950) or placebo (N=6950). A total of 6541 and 6622 subjects who received SHINGRIX and placebo, respectively, were included in the mTVC analysis.1,2

The primary efficacy analysis (mTVC) in Studies 1 and 2 included all subjects who did not develop a confirmed case of HZ within 1 month after the second dose.1

Pooled Analysis: Data from ZOE-50 and ZOE-70 were combined in a pre-specified pooled analysis. A total of 8250 and 8346 subjects ≥70 years of age who received SHINGRIX and placebo, respectively, were included.1

The studies excluded subjects who were immunocompromised, had a previous history of HZ, were previously vaccinated against varicella or HZ, and patients whose survival was not expected to be at least 4 years, or with conditions that might interfere with study evaluations.1


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

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.

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1004182R0 April 2018