Efficacy Data

Only SHINGRIX delivered >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)

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

Cases and Incidence of PHN‡

Cases of PHN in the Pivotal Clinical Trials§
Age SHINGRIX Placebo
50-692,* 0/5631 10/5689
≥701,2,† 4/8250 36/8346
Efficacy of SHINGRIX on Overall Incidence of PHN
  Age Vaccine Efficacy % (95% CI)
  ≥502,† 91.2% (75.9, 97.7)
  ≥701,2,†
 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. The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed HZ could not be demonstrated.1

*Data from ZOE-50 phase 3 trial.1,3

†Pooled data from ZOE-50 and ZOE-70 phase 3 trials.1,2

§Number of subjects having PHN/number of subjects included in each group. PHN defined as HZ-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


CI=confidence interval; PHN=postherpetic neuralgia; HZ=herpes zoster

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. Subjects were followed for the development of herpes zoster (HZ) and postherpetic neuralgia (PHN) for a median of 3.1 years (range: 0 to 3.7 years).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. Subjects were followed for the development of HZ and PHN for a median of 3.9 years (range: 0 to 4.5 years).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 prespecified pooled analysis. A total of 8250 and 8346 subjects ≥70 years of age who received SHINGRIX and placebo, respectively, were included in the mTVC. Subjects were followed for the development of HZ and PHN for a median of 4.0 years (range: 0 to 4.5 years).1,4

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

You may also be interested in:

Safety Profile

Learn about the results of 2 phase 3 clinical trials in which adverse reactions to SHINGRIX were studied.

Shingles & Aging

Learn how age-related decline in immunity is a dominant driver of shingles and can lead to a sharp increase in both the incidence and complications of shingles.5-7

CDC Recommendations

See what CDC says about SHINGRIX.

 

CDC=Centers for Disease Control and Prevention.