Efficacy Data

Recommend SHINGRIX to patients ≥50 years old

Only SHINGRIX delivered >90% efficacy against shingles regardless of age in those 50 years and older.1,*
 Age Efficacy
(95% CI)
 Shingles cases
(n) in SHINGRIX
group (N)
 Shingles cases
(n) in placebo
group (N)
50-59† 96.6%
(89.6, 99.3)		 3
(3492)

87
(3525)
60-69† 97.4%
(90.1, 99.7)		 2
(2141)		 75
(2166)
70-79‡
 91.3%
(86.0, 94.9)		 19
(6468)		 216
(6554)
≥80‡ 91.4%
(80.2, 96.9)		 6
(1782)		 68
(1792)

*Data from the phase 3 ZOE-50 (≥50 years of age) trial and pooled data in individuals ≥70 years of age from the phase 3 ZOE-50 and ZOE-70 trials. See study designs 1 and 2 below for more details.1

†Data from the ZOE-50 phase 3 trial.

‡Pooled data from ZOE-50 and ZOE-70 phase 3 trials.

 

Cl=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 PHN*

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

†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

‡Data from ZOE-50 phase 3 trial.

§Pooled data from ZOE-50 and ZOE-70 phase 3 trials.

 

Cl=confidence interval; HZ=herpes zoster; PHN=postherpetic neuralgia.

  • Study Designs 1 & 2

    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 mTVC analysis. Subjects were followed for the development of HZ and PHN for a median of 3.1 years (range: 0 to 3.7 years).1,6

    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).1,7

    The studies excluded subjects who were immunocompromised, had a 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

    HZ=herpes zoster; mTVC=modified Total Vaccinated Cohort; N=number of indiduals included in each group; PHN=postherpetic neuralgia1

Long-Term Data (Interim Analysis Results)

 

Long-Term Follow-Up Study (ZOSTER-049) in Adults ≥50 Years and Older
Descriptive Analysis3,4

At the time of the ZOSTER-049 LTFU interim analysis not all participants reached a full 10 years of follow-up. Data subject to change as the remaining patients complete year 10.

 

The DLP for this interim analysis was on the date when participants had completed at least 4 additional years of follow-up, and data accrual was complete through year 9. Available results for year 10 are also included, although still incomplete at this DLP.

 

Among the 13,881 subjects from the mTVC who received SHINGRIX in the ZOE-50/70 trials, 7277 subjects were followed in the extension study, ZOSTER-049.

 

No data are available for the gap period between ZOE-50/70 and ZOSTER-049 extension study.

 

CI=confidence interval; DLP=data lock point; LTFU=long-term follow-up; n=number of individuals with a confirmed herpes zoster (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. The historical control group was modeled by matching the number of subjects in the SHINGRIX group from the ZOE-50/70 studies and adjusted for age and region at randomization.3,5

Efficacy Data Over Time (Descriptive Analysis, Secondary Endpoint)3

 

At the time of the LTFU interim analysis not all participants reached a full 10 years of follow-up. Data subject to change as the remaining patients complete year 10.

 

*The historical control group was modeled by matching the number of subjects in the SHINGRIX group from the ZOE-50/70 studies and adjusted for age and region at randomization.

 

†The data lock point (DLP) for this interim analysis was on the date when participants had completed at least 4 additional years of follow-up, and data accrual was complete through Year 9. Available results for Year 10 are also included, although still incomplete at this DLP.

 

No data are available for the gap period between ZOE-50/70 and the ZOSTER-049 extension study.

 

CI=95% Confidence interval; DLP=data lock point; HZ=herpes zoster; LTFU=long-term follow-up; n=number of individuals with a confirmed herpes zoster (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.

  • Long-Term Follow-Up Study Design

    Long-Term Follow-Up (ZOSTER-049) Study Design3,5:

     

    Data from an ongoing phase 3B open-label extension study of ZOE-50 (adults ≥50 years) and ZOE-70 (adults ≥70 years). Of the 14,648 participants who received at least 1 dose of SHINGRIX, 7413 were enrolled for the long-term efficacy assessment, of which 7277 had previously received both doses of SHINGRIX and were included in the mTVC for the vaccine efficacy assessment.

     

    The primary objective of this interim analysis was to assess the efficacy of SHINGRIX in the prevention of HZ over the total duration of the ZOSTER-049 LTFU study, from a mean of 5.6 (+/- 0.3) years to 9.6 (+/- 0.3) years post-vaccination.

     

    The results of this interim analysis are based on data collected after at least 4 of the 6 additional years of follow-up from the ZOSTER-049 LTFU study. This data is subject to change upon final analysis.

     

    The pooled overall vaccine efficacy analysis (ZOE-50/70 and the ZOSTER-049 LTFU study) is calculated based on pooled subjects from the vaccinated groups from ZOE-50/70 and the ZOSTER-049 LTFU study versus historical estimates for the placebo control arm. The study was initiated on April 16, 2016, and the data lock point for this second interim analysis was on August 19, 2021, when participants had completed at least 4 additional years of follow-up. All analyses are descriptive.

     

    Efficacy was evaluated in the mTVC, restricted to participants who received both doses of SHINGRIX in the ZOE-50/70 studies and did not develop a confirmed HZ episode before 1 month after dose 2.

     

    No deaths or other SAEs were considered causally related to vaccination by the investigator during the ZOSTER-049 LTFU study up to this interim analysis.

     

     

    Some Limitations of the ZOSTER-049 LTFU Study Are3,5:

    • Almost half of the former ZOE-50/70 participants did not enroll in this LTFU study
    • At the data lock point for the present interim analysis, not all participants reached a full 10 years of follow-up
    • HZ cases that occurred during the 1-year gap between the ZOE-50/70 and this LTFU study were only recorded at enrollment, without being confirmed per the same protocol. Therefore, vaccine efficacy for Year 5 could not be estimated
    • This LTFU study did not have a concomitant placebo group, as placebo recipients from ZOE-50/70 had received SHINGRIX in a subsequent study. Hence, HZ incidence from the placebo group estimates of the ZOE-50/70 studies (adjusted for age and region at randomization in ZOE-50/70) were used to calculate vaccine efficacy estimates in the present LTFU study

    HZ=herpes zoster; mTVC=modified Total Vaccinated Cohort; N=number of individuals included in each group; PHN=postherpetic neuralgia.

You may also be interested in:

Reconstitution & Administration

See how you and your staff can reconstitue SHINGRIX in 4 steps.

Storage & Dosing

 

Learn how to store SHINGRIX and about the importance of proper dosing.

Patient Counseling

 

Talk to your patients about what to expect, including common adverse reactions.