Vaccine Information: Shingrix (Page 3 of 4)

14.2 Efficacy in Subjects 70 Years and Older

Study 2 was a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. Randomization was stratified (3:1) by age: 70 to 79 years and ≥80 years. With the exception of age, the study exclusion criteria were the same as for Study 1. Subjects were followed for the development of HZ and PHN for a median of 3.9 years (range: 0 to 4.5 years). Suspected HZ cases were followed prospectively for the development of PHN as for Study 1.

The primary efficacy analysis population (mTVC) included 13,163 subjects aged 70 years and older who received 2 doses (0 and 2 months) of either SHINGRIX (n = 6,541) or placebo (n = 6,622) and did not develop a confirmed case of HZ within 1 month after the second dose. In the mTVC population, 54.7% were female; 77.6% were white, 17.1% were Asian, 1.0% were black, and 4.2% were of other racial/ethnic groups. The mean age of subjects was 75.5 years.

Confirmed HZ cases were determined by either PCR (92.3%) or by a Clinical Evaluation Committee (7.7%).

Efficacy against Herpes Zoster

Vaccine efficacy results against HZ in subjects 70 years and older are shown in Table 3.

Table 3. Efficacy of SHINGRIX on Incidence of Herpes Zoster Compared with Placebo in Study 2a (mTVCb)

Age Group (Years)

SHINGRIX

Placebo

% Efficacy (95% CI)

N

n

Incidence Rate of HZ per 1,000 Person-Years

N

n

Incidence Rate of HZ per 1,000 Person-Years

Overall (≥70)c

6,541

23

0.9

6,622

223

9.2

89.8

(84.3, 93.7)

70 — 79

5,114

17

0.9

5,189

169

8.8

90.0

(83.5, 94.3)

≥80

1,427

6

1.2

1,433

54

11.0

89.1

(74.7, 96.2)

N = Number of subjects included in each group; n = Number of subjects having at least 1 confirmed HZ episode; HZ = Herpes zoster; CI = Confidence Interval.

a Study 2: NCT01165229.

b mTVC = Modified Total Vaccinated Cohort defined as subjects who received 2 doses (0 and 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of HZ within 1 month after the second dose.

c Primary study endpoint was based on confirmed HZ cases in subjects aged 70 years and older.

In a descriptive analysis, vaccine efficacy against HZ in subjects 70 years and older was 85.1% (95% CI: 64.5, 94.8) in the fourth year after vaccination.

Efficacy against PHN

Among all subjects aged 70 years or older in the mTVC, 4 cases of PHN were reported in the vaccine group, compared with 28 cases reported in the placebo group. Vaccine efficacy against PHN was 85.5% (95% CI: [58.5; 96.3]). The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.

Reduction of Use of Pain Medication

Among subjects with confirmed HZ, the use of HZ-associated pain medications was reported for 10 of 23 subjects (43.5%) who received SHINGRIX and for 160 of 223 subjects (71.7%) who received placebo.

14.3 Pooled Efficacy Analyses across Studies 1 and 2

The efficacy of SHINGRIX to prevent HZ and PHN in subjects 70 years and older was evaluated by combining the results from Studies 1 and 2 through a pre-specified pooled analysis in the mTVC. A total of 8,250 and 8,346 subjects who received SHINGRIX and placebo, respectively, were included in the pooled mTVC analysis.

Efficacy against Herpes Zoster

Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ by 91.3% (95% CI: 86.9, 94.5) in subjects 70 years and older (Table 4).

Table 4. Efficacy of SHINGRIX on Incidence of Herpes Zoster Compared with Placebo in Studies 1 and 2 (Pooled Dataa) (mTVCb)

Age Group (Years)

SHINGRIX

Placebo

% Efficacy (95% CI)

N

n

Incidence Rate of HZ per 1,000 Person-Years

N

n

Incidence Rate of HZ per 1,000 Person-Years

Overall (≥70)c

8,250

25

0.8

8,346

284

9.3

91.3

(86.9, 94.5)

70 — 79

6,468

19

0.8

6,554

216

8.9

91.3

(86.0, 94.9)

≥80

1,782

6

1.0

1,792

68

11.1

91.4

(80.2, 96.9)

N = Number of subjects included in each group; n = Number of subjects having at least 1 confirmed HZ episode; HZ = Herpes zoster; CI = Confidence Interval.

a Pooled data from Study 1: NCT01165177 (subjects ≥50 years) and Study 2: NCT01165229 (subjects ≥70 years).

b mTVC = Modified Total Vaccinated Cohort defined as subjects who received 2 doses (0 and 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of HZ within 1 month after the second dose.

c Primary endpoint of pooled analysis was based on confirmed HZ cases in subjects 70 years and older.

Efficacy against PHN

Table 5 compares the overall rates of PHN in the vaccine and placebo groups across both studies.

Table 5. Efficacy of SHINGRIX on Overall Incidence of Postherpetic Neuralgia Compared with Placebo in Studies 1 and 2 (Pooled Dataa) (mTVCb)

Age Group (Years)

SHINGRIX

Placebo

% Efficacy (95% CI)

N

n

Incidence Rate of PHNc per 1,000 Person-Years

N

n

Incidence Rate of PHN per 1,000 Person-Years

Overall (≥70)

8,250

4

0.1

8,346

36

1.2

88.8

(68.7, 97.1)

70 — 79

6,468

2

0.1

6,554

29

1.2

93.0

(72.5, 99.2)

≥80

1,782

2

0.3

1,792

7

1.1

71.2

(-51.5, 97.1)

N = Number of subjects included in each group; n = Number of subjects having at least 1 PHN; CI = Confidence Interval.

a Pooled data from Study 1: NCT01165177 (subjects ≥50 years) and Study 2: NCT01165229 (subjects ≥70 years).

b mTVC = Modified Total Vaccinated Cohort defined as subjects who received 2 doses (0 and 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of HZ within 1 month after the second dose.

c PHN = Postherpetic neuralgia 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.

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.

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