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.
14.4 Immunological eva luation to Support Dosing Schedule
A measure of the immune response that confers protection against HZ is unknown. Anti-gE antibody levels were measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA) and were used to support the dosing schedule.
In an open-label clinical study, 238 subjects 50 years and older received SHINGRIX on either a 0- and 2-month or 0- and 6-month sche