Shingrix: Package Insert and Label Information (Page 3 of 3)

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.

14.4 Immunological Evaluation 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 schedule. Non-inferiority of the 0- and 6-month schedule compared with the 0- and 2-month schedule based on anti-gE ELISA GMCs 1 month after the second dose was demonstrated.

14.5 Concomitant Administration with Influenza Vaccine

In an open-label clinical study, subjects 50 years and older received 1 dose each of SHINGRIX and FLUARIX QUADRIVALENT (QIV) at Month 0 and 1 dose of SHINGRIX at Month 2 (n = 413), or 1 dose of QIV at Month 0 and 1 dose of SHINGRIX at Months 2 and 4 (n = 415). There was no evidence for interference in the immune response to any of the antigens contained in SHINGRIX or the coadministered vaccine.

16 HOW SUPPLIED/STORAGE AND HANDLING

SHINGRIX is supplied as 2 components: A single-dose vial of lyophilized gE antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles).

Table 6: Product Presentations for SHINGRIX

Presentation

Carton NDC Number

Components

Adjuvant Suspension Component (liquid)

Lyophilized gE Antigen Component (powder)

An outer carton of 1 dose

58160-819-12

Vial 1 of 2

NDC 58160-829-01

Vial 2 of 2

NDC 58160-828-01

An outer carton of 10 doses

58160-823-11

10 vials

NDC 58160-829-03

10 vials

NDC 58160-828-03

16.1 Storage before Reconstitution

Adjuvant suspension component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the adjuvant suspension has been frozen.

Lyophilized gE antigen component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the antigen component has been frozen.

16.2 Storage after Reconstitution

Administer immediately or store refrigerated between 2° and 8°C (36° and 46°F) for up to 6 hours prior to use.
Discard reconstituted vaccine if not used within 6 hours.
Do not freeze. Discard if the vaccine has been frozen.

17 PATIENT COUNSELING INFORMATION

Inform patients of the potential benefits and risks of immunization with SHINGRIX and of the importance of completing the 2-dose immunization series according to the schedule.
Inform patients about the potential for adverse reactions that have been temporally associated with administration of SHINGRIX.
Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Trademarks are owned by or licensed to the GSK group of companies.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, U.S. License 1617, and

Distributed by GlaxoSmithKline

Research Triangle Park, NC 27709

©2019 GSK group of companies or its licensor.

SHX:4PI

PRINCIPAL DISPLAY PANEL

NDC 58160-819-12

SHINGRIX

Zoster Vaccine Recombinant, Adjuvanted

Rx only

NOTICE: One vial of lyophilized powder and one vial of liquid suspension MUST BE COMBINED BEFORE USE

For 50 Years of Age and Older

Contents (a single dose of SHINGRIX):

1 Vial containing Lyophilized gE Antigen Component

1 Vial containing Adjuvant Suspension Component

After reconstitution, a single dose of SHINGRIX is 0.5 mL

Antigen and Adjuvant Made in Belgium

©2019 GSK group of companies or its licensor.

498197 Rev. 6/19
Shingrix 1 count carton
(click image for full-size original)

One Count Adjuvant Vial Label

NDC 58160-829-01

490627 Rev. 10/17
Shingrix 1 count Adjuvant vial label
(click image for full-size original)

One Count Antigen Vial Label

NDC 58160-828-01

490628 Rev. 10/17
Shingirx 1 count Antigen vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58160-823-11

SHINGRIX

Zoster Vaccine Recombinant, Adjuvanted

Rx only

For 50 Years of Age and Older

Contents (10 doses of SHINGRIX):

10 Vials containing Lyophilized gE Antigen Component

10 Vials containing Adjuvant Suspension Component

After reconstitution, a single dose of SHINGRIX is 0.5 mL

Antigen and Adjuvant Made in Belgium

©2018 GSK group of companies or its licensor.

495520 Rev. 11/18
Shingrix 10 count carton.
(click image for full-size original)

10 Count Adjuvant Vial Label

NDC 58160-829-03

490658 Rev. 10/17
Shingrix 10 count adjuvant vial label
(click image for full-size original)

10 Count Antigen Vial Label

NDC 58160-828-03

490735 Rev. 10/17
Shingrix 10 count antigen vial label
(click image for full-size original)
SHINGRIX
zoster vaccine recombinant, adjuvanted kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-819
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-819-12 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 VIAL 1 mL
Part 2 2 VIAL 1 mL
Part 1 of 2
SHINGRIX
ge recombinant varicella zoster virus (vzv) glycoprotein e injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:58160-828
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN (RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN) RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
POLYSORBATE 80
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
DIBASIC POTASSIUM PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-828-01 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Part 2 of 2
AS01B
as01b suspension
Product Information
Item Code (Source) NDC:58160-829
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
MONOPHOSPHORYL LIPID A
QS-21
DIOLEOYLPHOSPHATIDYLCHOLINE, DL-
CHOLESTEROL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-829-01 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
SHINGRIX
zoster vaccine recombinant, adjuvanted kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-823
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-823-11 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 20 VIAL 10 mL
Part 2 20 VIAL 10 mL
Part 1 of 2
SHINGRIX
ge recombinant varicella zoster virus (vzv) glycoprotein e injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:58160-828
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN (RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN) RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
POLYSORBATE 80
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
DIBASIC POTASSIUM PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-828-03 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Part 2 of 2
AS01B
as01b suspension
Product Information
Item Code (Source) NDC:58160-829
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
MONOPHOSPHORYL LIPID A
QS-21
DIOLEOYLPHOSPHATIDYLCHOLINE, DL-
CHOLESTEROL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-829-03 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 10/2019 GlaxoSmithKline Biologicals SA

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