Vaccine Information: Shingrix (Page 4 of 4)
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 |
| 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
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- Administer immediately or store refrigerated between 2° and 8°C (36° and 46°F) for up to 6 hours prior to use.
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- Discard reconstituted vaccine if not used within 6 hours.
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- Do not freeze. Discard if the vaccine has been frozen.
17 PATIENT COUNSELING INFORMATION
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- 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.
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- Inform patients about the potential for adverse reactions that have been temporally associated with administration of SHINGRIX.
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- 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
gE Recombinant Varicella Zoster Virus (VZV) glycoprotein E
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| Labeler — A-S Medication Solutions (830016429) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| A-S Medication Solutions | 830016429 | RELABEL (50090-3372) | |
Revised: 03/2021 A-S Medication Solutions
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