• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Shingrix (Zoster Vaccine Recombinant, Adjuvanted)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Shingrix (Zoster Vaccine Recombinant, Adjuvanted)

  • Profile

Profile

Contact Information

Contact: GlaxoSmithKline
Website: http://www.shingrix.com/index.html

Currently Enrolling Trials

    Show More

    General Information

    Shingrix is a recombinant, adjuvanted vaccine against the virus that causes shingles.

    Shingrix is specifically indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

    Side Effects

    Adverse effects associated with the use of Shingrix may include, but are not limited to, the following:

    • pain
    • redness
    • swelling
    • myalgia
    • fatigue
    • headache
    • shivering
    • fever
    • gastrointestinal symptoms

    Dosing/Administration

    Shingrix is supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E (gE) antigen component, which must be reconstituted for intramuscular injection. After reconstitution, administer Shingrix immediately. The recommended dose schedule is two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at month 0 followed by a second dose administered any time between two and six months later. 

    Clinical Trial Results

    The FDA approval of Shingrix was based on a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. The primary efficacy analysis population (referred to as the modified Total Vaccinated Cohort [mTVC]) included 14,759 subjects aged 50 years and older who received 2 doses (0 and 2 months) of either Shingrix (n = 7,344) or placebo (n = 7,415) and did not develop a confirmed case of HZ within one month after the second dose. Compared with placebo, Shingrix significantly reduced the risk of developing HZ by 97.2 percent (95 percent CI: 93.7, 99.0) in subjects 50 years and older.

     

    Approval Date: 2017-10-01
    Company Name: GlaxoSmithKline
    Back to Listings

    Upcoming Events

    • 17May

      Three Data Trends to Consider Now When Developing Your Decentralized Clinical Trial Strategy

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing