Completed

Study Description:

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals’ HZ/su vaccine in subjects’ ≥ 50 years of age (YOA) who previously have had Herpes Zoster (HZ). The data collected will be compared with the data from subjects without HZ in other HZ/su trials.

GSK Study ID:

116796


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT01827839


Has Results Available Below
EudraCT Number:

2012-003643-30


Study Overview

Medical Conditions

Herpes Simplex Virus (HSV)

Product

GSK1437173A

Collaborators

N/A


Date

June 2013 to November 2014

Type

Interventional

Phase

3


Gender

All

Age

50 years - N/A

Accepts Healthy Volunteers

Yes


This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

Canada, British Columbia, Coquitlam V3K 3P4Completed
Canada, Québec, Pointe-Claire H9R 4S3Completed
Russia, Barnaul 656056Completed
Russia, Ekaterinburg 620137Completed

Study Design

  • Primary Purpose: Prevention
  • Allocation: Not Available
  • Study Design: Single Group Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Number of vaccine responders for anti-gE antibodies as determined by ELISA
    Timeframe: At Month 3

  • Number of subjects with any and Grade 3 solicited local symptoms
    Timeframe: Within 7 days (Day 0-6) after each vaccine dose and across doses

  • Number of days with solicited local symptoms
    Timeframe: Within 7 days (Day 0-6) after each vaccine dose

  • Number of subjects with any, Grade 3 and related solicited general symptoms
    Timeframe: Within 7 days (Day 0-6) after each vaccine dose and across doses

  • Number of days with solicited general symptoms
    Timeframe: Within 7 days (Day 0-6) after each vaccine dose

  • Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
    Timeframe: Within 30 days (Days 0-29) after each vaccination

  • Number of subjects with any Serious Adverse Events (SAEs)
    Timeframe: From first vaccination up to 30 days post last vaccination

  • Number of subjects with any potential immune-mediated diseases (pIMDs)
    Timeframe: From first vaccination up to 30 days post last vaccination

Secondary Outcomes:

  • Anti-gE antibody concentrations
    Timeframe: At Month 0 and at Month 3

  • Number of subjects with anti-gE antibody concentrations equal to or above the cut-off value
    Timeframe: At Month 0 and at Month 3

  • Number of subjects with SAEs
    Timeframe: Starting after 30 days post last vaccination until study end (i.e. Month 14)

  • Number of subjects with any potential immune-mediated diseases (pIMDs)
    Timeframe: Starting after 30 days post last vaccination until study end (i.e. Month 14)

Arms:
  • 1

Interventions:

  • Biological/Vaccine: Herpes Zoster vaccine (GSK1437173A)

Keyword:

  • Adults, Safety, Immunogenicity, Zoster
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 96

Clinical Publications:

  • Godeaux O et al. (2017) Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ?50 years of age with a prior history of herpes zoster: a phase III, non-randomized, open-label clinical trial. Hum Vaccin Immunother. 11(9):1-8.