Last updated: 11/07/2018 11:20:06

Study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ seasonal influenza vaccine GSK2321138A in adults aged 50 years and older

GSK study ID
117036
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ seasonal influenza vaccine GSK2321138A in adults aged 50 years and older
Trial description: The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals’ HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with vaccine response to anti-gE antibodies

Timeframe: At one month post-dose 2 (Month 3)

Vaccine response for anti-gE humoral immunogenicity

Timeframe: At one month post-dose 2 (Month 3)

Adjusted geometric mean ELISA concentrations of anti-gE antibodies

Timeframe: At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)

FLU Haemagglutination inhibition (HI) antibody titers

Timeframe: At Day 21 post vaccination

Secondary outcomes:

Number of subjects with FLU HI antibody titers ≥1:10

Timeframe: At Day 0 (PRE) and 21 post vaccination

Number of seroprotected subjects with HI antibody titers ≥ 1:40

Timeframe: At Day 0 (PRE) and at Day 21 post vaccination

FLU Haemagglutination inhibition (HI) antibody titers

Timeframe: At Day 0 (PRE) and Day 21 post vaccination

Number of seroconverted subjects in terms of HI antibodies

Timeframe: At Day 21 post vaccination

Geometric mean ratio for Flu HI antibodies post-vaccination titer

Timeframe: At Day 21 post vaccination

Number of subjects with solicited local symptoms

Timeframe: Within 7 days (Days 0-6) after each vaccine dose

Number of subjects with solicited local symptoms

Timeframe: Within 7 days (Days 0-6) across doses

Number of subjects with solicited general symptoms

Timeframe: Within 7 days (Days 0-6) after each vaccine dose

Number of subjects with solicited general symptoms

Timeframe: Within 7 days (Days 0-6) after each vaccine dose

Number of subjects with solicited general symptoms

Timeframe: Within 7 days (Days 0-6) across doses

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During 30 days (Days 0-29) after vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: From first vaccination up to Month 18 (study end)

Number of subjects with potential immune-mediated diseases (pIMDs)

Timeframe: From first vaccination up to Month 18 (study end)

Interventions:
Biological/vaccine: Herpes Zoster vaccine GSK 1437173A
Biological/vaccine: GSK Biologicals’ quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A
Enrollment:
829
Observational study model:
Not applicable
Primary completion date:
2014-02-06
Time perspective:
Not applicable
Clinical publications:
Schwarz TF et al. (2017) Immunogenicity and safety of an adjuvanted Herpes Zoster Subunit Vaccine coadministered with seasonal influenza vaccine in adults aged 50 years or older. J Infect Dis. 216(11):1352-1361.
Medical condition
Herpes Zoster
Product
GSK1437173A, GSK2321138A
Collaborators
Not applicable
Study date(s)
October 2013 to March 2015
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
  • A male or female aged 50 years or older, at the time of the first vaccination with the study vaccine(s).
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23554
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13347
Status
Study Complete
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10717
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Status
Study Complete
Location
GSK Investigational Site
Freital, Sachsen, Germany, 01705
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Freiberg, Sachsen, Germany, 09599
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13125
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85018
Status
Study Complete
Location
GSK Investigational Site
Dippoldiswalde, Sachsen, Germany, 01744
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45355
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10787
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10117
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Floersheim, Hessen, Germany, 65439
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10629
Status
Study Complete
Location
GSK Investigational Site
Brampton, Ontario, Canada, L6T 0G1
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2014-02-06
Actual study completion date
2015-20-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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