Last updated: 07/17/2024 16:53:41

Study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) when co-administered with GSK Biologicals’ diphtheria, tetanus and pertussis vaccine (Boostrix®) in adults aged 50 years and older

GSK study ID
116887
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 Boostrix® 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 Boostrix® 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 a vaccine response for anti-glycoprotein E (anti-gE) in GSK1437173A Group

Timeframe: At 1 month post-Dose 2 (Month 3)

Antibody concentrations against glycoprotein E (anti-gE)

Timeframe: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)

Antibody concentrations against pertussis toxoid (anti-PT), filamentous hemagglutinin (anti-FHA) and pertactin (anti-PRN) antigens

Timeframe: At 1 month post-Dose 1 (Month 1)

Antibody concentrations against diphteria (anti-D) and tetanus (anti-T) antigens

Timeframe: At 1 month post-Dose 1 (Month 1)

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms, by dose

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any and Grade 3 solicited local symptoms, by study vaccine

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any, Grade 3 and related solicited general symptoms, by dose

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of days with solicited symptoms

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any and related potential Immune Mediated Diseases (pIMDs)

Timeframe: From first vaccination up to study end (Day 0 to Month 14)

Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)

Timeframe: Within the 30-day (Days 0-29) post-vaccination period

Number of subjects with any serious adverse events (SAEs)

Timeframe: From first vaccination up to study end (Day 0 to Month 14)

Interventions:
Biological/vaccine: Herpes Zoster vaccine GSK 1437173A
Biological/vaccine: Boostrix
Enrollment:
903
Observational study model:
Not applicable
Primary completion date:
2015-16-06
Time perspective:
Not applicable
Clinical publications:
Strezova A et al. (2019) The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial. Vaccine. 37(39):5877-5885.
Medical condition
Herpes Zoster
Product
GSK1437173A, SB776423
Collaborators
Not applicable
Study date(s)
February 2014 to April 2016
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.
  • 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
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29650
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Lewiston, Maine, United States, 04240
Status
Study Complete
Location
GSK Investigational Site
Boise, Idaho, United States, 83712
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28114
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Tucscon, Arizona, United States, 85704
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85712
Status
Study Complete
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Study Complete
Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
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
2015-16-06
Actual study completion date
2016-21-04

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

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website