Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age

April 19, 2021 updated by: GlaxoSmithKline

Consistency, Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 50 Years of Age or Older

The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
651

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Wilrijk, Belgium, 2610
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • GSK Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85213
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • GSK Investigational Site
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • Written informed consent obtained from the subject.

  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine.
  • Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Previous vaccination against HZ or varicella.
  • Planned administration during the study of an HZ or varicella vaccine other than the study vaccine.
  • History of HZ.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

  • Acute disease and/or fever at the time of enrollment.

    • Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) on rectal route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating females.
  • Females planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 4.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
  • Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HZ/su Lot A
Subjects will receive Lot A of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.
Biological: Herpes Zoster vaccine (GSK 1437173A)
2 doses administered intramuscularly in deltoid region of non-dominant arm.
Other Names:
  • HZ/su vaccine
Experimental: HZ/su Lot B
Subjects will receive Lot B of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.
Biological: Herpes Zoster vaccine (GSK 1437173A)
2 doses administered intramuscularly in deltoid region of non-dominant arm.
Other Names:
  • HZ/su vaccine
Experimental: HZ/su Lot C
Subjects will receive Lot C of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.
Biological: Herpes Zoster vaccine (GSK 1437173A)
2 doses administered intramuscularly in deltoid region of non-dominant arm.
Other Names:
  • HZ/su vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
Time Frame: At Month 3
Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).
At Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anti-gE Humoral Immunogenicity
Time Frame: At Month 0 and Month 3
Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).
At Month 0 and Month 3
Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA
Time Frame: At Month 3
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
At Month 3
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time Frame: Within 7 days (Days 0-6) after each vaccine dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activities.
Within 7 days (Days 0-6) after each vaccine dose and across doses
Number of Days With Any Solicited Local Symptoms
Time Frame: During the 7 days (Days 0-6) after each vaccine dose
The number of days with any local symptoms reported during the solicited post-vaccination period.
During the 7 days (Days 0-6) after each vaccine dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time Frame: Within 7 days (Days 0-6) after each vaccine dose and across doses
Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature= temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Within 7 days (Days 0-6) after each vaccine dose and across doses
Number of Days With Any Solicited General Symptoms
Time Frame: During the 7 days (Days 0-6) after each vaccine dose
The number of days with any general symptoms reported during the solicited post-vaccination period.
During the 7 days (Days 0-6) after each vaccine dose
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Time Frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time Frame: During 30 days (Days 0-29) after each vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During 30 days (Days 0-29) after each vaccination
Number of Subjects With Any Serious Adverse Events (SAEs)
Time Frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 117177
  • 2013-000373-76 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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