- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075515
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
651
Phase
- 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
-
-
-
Gent, Belgium, 9000
- GSK Investigational Site
-
Wilrijk, Belgium, 2610
- GSK Investigational Site
-
-
-
-
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
-
-
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
2 doses administered intramuscularly in deltoid region of non-dominant arm.
Other Names:
|
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.
|
2 doses administered intramuscularly in deltoid region of non-dominant arm.
Other Names:
|
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.
|
2 doses administered intramuscularly in deltoid region of non-dominant arm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
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.
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)
August 13, 2014
Primary Completion (Actual)
April 29, 2015
Study Completion (Actual)
April 25, 2016
Study Registration Dates
First Submitted
February 27, 2014
First Submitted That Met QC Criteria
February 27, 2014
First Posted (Estimate)
March 3, 2014
Study Record Updates
Last Update Posted (Actual)
May 14, 2021
Last Update Submitted That Met QC Criteria
April 19, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Herpes Zoster
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineCanada, Spain, Korea, Republic of, United Kingdom, France, Czechia
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineUnited States, Estonia, Canada
-
Ohio State UniversityCompletedHerpes Zoster DiseaseUnited States
-
Merck Sharp & Dohme LLCCompletedHerpes Zoster | Herpes Zoster-related Complications
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineUnited States, Australia, Spain, Finland, Germany, Japan, Taiwan, Canada, Sweden, Korea, Republic of, Czechia, Hong Kong, Mexico, Italy, Brazil, Estonia, France, United Kingdom
-
Tanta UniversityNot yet recruitingAcute Herpes Zoster Pain Managment
-
Northwestern UniversityBausch & Lomb IncorporatedTerminatedHerpes Zoster KeratitisUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Centrexion TherapeuticsTerminatedAcute-onset Herpes Zoster PainAustralia
-
The University of Texas Medical Branch, GalvestonShriners Hospitals for ChildrenCompletedBurns | Chickenpox | Cytomegalovirus | Herpes Simplex Virus | Varicella-zoster Virus | Human Herpes Virus
Clinical Trials on Herpes Zoster vaccine (GSK 1437173A)
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedHerpes ZosterFrance, Spain, Taiwan, Belgium, Singapore, United States, Hong Kong, Russian Federation, Finland, Korea, Republic of, Czechia, Australia, Canada, Sweden, Poland, United Kingdom, Panama, Italy, Turkey, Pakistan, New Zealand
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineCanada, Spain, Korea, Republic of, United Kingdom, France, Czechia
-
GlaxoSmithKlineCompletedHerpes ZosterUnited States
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineUnited States, Estonia, Canada
-
GlaxoSmithKlineCompletedHerpes ZosterGermany, Czechia, Sweden, Netherlands