- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01751165
Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older
Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Tartu, Estonia, 50106
- GSK Investigational Site
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California
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Spring Valley, California, United States, 91978
- GSK Investigational Site
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Kansas
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Wichita, Kansas, United States, 67207
- GSK Investigational Site
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Pennsylvania
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Uniontown, Pennsylvania, United States, 15401
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 two 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. For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, 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 and ending 30 days after either dose of study vaccine.
- Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine.
- Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
- Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study).
- Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
- History of HZ.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g. medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) for oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) for rectal route. The preferred route for recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- Pregnant or lactating female.
- Female planning to become pregnant during the entire treatment period and for two months after completion of the vaccination series, or planning to discontinue contraceptive precautions (if of childbearing potential).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: HZ/su-0,2 Group
Subjects will receive HZ/su vaccine on a 0,2-month schedule.
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2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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Experimental: HZ/su-0,6 Group
Subjects will receive HZ/su vaccine on a 0,6-month schedule.
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2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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Experimental: HZ/su-0,12 Group
Subjects will receive HZ/su vaccine on a 0,12-month schedule.
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2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame: At one month (M1) after Dose 2
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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. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules. |
At one month (M1) after Dose 2
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Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Time Frame: At one month (M1) after Dose 2
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At one month (M1) after Dose 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Time Frame: Prior (PRE) to vaccination and twelve (M12) post Dose 2
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Prior (PRE) to vaccination and twelve (M12) post Dose 2
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Number of Subjects With Solicited Local Symptoms.
Time Frame: During the 7 day period (Days 0-6) following each dose (D)
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Solicited local symptoms assessed include pain, redness and swelling.
"Grade 3 pain" was defined as crying when limb was moved/spontaneously painful.
"Grade 3 swelling/redness" was defined as swelling/redness larger than (>) 100 millimeters (mm).
"Any" is defined as incidence of the specified symptom regardless of intensity.
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During the 7 day period (Days 0-6) following each dose (D)
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Number of Subjects With Solicited General Symptoms.
Time Frame: During the 7 day period (Days 0-6) following each dose (D)
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Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]).
"Any" = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination.
"Related" = occurrence of the specified symptom assessed by the investigators as causally related to vaccination.
"Grade 3 Fatigue" = fatigue that prevented normal activity.
"Grade 3 Gastrointestinal" = gastrointestinal that prevented normal every day activities.
"Grade 3 Headache" = headache that prevented normal activity.
"Grade 3 Myalgia" = myalgia that prevented normal activity.
"Grade 3 Shivering" = shivering that prevented normal activity.
"Grade 3 Temperature" = temperature higher than (>) 39.0°C.
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During the 7 day period (Days 0-6) following each dose (D)
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Number of Subjects With Unsolicited Adverse Events (AEs).
Time Frame: During the 30 Days (Day 0-29) following vaccination
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An adverse event (AE) is 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.
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During the 30 Days (Day 0-29) following vaccination
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Number of Subjects With Serious Adverse Events (SAEs).
Time Frame: From first vaccination up to one month (30 Days) post last vaccination
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SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
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From first vaccination up to one month (30 Days) post last vaccination
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Number of Subjects With SAE(s).
Time Frame: Starting from 30 Days post last vaccine administration up to study end at Month 24
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SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
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Starting from 30 Days post last vaccine administration up to study end at Month 24
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Number of Days With Solicited Local Symptoms.
Time Frame: During the 7 Days (Day 0-6) following vaccination
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Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
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During the 7 Days (Day 0-6) following vaccination
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Number of Days With Solicited General Symptoms.
Time Frame: During the 7 Days (Day 0-6) following vaccination
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Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
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During the 7 Days (Day 0-6) following vaccination
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Number of Subjects With Potential Immune-mediated Diseases (pIMDs).
Time Frame: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
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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.
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From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
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Number of Subjects With pIMDs.
Time Frame: From one month (30 Days) following the last vaccine administration up to study end at Month 24
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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.
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From one month (30 Days) following the last vaccine administration up to study end at Month 24
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 116697
- 2012-004456-11 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- 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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