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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2014 |
Main ID: |
EUCTR2010-022248-19-SE |
Date of registration:
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21/12/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals’ candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older. - ZOSTER-024
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Scientific title:
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An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals’ candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older. - ZOSTER-024 |
Date of first enrolment:
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25/01/2011 |
Target sample size:
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167 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022248-19 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Germany
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Netherlands
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria: 1)Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. return for follow-up visits) 2)Previous participation in study ZOSTER-003 as a member of the 50µg gE/AS01B vaccine group; 3)Written informed consent obtained from the subject.
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1)Having participated in another study at any time after ZOSTER-003 study end in which the subject was exposed to an investigational or non-investigational product (pharmaceutical product or device) or; 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 (pharmaceutical product or device); 2)Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw; 3)Having received a vaccine containing 3-O-desacyl-4’-Monophosphoryl Lipid A (MPL) and/or Quillaja saponaria Molina, fraction 21 (QS21), any time after ZOSTER-003 study end; 4)Having received a vaccine against HZ any time after ZOSTER-003 study end; 5)Subject who did not receive a complete vaccination course of 2 doses of 50µg gE/AS01B in study ZOSTER-003;
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Evaluation of persistence of immune responses following immunisation of healthy elderly subjects (60-69 and =70 years) against Herpes Zoster (HZ) MedDRA version: 12.1
Level: LLT
Classification code 10019974
Term: Herpes zoster
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Intervention(s)
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Product Name: gE recombinant protein formulated in AS01B Adjuvant System Product Code: gE/AS01B Pharmaceutical Form: Powder and solvent for suspension for injection Current Sponsor code: gE Other descriptive name: gE recombinant protein Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50-
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Primary Outcome(s)
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Primary end point(s): 1)Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells at Months 48, 60 and 72 : Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-gamma) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-alpha) and/or CD40 Ligand (CD40L) secretion/expression to gE and VZV as determined by Intracellular Cytokine Staining (ICS) at Months 48, 60 and 72 for all subjects 2)Antigen-specific Antibody (Ab) concentrations at Months 48, 60 and 72:Anti-gE and anti-VZV Ab concentrations as determined by ELISA at Months 48, 60 and 72 for all subjects;
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Secondary Objective: 1)To evaluate the safety of the study vaccine in healthy elderly subjects (60-69 YOA and = 70 YOA) at Months 48, 60 and 72. 2)To collect basic clinical data on suspected cases of HZ
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Main Objective: To evaluate cell-mediated and humoral immune responses of the study vaccine in healthy elderly adults overall and within each age cohort (60-69 years of age [YOA] and = 70 YOA) at Months 48, 60 and 72.
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Results
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Results available:
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