E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Evaluation of persistence of immune responses following immunisation of healthy elderly subjects (60-69 and ≥70 years) against Herpes Zoster (HZ) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019974 |
E.1.2 | Term | Herpes zoster |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
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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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the last study visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |