E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary immunization of healthy elderly subjects (60 to 69 and more than or equal to 70 years) against zoster |
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MedDRA Classification |
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 |
The main objective of the trial is to compare the CD4 T cell response to gE of gE/AS01B study vaccines at Month 3 in healthy elderly subjects of more than or equal to 70 years of age (YOA). |
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E.2.2 | Secondary objectives of the trial |
1/ Compare the CD4 T cell response to gE between 100 mg gE/AS01B vaccine and 100 mg gE/saline vaccine at Month 3 in healthy elderly subjects > or = 70 YOA 2/ Compare the serological response to gE and VZV of gE/AS01B study vaccines at Month 3 in healthy elderly subjects > or = 70 YOA 3/ Evaluate the CD4/CD8 T cell response to gE after one and two injections of study vaccine formulations in healthy elderly subjects (60 to 69 YOA and > or = 70 YOA) 4/ Evaluate the serological response after one and two injections of study vaccine formulations in healthy elderly subjects (60 to 69 YOA and > or = 70 YOA) 5/ Evaluate the persistence of the cell-mediated and serological responses of study vaccine formulations at months 12, 24 and 36 6/ Evaluate the safety and reactogenicity of all study vaccine formulations in healthy elderly subjects (60 to 69 YOA and > or = 70 YOA) 7/ Evaluate the incidence of clinically diagnosed herpes zoster (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 that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study 2/ A male or female aged 60 years or older at the time of the first vaccination 3/ Written informed consent obtained from the subject
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E.4 | Principal exclusion criteria |
1/ Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period 2/ Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) 3/ Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection 4/ Previous administration of a vaccine containing MPL and/or QS21 5/ Previous vaccination against HZ 6/ History of herpes zoster (Shingles) 7/ Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required) 8/ History of allergic disease or reactions likely to be exacerbated by any component of the vaccine 9/ Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C (99.5°F)/Axillary temperature <37.5°C (99.5°F) 10/ Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject’s medical history or physical examination as assessed by the investigator 11/ Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period 12/ History of or current drug and/or alcohol abuse.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is frequencies of CD4 T cells with at least two antigen-specific cytokines (IFN-g, IL-2, TNF-a, CD40L) to gE as determined by intracellular cytokine staining (ICS) one month after the second vaccination (Month 3) in gE/AS01B study vaccine groups of more than or equal to 70 YOA 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
gE only, without adjuvant (gE/saline) |
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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 | 14 |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |