E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Herpes zoster and post-herpetic neuralgia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019974 |
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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 demonstrate that a second dose of ZOSTAVAX elicits higher varicella-zostervirus (VZV) antibody titers than first dose of ZOSTAVAX whether given a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at weeks 4 post-vaccination |
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E.2.2 | Secondary objectives of the trial |
Immunogenicity To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX administered to subjects ≥70 years of age To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX administered to subjects ≥70 years of age To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX administered to subjects ≥70 years of age Safety To assess the safety profile of a 1-dose regimen and the safety profile of each 2-doses regimen of Zostavax administered to subjects ≥70 years of age |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Age ≥ 70 years 2. Varicella history-positive or residence for > 30 years in a country with endemic VZV infection 3. Signed informed consent form prior to any study procedure |
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E.4 | Principal exclusion criteria |
1. Febrile (oral temperature ≥ 38.3C) within the last 72 hours before the first vaccination 2. History of hypersensitivity/ anaphylactoid reaction to ZOSTAVAX components including gelatin or neomycin 3. Prior herpes-zoster episode clinically diagnosed by a physician 4. Prior receipt of varicella or zoster vaccine 5. Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination by continuous household contact, or non-household contact (generally >1 hour of exposure indoors), or hospital contact (in same 2- to 4-beds room or adjacent beds in a large ward or face-to-face contact with an infectious staff member or subject), or contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery 6. Significant underlying illness preventing completion of the vaccination schedules 7. Known active tuberculosis 8. Immune deficiency disorder, including active neoplastic disease (except local skin cancer) within the prior 5 years 9. Immune function impairment caused by medical condition (congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkins disease, multiple myeloma, generalised malignancy), or immunosuppressive therapy (examples: chemotherapy agents to treat cancer, treatments associated with organ or bone marrow transplantation, daily (or on alternate days) systemic corticosteroids at a dose ≥5mg/day prednisone equivalent for at least 14 days in the 4 weeks prior to the first vaccination), or any other cause 10. Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination 11. Receipt of any other live vaccine within the 4 weeks prior to the first vaccination 12. Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination 13. Concomitant use of non-topical antiviral therapy (examples: acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, cidofovir, brivudine) 14. History of alcohol or recreational drug abuse which in the opinion of the investigator could interfere with study compliance 15. Any other condition / situation that in the opinion of the investigator could interfere with the interpretation of the study, including possible interference caused by acute intercurrent illness (examples: upper respiratory infection, influenza), or any other cause 16. Participation to any other clinical study that includes an investigational product within the 4 weeks prior to the first vaccination or planned during the duration of the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The 4 weeks post-dose 1 and 4 weeks post-dose 2 VZV antibody titres (i.e. GMT in gpELISA units/mL) in group 2 and in group 3 |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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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 | 8 |
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 | 8 |