E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Herpes zoster [shingles] and post-herpetic neuralgia
Herpes Zóster y Neuralgia Postherpética
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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 |
To demonstrate that a second dose of Zostavax® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of Zostavax® whether given as a 0-1 month schedule or a 0-3 month schedule in subjects from 70 years of age as measured at 4 weeks post vaccination. |
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E.2.2 | Secondary objectives of the trial |
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 annually 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.
To assess the safety profile of a 1-dose regimen and the safety profile of each 2-doses regimen of Zostavax® adminsitered to subjects ≥ 70 years of age. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects will be included in this study if they meet all of the following 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 |
Subjects will not be included in the study if they meet any of the following non-inclusion criteria:
1. Febrile (oral temperature ≥ 38.3°C) 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 strictly greater than 1 hour of exposure indoors), or hospital contact (in same 2- to 4-bed 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 study 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 inpairment caused by medical condition (congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's 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 ≥5 mg/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 first 5 months prior to the first vaccination 13. Concomitant use of non-topical anti-viral 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
There are also a list of temporary contra-indications to further vaccination and definite contra-indications to further vaccination. See Study Protocol Section IV.3 and IV.4. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity
The primary criteria defined for immunogenicity are 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.
There are a number of secondary criteria defined for immunogenicity. See Study Protocol Section XI.1.2 for a listing of these [Evaluation criteria, Secondary criteria]. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
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 maximal follow-up duration will be of 36 months post last-dose. This period may be decreased after analyses of results 12 months post last-dose. |
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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 | 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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |