E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 |
Main objective: To determine whether ZOSTAVAX™ [zoster vaccine live (Oka/Merck)] has acceptable safety profile when administered to patients who are receiving chronic/maintenance corticosteroid therapy.
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E.2.2 | Secondary objectives of the trial |
Secondary objective: To determine whether ZOSTAVAX™ [zoster vaccine live (Oka/Merck)] is immunogenic when administered to patients who are receiving chronic/maintenance corticosteroid therapy.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age≥60 years. 2. A history of varicella or long-term residence in a country with endemic VZV infection. 3. Receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone or equivalent for at least 2 weeks immediately prior to enrolment. 4. Expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week duration of the study (dose may vary within this range during the 6-week postvaccination period). 5. All females mst be postmenopausal or have a negative serum or urine pregnancy test. A patient who is reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, oral contraceptive pills, condom, tubal ligation and vasectomy. 6. Signed consent form prior to any study procedure. 7. Any underlying chronic illness, including the condition for which the patient is receiving corticosteroids, must be in stable condition.
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E.4 | Principal exclusion criteria |
1. A histroy of allergic reaction to any vaccine component (including gelatin), or an anaphylactic/anaphylactoid reaction to neomycin (note that patients with history of contact dermatitis from neomycin may receive the vaccine.) 2. Prior history of HZ 3. Prior receipt of any varicella or zoster vaccine. 4. Women who are pregnant or breast feeding or planning to conceive within projected duration of the study. 5. Any use in the 8 weeks prior to vaccination or expected for 6 weeks postvaccination of concomitant immunosuppressive medications (e.g. corticosteroids >20 mg daily, chemotherapeutic agents, immunomodulating drugs, immunosuppressive treatments associated with solid organ or bone marrow transplantation. 6. Known or suspected immune dysfunction that is casued by a medical condition (other than that for which patient is receiving corticosteroid therapy), or any cause. 7. Immunoglobulin or any blood products, other than autologous blood tranfusion, given during the 5 months prior to vaccination or expected during the 6-week postvaccination period. 8. Any other live virus vaccine administered or scheduled from 4 weeks prior to vaccination or expected during the 6 week primary safety follow-up period. 9. Any inactivated vaccine adminsitered or scheduled in the period from 7 days prior to vaccination or expected during the 6-week primary safety follow-up period. 10. participation in an investigational drug or vaccine study within the last 30 days prior to enrollment and for 6-month safety follow-up period. 11. Any acute intercurrent illness that might interfere with the study such as unstable systemic lupus ewrythmetosus or unstable multiple sclerosis. 12. Significant underlying illness preventing completion of the study. 13. Any concomitatn use of nontopical antiviral therapy with activity against herpesviruses, including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscaernet and cidofovir. 14. a history of alcohol abuse or recreational drug use, which, in the opinion of the investigator, will interfere with study participation.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 | Yes |
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 | 0 |
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 | 0 |
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 |