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 | 9.1 |
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 assess the impact of ZOSTAVAX™ on the development of HZ in subjects 50 to 59 years of age. |
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E.2.2 | Secondary objectives of the trial |
To determine whether ZOSTAVAX™ is immunogenic when administered to subjects 50 to 59 years of age. To assess the overall safety and tolerability profile of ZOSTAVAX™ in subjects 50 to 59 years of age. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 50 to 59 years (at time of informed consent). 2. Signed an informed consent form prior to any study procedure. 3. Afebrile (<100.4°F [<38.0°C] oral or equivalent) on day of vaccination. 4. History of varicella or residence in a VZV-endemic area for ≥30 years. 5. Female subjects who are of reproductive potential must have a negative serum or urine pregnancy test and agree to remain abstinent, or use (or have their partner use) 2 acceptable methods of birth control for 3 months postvaccination.
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E.4 | Principal exclusion criteria |
1. A history of hypersensitivity reaction to any vaccine component, including gelatin or neomycin. 2. Prior receipt of any varicella or zoster vaccine. 3. Prior history of HZ. 4. Immunoglobulin or any blood products given 5 months prior to vaccination or expected during the 42 days after vaccination. 5. Any live virus vaccine administered within 4 weeks prevaccination or expected within 42 days postvaccination. 6. Any inactivated vaccine administered within 7 days prevaccination or expected within 7 days postvaccination. 7. Subject is pregnant or breastfeeding. 8. Participation in a clinical study with administration of an investigational drug or vaccine within the last 30 days prior to enrollment. 9. An intercurrent illness that might interfere with the interpretation of the study. 10. Use of immunosuppressive therapy. 11. Known or suspected immune dysfunction. 12. Any concomitant use of nontopical antiviral therapy.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the incidence of HZ in the vaccine and placebo groups, defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. This will be an event-driven study. Subjects will be followed in the study for occurrences of HZ for approximately 1 year or longer, depending on the time required to accrue 96 confirmed cases.
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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 | No |
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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | 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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Subjects will be followed in the study for occurrences of HZ, depending on the time required to accrue 96 confirmed cases of HZ. At that time, no additional suspected HZ cases will be accrued, and subjects already entered in suspected HZ case follow-up will continue until completion of scheduled ZBPI and WPQ surveys. All subjects enrolled in the study will be contacted by the Study Coordinator to complete study close-out. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |