E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019974 |
E.1.2 | Term | Herpes zoster |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 safety and tolerability of V212 (inactivated VZV vaccine) in adults with solid tumor or hematologic malignancy and to assess the impact of inactivated VZV vaccine on the development of HZ in adults with solid tumor or hematologic malignancy |
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E.2.2 | Secondary objectives of the trial |
To assess the impact of inactivated VZV vaccine on: 1) the development of V212 in adults with STM; 2) the development of V212 in adults with HM; 3)the development of moderate to severe HZ-associated pain at any time from HZ onset through the end of the 6 month HZ follow-up period; 4) the development of HZ complications, and 5) the development of PHN. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ELISPOT Substudy will enroll a subset of patients (~1000 patients of the total ~5136) to measure immune response by interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay.
To assess the immunogenicity of V212 in adults with STM or HM. |
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E.3 | Principal inclusion criteria |
Patient is ≥18 years of age with a solid tumor or hematologic malignancy receiving immunosuppressive or cytotoxic chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.
Patient is ≥50 years of age with a hematologic malignancy not in remission, may or may not be receiving chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years, is not likely to undergo hematopoietic cell transplant is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.
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E.4 | Principal exclusion criteria |
Patient has a prior history of HZ within 1-year of enrolment, a prior history of receipt of any varicella or zoster vaccine, is likely to undergo hematopoietic cell transplant and is likely to receive long term antiviral prophylaxis (greater than 4 weeks duration) with activity against varicella-zoster virus zoster, cytomegalovirus, or herpes simplex virus. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary clinical efficacy endpoint is the incidence of herpes zoster. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
First interim analysis approximately 3 years after enrollment begins; second interim analysis approximately 4 years after enrollment begins; final analysis approximately 5 years after enrollment begins. |
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E.5.2 | Secondary end point(s) |
Vaccination with V212 will reduce the incidence of HZ compared with placebo in adults with STM.
Vaccination with V212 will reduce the incidence of HZ compared with placebo in adults with HM.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
First interim analysis approximately 3 years after enrollment begins; second interim analysis approximately 4 years after enrollment begins; final analysis approximately 5 years after enrollment begins. |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 57 |
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 | No |
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 |
Argentina |
Australia |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
Colombia |
Croatia |
Czech Republic |
Ecuador |
Estonia |
France |
Germany |
Greece |
Guatemala |
Honduras |
Hong Kong |
India |
Italy |
Korea, Republic of |
Lebanon |
Lithuania |
Mexico |
New Zealand |
Panama |
Peru |
Philippines |
Romania |
Russian Federation |
Saudi Arabia |
Singapore |
Slovakia |
South Africa |
Spain |
Taiwan |
Turkey |
United Arab Emirates |
United Kingdom |
United States |
Jordan |
Venezuela, Bolivarian Republic of |
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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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Patients will remain in the study from the time of enrollment until accrual of the targeted number (~226) of confirmed HZ cases, with a minimum of 72 and 94 confirmed HZ cases in the STM and HM populations, respectively. This study plan may be modified as depending on the results of pre-specified interim analyses. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |