E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of herpes zoster in adults with autoimmune disease |
Forebyggelse af herpes zoster i voksne med autoimmun sygdom |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of shingles in adults with an illness occurring when the body tissues are attacked by its own immune system |
Forebyggelse af helvedesild i voksne med en sygdom grundet at kroppens væv bliver angrebet af kroppens eget immunsystem |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019982 |
E.1.2 | Term | Herpes zoster NOS |
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 |
1) To determine whether V212 is immunogenic when administered to adult patients with autoimmune disease. 2) To assess the safety and tolerability of V212 in adult patients with autoimmune disease. |
1) at fastslå om V212 er immunogen, når det gives til voksne patienter med autoimmun sygdom. 2) at vurdere sikkerhed og tolerabilitet af V212 i voksne patienter med autoimmun sygdom. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient is ≥18 years of age with an autoimmune disease, has clinically stable disease for ≥30 days prior to enrollment, is receiving treatment with at least one biologic agent or non-biologic therapy at a stable dose for ≥3 months, 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, and is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose. |
Patienterne er ≥18 år med autoimmun sygdom, har klinisk stabil sygdom i ≥30 dage forud for indtræden i studiet, har modtaget behandling med mindst et biologisk eller non-biologisk præparat i stabil dosis i ≥3 måneder, har varicella i anamnese, antistoffer mod VZV eller bor i et land med endemisk VZV infektion i ≥30 år (hvis patienten er <30 år gammel: har gået i skole i et land med endemisk VZV infektion), usandsynlig at skulle gennemgå en hematopoietisk celle transplantation og højst usandsynlig vil blive gravid fra 2 uger før indtræden til 6 måneder efter sidste vaccinationsinjektion. |
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E.4 | Principal exclusion criteria |
Patient has a history of herpes zoster within 1 year of enrollment, has a history of receipt of any varicella or zoster vaccine, has or will receive treatment with any anti-CD20 monoclonal antibody within the time period from 3 months prior to enrollment through 28 days following the last dose of study vaccine, is likely to receive any live virus vaccine during the period from 4 weeks prior to enrollment through 28 days following the last dose of study vaccine, or is likely to receive any inactivated vaccine during the period from 7 days prior to, through 7 days following, any dose of study vaccine. |
Patient, som har haft H. Zoster indenfor 1 år fra indtræden, har modtaget varicella eller zoster vaccine af enhver art, har eller vil få behandling med ethvert anti-CD20 monoklonalt antistof indenfor en 3 måneders periode op til indtræden indtil 28 dage efter den sidste studievaccinedosis er givet, med sandsynlighed vil modtage enhver type virus vaccine med levedygtige virus i en periode fra 4 uger før indtræden til 28 dage efter sidste studievaccinedosis er givet eller vil modtage enhver type virus vaccine med inaktiveret virus i en periode fra 7 dage før indtræden til 7 dage efter en hvilken som helst af studievaccineinjektionerne er givet. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary immunogenicity endpoint is the GMFR of the VZV-specific immune responses from prevaccination to ~28 days Postdose 4. |
Det primære immunogenicitet endepunkt er GMFR af det VZV-specifikke immunrespons fra prevacctination til ~28 dage postdosis 4. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 (prior to Dose 1) and Visit 5 (28 days Postdose 4 [+7 days]) |
Dag 1 (før injektion 1) og besøg 5 (28 dage efter injektion 4 [+7 dage]) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 |
Immunologic response to vaccine |
Immunologisk respons på vaccine |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
Australia |
Belgium |
Canada |
Colombia |
Denmark |
Estonia |
Israel |
Netherlands |
New Zealand |
Peru |
Romania |
Spain |
Sweden |
United States |
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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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |