E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination against HZ and its related complications in adults older than 50 years (at the time of primary vaccination). |
Vacunación frente al HZ y sus complicaciones relacionadas en adultos mayores de 50 años (en el momento de la primovacunación). |
|
E.1.1.1 | Medical condition in easily understood language |
Herpes zoster (Shingles) disease. |
Enfermedad del herpes zóster (culebrilla). |
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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 | 20.0 |
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036376 |
E.1.2 | Term | Post herpetic neuralgia |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030865 |
E.1.2 | Term | Ophthalmic herpes zoster |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063491 |
E.1.2 | Term | Herpes zoster oticus |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10075611 |
E.1.2 | Term | Varicella zoster virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10074297 |
E.1.2 | Term | Herpes zoster cutaneous disseminated |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10080516 |
E.1.2 | Term | Herpes zoster reactivation |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10084396 |
E.1.2 | Term | Disseminated varicella zoster virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10072210 |
E.1.2 | Term | Genital herpes zoster |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061208 |
E.1.2 | Term | Herpes zoster infection neurological |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10074259 |
E.1.2 | Term | Herpes zoster meningitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10074248 |
E.1.2 | Term | Herpes zoster meningoencephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10074243 |
E.1.2 | Term | Varicella zoster oesophagitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10074254 |
E.1.2 | Term | Varicella zoster pneumonia |
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 evaluate the vaccine efficacy (VE) of HZ/su in preventing HZ. |
Evaluar la eficacia vacunal (VE) de HZ/su en la prevención de HZ. |
|
E.2.2 | Secondary objectives of the trial |
• To evaluate the VE of HZ/su in preventing HZ from 1-month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study. • To evaluate persistence of the humoral immune response to HZ/su. • To evaluate persistence of the cell-mediated immune response to HZ/su. • To evaluate vaccine safety of HZ/su. |
• Evaluar la VE de HZ/su en la prevención de HZ desde 1 mes después de la dosis 2 en los estudios ZOSTER-006/022 hasta el final del estudio ZOSTER-101. • Evaluar la persistencia de la respuesta inmune humoral a HZ/su. • Evaluar la persistencia de la respuesta inmune mediada por células frente a HZ/su. • Evaluar la seguridad vacunal de HZ/su. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Participants and participant’s caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol. • Written or witnessed/thumb printed informed consent obtained from the participant of the participant prior to performance of any study-specific procedure. • Medically stable participants as established by medical history and clinical examination before entering into the study. • Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies). |
• Los participantes y el cuidador del participante, que, en opinión del investigador, pueden y están dispuestos a cumplir con los requisitos del protocolo. • Consentimiento informado por escrito o presenciado/impreso con el pulgar obtenido del participante antes de la realización de cualquier procedimiento específico del estudio. • Participantes médicamente estables según lo establecido por el historial médico y el examen clínico antes de ingresar al estudio. • Participantes que completaron el estudio ZOSTER-049 (después de al menos 1 dosis de HZ/su en los estudios ZOSTER-006/022). |
|
E.4 | Principal exclusion criteria |
Medical conditions • Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior/Concomitant therapy • Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period. • Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than HZ/su administered in studies ZOSTER-006/022 or ZOSTER-049).
Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV. |
Condiciones médicas • Cualquier condición clínica que, a juicio del investigador, pueda suponer un riesgo adicional para el participante debido a su participación en el estudio.
Terapia previa/concomitante • Uso de cualquier producto en investigación o no registrado (medicamento, vacuna o dispositivo médico) para el tratamiento de la infección por HZ o el virus de la varicela zoster (VZV) en el momento de la inscripción o su uso planificado durante el período de estudio. • Vacunación previa contra VZV o HZ y/o administración planificada durante el estudio de una vacuna contra VZV o HZ (incluida una vacuna en investigación o no registrada distinta de HZ/su administrada en los estudios ZOSTER-006/022 o ZOSTER-049).
Experiencia previa/concurrente en estudios clínicos • Participar simultáneamente en otro estudio clínico, en cualquier momento durante el período del estudio, en el que el participante ha estado o estará expuesto a una intervención en investigación o no en investigación (medicamento/dispositivo médico invasivo) para la prevención y/o tratamiento de HZ o VZV y que pueden tener una posible actividad contra VZV. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of participants in LTFU and Control groups with confirmed HZ cases |
Número de participantes en los grupos LTFU y Control con casos confirmados de HZ |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the total duration of ZOSTER-101 study (Day 1 through Month 48) |
Durante la duración total del estudio ZOSTER-101 (Día 1 al Mes 48) |
|
E.5.2 | Secondary end point(s) |
1. Number of participants in LTFU and Control groups with confirmed HZ cases 2. Anti-glycoprotein E (gE) antibody concentrations 3. Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-γ, IL-2, TNF-α, CD40L 4. Percentage of participants with serious adverse events (SAEs) causally related to the study intervention 5. Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention 6. Percentage of participants with HZ-related complications of confirmed HZ |
1. Número de participantes en los grupos LTFU y Control con casos confirmados de HZ 2. Concentraciones de anticuerpos anti-glucoproteína E (gE) 3. Frecuencia de linfocitos T de grupo de diferenciación (CD) 4+ específicos de gE que secretan al menos dos marcadores de activación entre IFN-γ, IL-2, TNF-α, CD40L 4. Porcentaje de participantes con eventos adversos graves (AAG) causalmente relacionados con la intervención del estudio 5. Porcentaje de participantes con posibles enfermedades inmunomediadas (pIMD, por sus siglas en inglés) (graves y no graves) relacionadas causalmente con la intervención del estudio 6. Porcentaje de participantes con complicaciones relacionadas con HZ de HZ confirmado |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48 2, 3. At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study 4, 5, 6. During the total duration of the ZOSTER-101 study (Day 1 through Month 48) |
1. Desde 1 mes después de la dosis 2 en los estudios ZOSTER-006/022 hasta el final del estudio ZOSTER-101 en el mes 48 2, 3. En el día 1, meses 12, 24, 36 y 48 en el estudio ZOSTER-101 4, 5, 6. Durante la duración total del estudio ZOSTER-101 (Día 1 al Mes 48) |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity |
Inmunogenicidad |
|
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
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 | Yes |
E.8.2.3.1 | Comparator description |
Eficacia vacunal-Control histórico; Inmunogenicidad, seguridad para grupos aleatorizados, sin interv |
Vaccine efficacy-Historical Control; Immunogenicity, safety for randomized groups-no intervention |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 68 |
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 |
Brazil |
Canada |
Hong Kong |
Japan |
Korea, Republic of |
Mexico |
Taiwan |
United States |
Estonia |
Finland |
France |
Sweden |
Spain |
Czechia |
Germany |
Italy |
United Kingdom |
|
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
|
LSLV (Visit 5) or Date of the last testing/reading released of the Human Biological Samples or imaging data, related to primary and secondary endpoints, whichever comes later. EoS must be achieved no later than 8 months after LSLV. |
LSLV (Visita 5) o Fecha de la última prueba/lectura publicada de las Muestras biológicas humanas o datos de imágenes, relacionados con los criterios de valoración primarios y secundarios, lo que ocurra más tarde. La EoS debe lograrse a más tardar 8 meses después de la LSLV. |
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | 8 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 8 |