An observational study in Herpes Zoster, Quality of Life and Immunization; Infection, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Observational
Among 16 studies in Herpes Zoster with a site in Spain — 2 open to participants now, 3 under way, 1 of them phase 3. Herpes Zoster · Spain.
Among the 16 studies in Herpes Zoster with a site in Spain, this one is the only one that started in 2024, is one of 3 observational ones, and was the 16th registered.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
Browse Herpes Zoster studies →2 of the 16 studies in Herpes Zoster with a site in Spain are open now. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Spain, Belgium, France and 3 more countries
Ages 1–17
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 37 Herpes Zoster studies recruiting now, 26 (70%) set no upper age limit and 6 (16%) stop at 75 or younger; 3 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 10
First in 2009; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 357 is above the median of 290 across 42 observational studies indexed under Herpes Zoster.
Median enrollment 568 across the 13 interventional studies, 552 across the 3 observational. Of the 13 that completed or were terminated, 12 (92%) have results posted.
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15 of 16 have an industry lead sponsor. The 2 most frequent:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 76 studies on the registry; 27 are open to participants now.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz has 1 study filed under Herpes Zoster — fewer than ten, so there is no comparison to draw.
1 of the studies in Herpes Zoster with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05371080Phase 3GlaxoSmithKlineA Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults | 2027-08-23 |
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Among the 16 studies in Herpes Zoster with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Title: Impact on quality of life and disease burden in adults with herpes zoster
Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3.
Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.
Impact on quality of life and disease burden in adults with herpes zoster Contents
HYPOTHESIS AND OBJECTIVES OF THE STUDY 3.1 Hypothesis: Herpes zoster significantly affects the quality of life of those who suffer from it with a high disease burden.
3.2 Primary outcomes: To measure the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Fundación Jiménez Díaz University Hospital.
3.3 Secondary outcomes
TYPE OF STUDY AND DESIGN
Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3.
Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.
SUBJECT SELECTION 5.1 Prospective cohort study Inclusion criteria Patients > 18 years of age who are to be immunised against HZ
Exclusion criteria:
ICD 9 053 Herpes zoster Includes:
Herpes zoster Zone 053.0 With meningitis 053.1 With other central nervous system complications 053.10 With unspecified nervous system complications 053.11 Geniculate herpes zoster or Herpetic geniculate ganglionitis 053.12 Postherpetic trigeminal neuralgia 053.13 Postherpetic polyneuropathy 053.14 Herpes zoster myelitis 053.19 Other 053.2 With ophthalmic complications 053.20 Herpes zoster dermatitis of eyelid or Herpes zoster ophthalmicus 053.21 Herpes zoster keraconjunctivitis 053.22 Herpes zoster iridocyclitis 053.29 Other 053.7 With other complications specific 053.71 Otitis externa due to herpes zoster 053.79 Other 053.8 With unspecified complications 053.9 Herpes zoster without complication Herpes zoster NOS ICD 10 B02 Herpes zoster Includes: - herpes - zone B02.0 Encephalitis due to herpes zoster Meningoencephalitis due to herpes zoster B02.1 Meningitis due to herpes zoster B02.2 Herpes zoster with other nervous system involvement B02.21 Postherpetic geniculate ganglionitis B02.22 Postherpetic trigeminal neuralgia B02.23 Postherpetic polyneuropathy B.02.24 Postherpetic myelitis or Herpes zoster myelitis B02.29 Other postherpetic nervous system involvement or Postherpetic radiculopathy B02.3 Ocular herpes zoster B02.30 Ocular herpes zoster, unspecified B02.31 Herpes zoster conjunctivitis B02.32 Herpes zoster iridocyclitis B02.33 Herpes zoster keratitis or Herpes zoster keratoconjunctivitis B02.34 Herpes zoster scleritis B02.39 Other herpes zoster eye diseases or Herpes zoster blepharitis B02.7 Disseminated herpes zoster B02.8 Herpes zoster with other complications Herpes zoster otitis externa B02.9 Uncomplicated herpes zoster Herpes zoster
Prospective study:
Patients > 18 years of age who are to be immunized against HZ
Retrospective study:
Adults over 18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation hospital.
Since the international classification of diseases changed from ICD 9 to ICD 10 in 2016, the codes to be used for the inclusion of patients in the study are described below.
Patients diagnosed with herpes zoster (HZ). Study Population and Total Number of Patients: Based on the sample calculation, it is intended to include a total of 357 patients in the prospective study and 1,920 patients in the retrospective study.
1 Prospective cohort study Inclusion criteria Patients > 18 years of age who are to be immunized against HZ
Exclusion criteria:
ICD 9 053 Herpes zoster
Includes:
Includes:
Exclusion criteria:
Patients who are vaccinated against HZV
Patients \> 18 years old who are going to be immunized against HZ
Quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.
Measuring the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.
Time frame: Data will be collected for 1 year and then analyzed to respond to the outcomes
Quality of life according to the location of herpes zoster
Evaluate quality of life according to the location of herpes zoster (postherpetic neuralgia, ophthalmic zoster, etc.)
Time frame: Data will be collected for 1 year and then analyzed to respond to the outcome
Effectiveness of the vaccine against herpes zoster
Evaluating the effectiveness of the herpes zoster vaccine in terms of the number of episodes, severity and quality of life.
Time frame: Data will be collected for 1 year and then analyzed to respond to the objective
Economic impact and disease burden in terms of morbidity and mortality
Economic impact and burden of disease in terms of morbidity and mortality of adult patients with herpes zoster
Time frame: A retrospective analysis will be carried out, when the data has been analysed this outcome will be answered, in approximately 6 months.
Plan to share: Undecided
Start is estimated for Nov 2024; primary completion for Nov 2025, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz