Herpes Zoster
Conditions
Brief summary
Confirmed HZ cases during the total duration of the ZOSTER-101 study (Day 1 through Month 48).
Detailed description
Confirmed HZ cases since 1-month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER- 101 study., Anti-gE antibody concentrations at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study., Frequency of gE-specific CD4+ T-cells secreting at least 2 activation markers (from among IFN-γ, IL-2, TNF-α, CD40L) at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study., Number and percentage of participants with SAEs which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER-101 study (Day 1 through Month 48)., Number and percentage of participants with pIMDs (serious and non-serious) which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER- 101 study (Day 1 through Month 48)., Number and percentage of participants with HZ-related complications of confirmed HZ during the total duration of the ZOSTER-101 study (Day 1 through Month 48).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed HZ cases during the total duration of the ZOSTER-101 study (Day 1 through Month 48). | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmed HZ cases since 1-month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER- 101 study., Anti-gE antibody concentrations at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study., Frequency of gE-specific CD4+ T-cells secreting at least 2 activation markers (from among IFN-γ, IL-2, TNF-α, CD40L) at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study., Number and percentage of participants with SAEs which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER-101 study (Day 1 through Month 48)., Number and percentage of participants with pIMDs (serious and non-serious) which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER- 101 study (Day 1 through Month 48)., Number and percentage of participants with HZ-related complications of confirmed HZ during the total duration of the ZOSTER-101 study (Day 1 through Month 48). | — |
Countries
Czechia, Estonia, Finland, France, Germany, Italy, Spain, Sweden