Herpes zoster (Shingles) disease.
Conditions
Interventions
-Participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment.
-In case of a suspected HZ case diagnos
Sponsors
Ogawa Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants in LTFU and Control groups with confirmed HZ cases | — |
Secondary
| Measure | Time frame |
|---|---|
| -Number of participants in LTFU and Control groups with confirmed HZ cases. -Anti-glycoprotein E (gE) antibody concentrations -Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-gamma, IL-2, TNF-alpha, CD40L -Percentage of participants with serious adverse events (SAEs) causally related to the study intervention | — |
Countries
Australia, Brazil, Canada, Czechia, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Korea,Republic of, Mexico, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactMasayuki Ogawa
GlaxoSmithKline K.K.
Outcome results
None listed