Vaccination against HZ and its related complications in adults older than 50 years (at the time of primary vaccination). MedDRA version: 20.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1 Level: PT Classification code 10030865 Term: Ophthalmic herpes zoster
Conditions
Interventions
Trade Name: SHINGRIX
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: NA
Current Sponsor code: gE
Other descriptive name: RECOMBINANT VARICELLA ZOSTER VIRUS
Sponsors
GlaxoSmithKline Biologicals
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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1356 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2306
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 |
|---|---|
| Main Objective: To evaluate the vaccine efficacy (VE) of HZ/su in preventing HZ.;Secondary Objective: • 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. ;Primary end point(s): Number of participants in LTFU and Control groups with confirmed HZ cases;Timepoint(s) of evaluation of this end point: During the total duration of ZOSTER-101 study (Day 1 through Month 48) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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-?, IL-2, TNF-a, 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 ;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) | — |
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 ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed