Herpes Zoster Clinical Trial
Official title:
Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GSK Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age
The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals' HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age
The study will evaluate the impact of HZ/su vaccination on the QoL, 400 adults ≥ 50 years of
age (YOA). Subjects will be asked to respond to a series of SF-36 and EQ-5D questionnaires
before and after vaccination following a 2 month schedule. To estimate the impact of
reactogenicity on an individual's physical functioning (PF) and QoL, the study will compare
subject questionnaire responses made during two periods, i.e., pre-vaccination and
post-vaccination. The difference will be considered to be the effect of vaccination and
reactogenicity on the PF and QoL. To characterize the study population and determine if
frailty may influence reactogenicity and consequently the impact on QoL scores, the subjects'
frailty status will be assessed at the first inclusion visit. In addition to the SF-36 and
EQ-5D questionnaires, a more complete characterization of the reactogenicity of the vaccine
will be made by including a detailed collection of the use of healthcare resources and the
occurrence of symptoms through diary card data collection. Impact on days of work loss, both
for the subject or for a caregiver, as applicable, will also be assessed.
Note that as a result of internal change in data standards terminology, the study data
collected was converted to cDISC and the statistical analysis plan was amended accordingly.
"Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by
"Day n+1". Thus, the timeframes (Day 0, Day n) of Outcome Measures described in this study
record are different to that denoted in the full protocol document posted.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03120364 -
Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
|
Phase 3 | |
| Completed |
NCT01165203 -
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
|
Phase 2 | |
| Recruiting |
NCT06088745 -
A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
|
Phase 3 | |
| Completed |
NCT01385566 -
A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
|
Phase 1 | |
| Completed |
NCT01137669 -
ZOSTAVAX® in Renal Transplant Patients
|
Phase 1 | |
| Completed |
NCT01911065 -
T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020
|
Phase 4 | |
| Completed |
NCT00550745 -
ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
|
Phase 4 | |
| Completed |
NCT01132729 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
|
N/A | |
| Completed |
NCT01132716 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
|
N/A | |
| Completed |
NCT00231816 -
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
|
Phase 3 | |
| Completed |
NCT02852876 -
Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
|
Phase 1 | |
| Completed |
NCT05082688 -
Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)
|
Phase 2 | |
| Completed |
NCT04099706 -
Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT
|
N/A | |
| Active, not recruiting |
NCT04091451 -
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles
|
Phase 3 | |
| Completed |
NCT02519855 -
Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)
|
Phase 3 | |
| Completed |
NCT04523246 -
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
|
Early Phase 1 | |
| Completed |
NCT05047770 -
A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine
|
Phase 3 | |
| Completed |
NCT03314103 -
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
|
Phase 3 | |
| Completed |
NCT01527370 -
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
|
Phase 3 | |
| Completed |
NCT01954251 -
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
|
Phase 3 |