Herpes Zoster Clinical Trial
Official title:
Observational Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022 and HZ Efficacy, Immunogenicity and Safety of HZ/su by Frailty Status
As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study
participants completed quality of life (QoL) questionnaires. The only questionnaires encoded
into the data base were those from participants who developed a suspected shingles episode
during the study.
The purpose of this study is to allow for the encoding and analysis of questionnaires for all
subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of
subjects enrolled in these studies and to investigate whether this population is
representative of the general population.
As part of the study procedure, each subject enrolled in studies Zoster-006 and Zoster-022
was asked to complete two quality of life (QoL) questionnaires named respectively SF-36 and
EQ-5D at predefined study time points. These questionnaires were to provide relevant
information about the quality of life (functional status, ability to socialize, mental
health, etc.) of subjects before they develop shingles Extracting some elements of the
Quality of Life questionnaires (QoL), EQ-5D and SF-36, completed by all study subjects at
baseline, and combining them with other medical history data allows attributing of frailty
scores.
Analyses pertaining to efficacy, safety and immunogenicity as per frailty score might be
performed according to the methodology used in the ZOSTER-006 and ZOSTER-022 studies.
Additionally, the data collected can be used to assess if some physical, physiological and/or
psychological characteristics reported by the subjects before the onset of HZ would be
predictive of HZ.
;
| 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 |
NCT01911065 -
T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020
|
Phase 4 | |
| Completed |
NCT01137669 -
ZOSTAVAX® in Renal Transplant Patients
|
Phase 1 | |
| Completed |
NCT00550745 -
ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
|
Phase 4 | |
| Completed |
NCT01132716 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
|
N/A | |
| Completed |
NCT01132729 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting 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 |