Herpes Zoster vaccine GSK1437173A
BiologicalIntramuscular injection
Other names: HZ/su
NCT Number: NCT02690207
The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).
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Notify Me50 year and older
All sexes
Interventional
Phase 3
GSK Investigational Site, Maroubra, New South Wales, Australia
Since the HZ/su vaccine has not yet been licensed and marketed, this study is being conducted to enable potentially eligible subjects who previously received placebo in ZOSTER-006 (NCT01165177) or ZOSTER-022 (NCT01165229) to receive the HZ/su vaccine.
Study ZOSTER-056 is an open-label, multi-centric and single arm study to cross-vaccinate and collect safety data in terms of of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and pIMD from subjects >= 50 YOA who previously received placebo.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular injection
Other names: HZ/su
Time frame: During 30 days (Days 0-29) after any vaccination (across doses)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related=AE assessed by the investigator as related to the vaccination.
Time frame: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related=SAE assessed by the investigator as related to the vaccination.
Time frame: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs=pIMDs assessed by the investigator as related to the vaccination.
Time frame: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
A suspected case of HZ was defined as a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations).
Clinically confirmed HZ episode is suspected HZ episode confirmed by the Investigator/Delegate.
GlaxoSmithKline
Industry
Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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