Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.
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|ClinicalTrials.gov Identifier: NCT02690207|
Recruitment Status : Completed
First Posted : February 24, 2016
Results First Posted : March 12, 2020
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster||Biological: Herpes Zoster Vaccine GSK1437173A||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8687 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 16, 2016|
|Actual Primary Completion Date :||March 15, 2019|
|Actual Study Completion Date :||March 15, 2019|
Experimental: HZ/su Group
Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm
Biological: Herpes Zoster Vaccine GSK1437173A
Other Name: HZ/su
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ 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.
- Number of Subjects With Any and Related Serious Adverse Events (SAEs) [ 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.
- Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) [ 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.
- Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s) [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690207
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|