A Phase 3 interventional study of Herpes Zoster Vaccine GSK1437173A in Herpes Zoster, sponsored by GlaxoSmithKline. Completed at 195 sites in 18 countries. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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).
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.
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 8,687 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has agreed to continue adequate contraception during the entire treatment period* and for 2 months after completion of the vaccination series.
Exclusion Criteria:
Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm
Biological: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Also known as: HZ/su
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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: During 30 days (Days 0-29) after any vaccination (across doses)
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
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)
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
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)
Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s)
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.
Time frame: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Potentially eligible subjects who received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies were enrolled in this study.
| Milestone | HZ/su Group |
|---|---|
| Started | 8687 |
| Completed | 8434 |
| Not completed | 253 |
| Withdrew: Lost to follow-up | 48 |
| Withdrew: Withdrawal by subject | 46 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Serious adverse event | 110 |
| Withdrew: Non-serious adverse event | 18 |
| Withdrew: Migrated/moved from study area | 5 |
| Withdrew: Suspected hz episode | 1 |
| Withdrew: Other reasons for withdrawal | 23 |
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.
| Participants | HZ/su Group |
|---|---|
| Any AE(s) | 5175 |
| Grade 3 AE(s) | 963 |
| Related AE(s) | 4422 |
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.
| Participants | HZ/su Group |
|---|---|
| Any SAE(s) | 734 |
| Related SAE(s) | 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.
| Participants | HZ/su Group |
|---|---|
| Any pIMD(s) | 62 |
| Related pIMD(s) | 1 |
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.
| Participants | HZ/su Group |
|---|---|
| HZ episode | 30 |
| Suspected HZ episode only | 8 |
| Clinically confirmed HZ episode | 22 |
Collected over Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HZ/su Group | 107/8,687 (1.2%) | 734/8,687 (8.4%) | 5,101/8,687 (58.7%) |
| Event | HZ/su Group |
|---|---|
| PneumoniaInfections and infestations | 54/8687 |
| Cardiac failureCardiac disorders | 28/8687 |
| Atrial fibrillationCardiac disorders | 25/8687 |
| Acute myocardial infarctionCardiac disorders | 18/8687 |
| Myocardial infarctionCardiac disorders | 18/8687 |
| Urinary tract infectionInfections and infestations | 17/8687 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 15/8687 |
| Cardiac failure congestiveCardiac disorders | 14/8687 |
| Cerebrovascular accidentNervous system disorders | 14/8687 |
| Angina pectorisCardiac disorders | 12/8687 |
| Event | HZ/su Group |
|---|---|
| Injection site painGeneral disorders | 3173/8687 |
| Injection site erythemaGeneral disorders | 1311/8687 |
| PyrexiaGeneral disorders | 1038/8687 |
| Injection site swellingGeneral disorders | 928/8687 |
| HeadacheNervous system disorders | 678/8687 |
| MyalgiaMusculoskeletal and connective tissue disorders | 386/8687 |
| FatigueGeneral disorders | 384/8687 |
| ChillsGeneral disorders | 319/8687 |
| Injection site pruritusGeneral disorders | 248/8687 |
| NasopharyngitisInfections and infestations | 228/8687 |
| Age, Continuous(Years) | HZ/su Group |
|---|---|
| Mean | 72.6 ± 9.4 |
| Age, Customized(Participants) | HZ/su Group |
|---|---|
| Age 18-64 years | 2326 |
| Age 65-84 years | 5574 |
| Age 85 years and over | 787 |
| Sex/Gender, Customized(Participants) | HZ/su Group |
|---|---|
| Female | 5254 |
| Male | 3433 |
| Race/Ethnicity, Customized(Participants) | HZ/su Group |
|---|---|
| African Heritage/ African American | 72 |
| American Indian or Alaskan Native | 7 |
| Asian-Central/South Asian Heritage | 5 |
| Asian-East Asian Heritage | 1202 |
| Asian-Japanese Heritage | 254 |
| Asian-South East Asian Heritage | 12 |
| Native Hawaiian or Other Pacific Islander | 3 |
| White-Arabic/North African Heritage | 47 |
| White-Caucasian / European Heritage | 6361 |
| Other | 724 |
Showing the first 100 of 195 sites across 18 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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