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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005319-30 | EudraCT Number |
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The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTFU Group | Other | Participants who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and are followed for long-term vaccine efficacy and safety in the current ZOSTER-101 study. |
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| 1-Additional Dose Group | Other | Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and one additional dose of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study. |
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| Revaccination Group | Other | Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and two additional doses of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study. |
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| Control Group | Other | Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the ZOSTER-049 study, but who served as a control for the two groups that received 1 or 2 additional doses of HZ/su (1-Additional Dose and Revaccination groups). In the current ZOSTER-101 study, this Control group is used in the evaluation of the long-term vaccine efficacy, safety and as a control for persistence of immunogenicity to additional doses administered in ZOSTER-049 study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HZ/su vaccine | Biological | No study intervention is administered in this extension study. Participants received the HZ/su vaccine administered in the ZOSTER-049 (NCT02723773), ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies. In order to assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment. In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants in LTFU and Control groups with confirmed HZ cases | A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed in two ways:
| During the total duration of ZOSTER-101 study (Day 1 through Month 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants in LTFU and Control groups with confirmed HZ cases | A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed in two ways:
| From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48 |
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Inclusion Criteria:
Exclusion Criteria:
Medical conditions
Prior/Concomitant therapy
Prior/Concurrent clinical study experience
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85020 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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Interventional study model and allocation in the current study follow the same approach as presented in the primary studies.
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| Anti-glycoprotein E (gE) antibody concentrations | Anti-gE antibody concentrations are expressed as geometric mean concentrations (GMCs), as determined by enzyme-linked immunosorbent assay (ELISA). | At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study |
| Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-γ, IL-2, TNF-α, CD40L | At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study |
| Percentage of participants with serious adverse events (SAEs) causally related to the study intervention | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity. Relationship between study intervention and the occurrence of SAEs is assessed by the investigator using clinical judgement. | During the total duration of the ZOSTER-101 study (Day 1 through Month 48) |
| Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention | pIMDs are a subset of adverse events of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. A serious pIMD is any pIMD that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity. Relationship between study intervention and the occurrence of pIMDs is assessed by the investigator using clinical judgement. | During the total duration of the ZOSTER-101 study (Day 1 through Month 48) |
| Percentage of participants with HZ-related complications of confirmed HZ | A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed in two ways:
| During the total duration of the ZOSTER-101 study (Day 1 through Month 48) |
| Elkridge |
| Maryland |
| 21075 |
| United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Hickory | North Carolina | 28601 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Bristol | Tennessee | 37620 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84106 | United States |
| GSK Investigational Site | Warrawong | New South Wales | 2502 | Australia |
| GSK Investigational Site | Westmead | New South Wales | 2145 | Australia |
| GSK Investigational Site | Geelong | Victoria | 3220 | Australia |
| GSK Investigational Site | Belo Horizonte | Minas Gerais | 30150-320 | Brazil |
| GSK Investigational Site | Curitiba | Paraná | 80069-900 | Brazil |
| GSK Investigational Site | São Paulo | 04266-010 | Brazil |
| GSK Investigational Site | São Paulo | 05403-000 | Brazil |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| GSK Investigational Site | Victoria | British Columbia | V8R 6R3 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 6R8 | Canada |
| GSK Investigational Site | Truro | Nova Scotia | B2N1L2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4S 1Y2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Mirabel | Quebec | J7J 2K8 | Canada |
| GSK Investigational Site | Québec | Quebec | G1E 7G9 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1J 2G2 | Canada |
| GSK Investigational Site | Brno | 612 00 | Czechia |
| GSK Investigational Site | České Budějovice | 370 05 | Czechia |
| GSK Investigational Site | Hradec Králové | 500 05 | Czechia |
| GSK Investigational Site | Tallinn | 13619 | Estonia |
| GSK Investigational Site | Tartu | 50106 | Estonia |
| GSK Investigational Site | Espoo | 02230 | Finland |
| GSK Investigational Site | Helsinki | 00100 | Finland |
| GSK Investigational Site | Helsinki | 00930 | Finland |
| GSK Investigational Site | Jarvenpaa | 04400 | Finland |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Oulu | 90220 | Finland |
| GSK Investigational Site | Pori | 28100 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Angers | 49000 | France |
| GSK Investigational Site | Clermont-Ferrand | 63003 | France |
| GSK Investigational Site | Laval | 53000 | France |
| GSK Investigational Site | Mûrs-Erigné | 49610 | France |
| GSK Investigational Site | Rosiers-d'Égletons | 19300 | France |
| GSK Investigational Site | Wangen | Baden-Wurttemberg | 88239 | Germany |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Rednitzhembach | Bavaria | 91126 | Germany |
| GSK Investigational Site | Wallerfing | Bavaria | 94574 | Germany |
| GSK Investigational Site | Flörsheim | Hesse | 65439 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51069 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45355 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45359 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58455 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55116 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01097 | Germany |
| GSK Investigational Site | Freiberg | Saxony | 09599 | Germany |
| GSK Investigational Site | Magdeburg | Saxony-Anhalt | 39112 | Germany |
| GSK Investigational Site | Berlin | 10787 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | Hamburg | 22415 | Germany |
| GSK Investigational Site | Shatin | 000000 | Hong Kong |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Fukuoka | 810-0021 | Japan |
| GSK Investigational Site | Fukuoka | 812-0025 | Japan |
| GSK Investigational Site | Fukuoka | 813-8588 | Japan |
| GSK Investigational Site | Fukuoka | 816-0864 | Japan |
| GSK Investigational Site | Kanagawa | 224-8503 | Japan |
| GSK Investigational Site | Tokyo | 142-8666 | Japan |
| GSK Investigational Site | Durango | 34000 | Mexico |
| GSK Investigational Site | Ansan | 425-707 | South Korea |
| GSK Investigational Site | Bucheon-si | 420-767 | South Korea |
| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Kangwon-do | 220-701 | South Korea |
| GSK Investigational Site | Seoul | 150-950 | South Korea |
| GSK Investigational Site | Seoul | 152-703 | South Korea |
| GSK Investigational Site | Balenyà (Barcelona) | 08550 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 8025 | Spain |
| GSK Investigational Site | Centelles (Barcelona) | 08540 | Spain |
| GSK Investigational Site | La Roca del Vallès | 08430 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Majadahonda( Madrid | 28222 | Spain |
| GSK Investigational Site | Marid | 28040 | Spain |
| GSK Investigational Site | Peralada( Girona) | 17491 | Spain |
| GSK Investigational Site | Valencia | 46020 | Spain |
| GSK Investigational Site | Vic | 28500 | Spain |
| GSK Investigational Site | Borås | SE-506 30 | Sweden |
| GSK Investigational Site | Gothenburg | SE-413 45 | Sweden |
| GSK Investigational Site | Karlskrona | Sweden |
| GSK Investigational Site | Linköping | SE-58758 | Sweden |
| GSK Investigational Site | Malmö | SE-211 52 | Sweden |
| GSK Investigational Site | Örebro | SE-703 62 | Sweden |
| GSK Investigational Site | Stockholm | Sweden |
| GSK Investigational Site | Upplands Vasby | SE-194 61 | Sweden |
| GSK Investigational Site | Uppsala | SE-751 85 | Sweden |
| GSK Investigational Site | Taichung | 40447 | Taiwan |
| GSK Investigational Site | Taipei | 10002 | Taiwan |
| GSK Investigational Site | Taipei | 112 | Taiwan |
| GSK Investigational Site | Taoyuan County | 333 | Taiwan |
| GSK Investigational Site | Buckshaw Village, Chorley | Lancashire | PR7 7NA | United Kingdom |
| GSK Investigational Site | Bradford-on-Avon | Wiltshire | BA15 1DQ | United Kingdom |
| GSK Investigational Site | Belfast | BT7 2EB | United Kingdom |
| GSK Investigational Site | Broughshane | BT42 4JP | United Kingdom |
| GSK Investigational Site | Liverpool | L22 0LG | United Kingdom |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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