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Herpes ZosterNCT03563183

A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022

An observational study of Herpes Zoster, run by GlaxoSmithKline at 169 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Herpes Zoster
What is being tested?
Encoding of data collected in Zoster 006 and Zoster 022 studies
Type of treatment
Vaccines
How many people
26,976 participants
Where
169 sitesin 18 countries
Study dates
5 Jun 2018to 30 Apr 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All subjects enrolled in the Zoster 006 and Zoster 022 studies

Who may be able to join

  • All subjects who participated in the Zoster 006 and Zoster 022 trials.
  • Subjects who died or were lost to follow-up during ZOSTER-006 and ZOSTER-022 will be considered for enrolment in ZOSTER-064 and their data/questionnaires up to that point will be used.

Who cannot join

  • Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER-022. This will include any subject eliminated following deviations from GCP compliance.
  • Subjects who developed a suspected HZ case during ZOSTER-006 and ZOSTER-022 (since their QoL questionnaires were encoded in the eCRF for ZOSTER-006 and ZOSTER-022).

Trial locations and contacts

169 sites in 18 countries.

169 sites in 18 countries

Germany36 sites

  • GSK Investigational Site

    Berlin, 10629

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 13347

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Dachau, Bavaria, 85221

  • GSK Investigational Site

    Deggingen, Baden-Wurttemberg, 73326

  • GSK Investigational Site

    Dresden, Saxony, 01097

  • GSK Investigational Site

    Duelmen, Lower Saxony, 48249

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45355

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Flörsheim, Hesse, 65439

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Freiberg, Saxony, 09599

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Güglingen, Baden-Wurttemberg, 74363

  • GSK Investigational Site

    Hamburg, 20251

  • GSK Investigational Site

    Hamburg, 22143

  • GSK Investigational Site

    Hamburg, 22415

  • GSK Investigational Site

    Künzing, Bavaria, 94550

  • GSK Investigational Site

    Leipzig, Saxony, 04315

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23554

  • GSK Investigational Site

    Magdeburg, 39120

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Pirna, Saxony, 01796

  • GSK Investigational Site

    Rednitzhembach, Bavaria, 91126

  • GSK Investigational Site

    Rhaunen, Rhineland-Palatinate, 55624

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72074

  • GSK Investigational Site

    Wallerfing, Bavaria, 94574

  • GSK Investigational Site

    Wangen, Baden-Wurttemberg, 88239

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

Other trials in Germany

United States31 sites

  • GSK Investigational Site

    Beachwood, Ohio, 44122

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Cary, North Carolina, 27518

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Clearwater, Florida, 33761

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Meridian, Idaho, 83642

  • GSK Investigational Site

    Mesa, Arizona, 85213

  • GSK Investigational Site

    Mt Pleasant, North Carolina, 29464

  • GSK Investigational Site

    Murray, Utah, 84123

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Phoenix, Arizona, 85018

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Pleasant Hills, Pennsylvania, 15236

  • GSK Investigational Site

    Renton, Washington, 98057

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Spring Valley, California, 91978

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    Wadsworth, Ohio, 44281

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winchester, Virginia, 22601

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada14 sites

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 6R8

  • GSK Investigational Site

    Mirabel, Quebec, J7J 2K8

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • GSK Investigational Site

    Québec, Quebec, G1E 7G9

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 2G2

  • GSK Investigational Site

    Toronto, Ontario, M4S 1Y2

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3M9

  • GSK Investigational Site

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

France14 sites

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Angers, 49100

  • GSK Investigational Site

    Château-Gontier, 53200

  • GSK Investigational Site

    Cherbourg, 50100

  • GSK Investigational Site

    Clermont-Ferrand, 63003

  • GSK Investigational Site

    Laval, 53000

  • GSK Investigational Site

    Montrevault, 49110

  • GSK Investigational Site

    Muret, 31600

  • GSK Investigational Site

    Mûrs-Erigné, 49610

  • GSK Investigational Site

    Nantes, 44277

  • GSK Investigational Site

    Rosiers-d'Égletons, 19300

  • GSK Investigational Site

    Saint-Cyr-sur-Loire, 37540

  • GSK Investigational Site

    Segré, 49500

  • GSK Investigational Site

    Tours, 37100

Other trials in France

Spain12 sites

  • GSK Investigational Site

    Alcover( Tarragona), 43460

  • GSK Investigational Site

    Balenyà (Barcelona), 08550

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Centelles (Barcelona), 08540

  • GSK Investigational Site

    La Roca Del Valles (Barcelona), 08430

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Majadahonda( Madrid, 28222

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Peralada( Girona), 17491

  • GSK Investigational Site

    Valencia, 46020

  • GSK Investigational Site

    Vic/ Barcelona, 08500

Other trials in Spain

Sweden10 sites

  • GSK Investigational Site

    Borås, SE-506 30

  • GSK Investigational Site

    Eskilstuna, SE-631 88

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Jönköping, SE-551 85

  • GSK Investigational Site

    Karlskrona, SE-371 41

  • GSK Investigational Site

    Linköping, SE-581 85

  • GSK Investigational Site

    Malmö, SE-211 52

  • GSK Investigational Site

    Örebro, SE-703 62

  • GSK Investigational Site

    Uppsala, SE-751 85

  • GSK Investigational Site

    Vällingby, SE-162 68

Other trials in Sweden

South Korea8 sites

  • GSK Investigational Site

    Gangwon-do, 26426

  • GSK Investigational Site

    Gyeonggi-do, 14584

  • GSK Investigational Site

    Gyeonggi-do, 15355

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Seoul, 06273

  • GSK Investigational Site

    Seoul, 06351

  • GSK Investigational Site

    Seoul, 07441

  • GSK Investigational Site

    Seoul, 08308

Other trials in South Korea

Italy7 sites

  • GSK Investigational Site

    Chieti, Abruzzo, 66013

  • GSK Investigational Site

    Cuneo, Piedmont, 12100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Monza, Lombardy, 20900

  • GSK Investigational Site

    Pescara, Abruzzo, 65100

  • GSK Investigational Site

    Rome, Lazio, 00133

  • GSK Investigational Site

    Rome, Lazio, 00163

Other trials in Italy

Japan7 sites

  • GSK Investigational Site

    Fukuoka, 810-0021

  • GSK Investigational Site

    Fukuoka, 812-0025

  • GSK Investigational Site

    Fukuoka, 813-8588

  • GSK Investigational Site

    Kanagawa, 224-8503

  • GSK Investigational Site

    Tokyo, 141-0001

  • GSK Investigational Site

    Tokyo, 142-8666

  • GSK Investigational Site

    Tokyo, 154-0024

Other trials in Japan

United Kingdom7 sites

  • GSK Investigational Site

    Atherstone, Warwickshire, CV9 1EU

  • GSK Investigational Site

    Bangor, BT19 1NB

  • GSK Investigational Site

    Belfast, BT7 2EB

  • GSK Investigational Site

    Bradford on Avon, Wiltshire, BA15 1DQ

  • GSK Investigational Site

    Broughshane, BT42 4JP

  • GSK Investigational Site

    Liverpool, L22 0LG

  • GSK Investigational Site

    Newtonabbey, BT37 9QW

Other trials in United Kingdom

Brazil6 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-221

  • GSK Investigational Site

    Curitiba, Paraná, 80810-050

  • GSK Investigational Site

    Curitiba/PR, 80240-280

  • GSK Investigational Site

    São Paulo, 04023-900

  • GSK Investigational Site

    São Paulo, 04266-010

  • GSK Investigational Site

    São Paulo, 05403-000

Other trials in Brazil

Australia5 sites

  • GSK Investigational Site

    Maroubra, New South Wales, 2035

  • GSK Investigational Site

    Sherwood, Queensland, 4075

  • GSK Investigational Site

    Umina, New South Wales, 2257

  • GSK Investigational Site

    Westmead, New South Wales, 2145

  • GSK Investigational Site

    Wollongong, New South Wales, 2522

Other trials in Australia

Taiwan4 sites

  • GSK Investigational Site

    Taichung, 40447

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taoyuan County, 333

Other trials in Taiwan

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tartu, 50106

Other trials in Estonia

Hong Kong2 sites

  • GSK Investigational Site

    Kwun Tong

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

Mexico2 sites

  • GSK Investigational Site

    Durango, 34000

  • GSK Investigational Site

    Zapopan, Jalisco, Jalisco, 45190

Other trials in Mexico

Czechia1 site

  • GSK Investigational Site

    Hradec Králové

Other trials in Czechia

Finland1 site

  • GSK Investigational Site

    Tampereen Yliopisto, 33014

Other trials in Finland

About this study

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.

Read the detailed description

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.

Conditions
Herpes Zoster
Being tested
Encoding of data collected in Zoster 006 and Zoster 022 studies
Keywords
immunogenicity, Herpes Zoster, efficacy, safety, frailty, Shingles vaccine
Medical subject headings
Herpes Zoster, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Encoding of data collected in Zoster 006 and Zoster 022 studiesOther

    Not applicable (disease epidemiology study)

Study groups in NCT03563183
Study groupRoleWhat they receive
Overall GroupAdults aged ≥50 years of age in the Zoster-064 TVC who received herpes zoster subunit (HZ/su) vaccine or Placebo in Zoster-006/022 study
Receives: Other: Encoding of data collected in Zoster 006 and Zoster 022 studies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects by Frailty Status, at Baseline

    Frailty status was measured in relation to the accumulation of deficits using a Frailty Index (FI) adapted from the model proposed by Mitnitski et al. [Mitnitski, 2001]. The different aspects of frailty composing the FI were assessed through the medical history and components of the Short Form 36 Questionnaire (SF-36) and EuroQol (EQ)-5D questionnaires recorded pre-vaccination Dose 1 (in the study ZOSTER-006[NCT01165177] and ZOSTER-022[NCT01165229]).

    If the FI was less than or equal to 0.08, the subject was classified as Non-Frail. If the score was greater than 0.08 but less than or equal to 0.25, the subject was classified as pre-frail. If the score was greater than 0.25, the subject was classified as Frail. Subjects without a FI score were classified as unknown.

    Measured: At Baseline (Month 0)

Secondary outcomes (13)

  1. Distribution of Short Form 36 (SF-36) Questionnaire Scale Scores, by Country

    The mean and standard deviation of the SF-36 Questionnaire scale scores are presented for each time point. The SF-36 is a multi-purpose health survey with 36 questions underlying the construction of 8 scales [Ware, 2001]: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH).

    All but one of the 36 items (self-reported health transition) are used to score the eight SF-36 scales. Each item is used in scoring only one scale. Scale scores are constructed following the summated ratings and standardized SF-36 scoring algorithms. The SF-36 scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life.

    Measured: At Month 0, 14, 26 and 38

  2. Distribution of EuroQol (EQ)-5D Questionnaire Scale Scores, by Country

    The EQ-5D questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 possible responses (No symptoms, Moderate symptoms, Extreme symptoms). The 5 items are then combined to generate health profiles that are subsequently converted to a continuous single index utility score using a one to one matching. Country or region-specific value sets are used for the score conversion. The scores range from less than 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.

    The EQ-5D also contains a visual analogue scale (VAS). The VAS records the respondent's self-rated health on a vertical scale, ranging from 0(worst imaginable health state) to 100(best imaginable health state).

    Measured: At Month 0, 14, 26 and 38

  3. Incidence Rate (Per 1000 Person-years) of Confirmed Herpes Zoster (HZ) Cases, by Frailty Status

    Incidence rate (IR) of confirmed Herpes zoster (HZ) cases with 95% Confidence Interval (CI) calculated as the number of cases per 1000 person-years : numerator = number of confirmed HZ cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first confirmed HZ cases or occurrence of treatment for relapse. A suspected HZ case defined as (1) new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) clinical presentation and specific laboratory findings suggestive of VZV infection in the absence of HZ or VZV rash. A suspected case of HZ was confirmed either by PCR or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.

    Measured: During the entire study period (3 to 5 year period following Day 0)

  4. Herpes Zoster Burden of Illness Score, by Frailty Status

    Zoster Brief Pain Inventory (ZBPI) Burden of Illness (BOI) score was calculated as the sum of the ZBPI worst pain scores for all subjects in the group divided by the total follow-up time (Person-years). HZ Burden of Illness score for subjects was calculated from the Zoster Brief Pain Inventory (ZBPI), for each confirmed HZ cases responding to the "worst pain" question in both ZOSTER-006 and ZOSTER-022, and defined as the area under the curve of confirmed HZ-associated pain plotted against time during the 182-day period after the onset of the case. Subjects who developed HZ presented "burden-of-illness" scores ranging from 0 up to, theoretically, 1820. A score of 0 is recorded for subjects in whom HZ did not develop during the study period. Subjects who had a confirmed Zoster episode but who did not have at least 1 ZBPI assessment were excluded from the analysis.

    Measured: During the entire study period (3 to 5 year period following Day 0)

  5. Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Frailty Status

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

    Measured: Within 7 days (Days 0-6) after each vaccination

  6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Frailty Status

    Assessed solicited general symptoms were, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and gastro-intestinal (GI) symptoms(nausea, vomiting, diarrhoea and/or abdominal pain) Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

    Measured: Within 7 days (Days 0-6) after each vaccination

  7. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs), by Frailty Status

    An unsolicited AE covered 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. 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.

    Measured: Within 30 days (Days 0 - 29) after each vaccination

  8. Number of Subjects With Any and Related Serious Adverse Events (SAEs), by Frailty Status

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs were those considered vaccine-related by the investigator.

    Measured: From Month 0 to Month 14

  9. Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine, by Frailty Status

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs throughout the entire study period by frailty status were reported for SAEs considered related to study participation or to a concurrent GSK medication/vaccine.

    Measured: During the entire study period (3 to 5 year period following Day 0)

  10. Number of Subjects With Any Fatal Serious Adverse Events (SAEs), by Frailty Status

    Serious adverse events (SAEs) assessed include medical occurrences that result in death.

    Measured: During the entire study period (3 to 5 year period following Day 0)

  11. Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs), by Frailty Status

    Potential immune-mediated diseases (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 assessed by the investigator as related to the vaccination.

    Measured: During the entire study period (3 to 5 year period following Day 0)

  12. Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects

    Anti-gE Ab concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), in a subset of subjects. The assay cut-off is 97 milli-international units (mIU)/mL.

    Measured: Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38

  13. Anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects

    Anti-VZV Ab concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), in a subset of subjects. The assay cut-off is 25 mIU/mL.

    Measured: Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start5 Jun 2018
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
26,976 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563183
Sponsor's protocol ID
204878
Status last verified
Apr 2020
First submitted
4 Jun 2018
Last updated
30 Apr 2020
FDA-regulated drug
Yes

Publications

  • Curran D, Kim JH, Matthews S, Dessart C, Levin MJ, Oostvogels L, Riley ME, Schmader KE, Cunningham AL, McNeil SA, Schuind AE, Andrew MK; Zoster-064 Study Group. Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals. J Am Geriatr Soc. 2021 Mar;69(3):744-752. doi: 10.1111/jgs.16917. Epub 2020 Nov 16.

    PubMed 33197294

Questions about this trial

What is this clinical trial studying?

An observational study of Herpes Zoster, run by GlaxoSmithKline at 169 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in Germany, United States, Canada, France, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects by Frailty Status, at Baseline (time frame: At Baseline (Month 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563183, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.

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Clinical Trial NCT03563183 | AzTrials