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AzTrials

Herpes ZosterPhase 3NCT01165229

Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

A Phase 3 study testing Herpes Zoster Vaccine GSK1437173A in people with Herpes Zoster and Herpes Zoster Vaccine, run by GlaxoSmithKline at 213 sites in 18 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Herpes Zoster, Herpes Zoster Vaccine
What is being tested?
Herpes Zoster Vaccine GSK1437173A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14,819 participants
Where
213 sitesin 18 countries
Study dates
2 Aug 2010to 24 Jul 2015
Phase
Phase 3
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 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Subjects who the investigator believes will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • A male or female aged 70 years or older at the time of the first vaccination.

Who cannot join

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy History of HZ.
  • Previous vaccination against varicella or HZ.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
Show all 11Show fewer
  • Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period.
  • Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
  • Acute disease and/or fever at the time of enrolment.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

Trial locations and contacts

213 sites in 18 countries.

213 sites in 18 countries

United States43 sites

  • GSK Investigational Site

    Arlington, Virginia, 22203

  • GSK Investigational Site

    Baltimore, Maryland, 21209

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Carnegie, Pennsylvania, 15106

  • GSK Investigational Site

    Cary, North Carolina, 27518

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Clearwater, Florida, 33761

  • GSK Investigational Site

    Cleveland, Ohio, 44122

  • GSK Investigational Site

    Columbia, Maryland, 21045

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Edison, New Jersey, 08817

  • GSK Investigational Site

    Greer, South Carolina, 29650

  • GSK Investigational Site

    Hickory, North Carolina, 28602

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Las Vegas, Nevada, 89104

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Meridian, Idaho, 83642

  • GSK Investigational Site

    Mesa, Arizona, 85213

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Murray, Utah, 84123

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Overland Park, Kansas, 66212

  • GSK Investigational Site

    Phoenix, Arizona, 85018

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Phoenix, Arizona, 85050

  • 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

    Somers Point, New Jersey, 08244

  • GSK Investigational Site

    Spring Valley, California, 91978

  • GSK Investigational Site

    Tucson, Arizona, 85704

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    Vista, California, 92083

  • 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

Germany39 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, 12351

  • 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

    Köthen, Saxony-Anhalt, 06366

  • GSK Investigational Site

    Künzing, Bavaria, 94550

  • GSK Investigational Site

    Leipzig, Saxony, 04315

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23554

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • 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

    Potsdam, Brandenburg, 14467

  • 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

Canada15 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

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3P9

  • GSK Investigational Site

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

France14 sites

  • GSK Investigational Site

    Angers, 49000

  • 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

    Laval, 53100

  • GSK Investigational Site

    Montrevault, 49110

  • GSK Investigational Site

    Muret, 31600

  • GSK Investigational Site

    Nantes, 44300

  • GSK Investigational Site

    Rosiers-d'Égletons, 19300

  • GSK Investigational Site

    Saint Cyr Sur Loir, 37540

  • GSK Investigational Site

    Segré, 49500

  • GSK Investigational Site

    Soulaines-sur-Aubance, 49610

  • 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

  • GSK Investigational Site

    La Roca Del Valles (Barcelona), 08430

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Majadahonda

  • GSK Investigational Site

    Peralada( Girona), 17491

  • GSK Investigational Site

    Valencia, 46020

  • GSK Investigational Site

    Vic/ Barcelona, 08500

Other trials in Spain

Sweden12 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-58758

  • GSK Investigational Site

    Malmö, SE-211 52

  • GSK Investigational Site

    Örebro, SE-703 62

  • GSK Investigational Site

    Skövde, SE-541 85

  • GSK Investigational Site

    Stockholm, SE-111 57

  • GSK Investigational Site

    Uppsala, SE-751 85

  • GSK Investigational Site

    Vällingby, SE-162 68

Other trials in Sweden

Finland10 sites

  • GSK Investigational Site

    Espoo, 02230

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Helsinki, 00930

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Kokkola, 67100

  • GSK Investigational Site

    Oulu, 90220

  • GSK Investigational Site

    Pori, 28100

  • GSK Investigational Site

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33100

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Italy10 sites

  • GSK Investigational Site

    Cagliari, Sardinia, 09127

  • GSK Investigational Site

    Catania, Sicily, 95129

  • GSK Investigational Site

    Chieti, Abruzzo, 66013

  • GSK Investigational Site

    Cuneo, Piedmont, 12100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Monza, Lombardy, 20052

  • GSK Investigational Site

    Pescara, Abruzzo, 65100

  • GSK Investigational Site

    Ragusa (RG), Sicily, 97100

  • GSK Investigational Site

    Rome, Lazio, 00163

  • GSK Investigational Site

    Sassari, Sardinia, 07100

Other trials in Italy

Japan10 sites

  • GSK Investigational Site

    Fukuoka, 810-0021

  • GSK Investigational Site

    Fukuoka, 812-0025

  • GSK Investigational Site

    Fukuoka, 813-8588

  • GSK Investigational Site

    Fukuoka, 816-0864

  • GSK Investigational Site

    Kanagawa, 224-8503

  • GSK Investigational Site

    Kanagawa, 247-8533

  • GSK Investigational Site

    Kyoto, 611-0041

  • GSK Investigational Site

    Tokyo, 141-0001

  • GSK Investigational Site

    Tokyo, 142-8666

  • GSK Investigational Site

    Tokyo, 154-0024

Other trials in Japan

Australia9 sites

  • GSK Investigational Site

    Caboolture, Queensland, 4510

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Glebe, New South Wales, 2037

  • GSK Investigational Site

    Ivanhoe, Victoria, 3079

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Maroubra, New South Wales, 2035

  • 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

United Kingdom9 sites

  • GSK Investigational Site

    Atherstone, Warwickshire, CV9 1EU

  • GSK Investigational Site

    Bangor, BT19 1PP

  • GSK Investigational Site

    Belfast, BT7 2EB

  • GSK Investigational Site

    Bradford on Avon, Wiltshire, BA15 1DQ

  • GSK Investigational Site

    Broughshane, BT42 4JP

  • GSK Investigational Site

    Buckshaw Village, Chorley, Lancashire, PR7 7NA

  • GSK Investigational Site

    Ledbury, HR8 2AA

  • GSK Investigational Site

    Newtonabbey, BT37 9QW

  • GSK Investigational Site

    Waterloo, Liverpool, L22 0LG

Other trials in United Kingdom

South Korea8 sites

  • GSK Investigational Site

    Ansan, 425-707

  • GSK Investigational Site

    Bucheon-si, 420-767

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Kangnam-gu, Seoul

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 150-950

  • GSK Investigational Site

    Seoul, 152-703

Other trials in South Korea

Brazil7 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-221

  • GSK Investigational Site

    Curitiba/Paraná, Paraná, 80810-050

  • GSK Investigational Site

    Curitiba/PR, 80240-280

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035003

  • GSK Investigational Site

    São Paulo, 04038 002

  • GSK Investigational Site

    São Paulo, 04266-010

  • GSK Investigational Site

    São Paulo, 04312903

Other trials in Brazil

Mexico4 sites

  • GSK Investigational Site

    Cuernavaca, Morelos, 62210

  • GSK Investigational Site

    Durango, 34000

  • GSK Investigational Site

    Monterrey

  • GSK Investigational Site

    Zapopan, Jalisco, Jalisco, 45190

Other trials in Mexico

Taiwan4 sites

  • GSK Investigational Site

    Taichung, 40447

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taipei

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Czechia3 sites

  • GSK Investigational Site

    Brno, 662 10

  • GSK Investigational Site

    České Budějovice, 370 04

  • GSK Investigational Site

    Hradec Králové, 500 01

Other trials in Czechia

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

About this study

Official title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years.

Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.

Read the detailed description

This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.

Being tested
Herpes Zoster Vaccine GSK1437173A, Placebo
Keywords
Immunogenicity, Subjects 70 years and older, Efficacy, Herpes Zoster, Safety, Adults, Vaccine
Medical subject headings
Herpes Zoster

What participants receive

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

  • Herpes Zoster Vaccine GSK1437173ABiological

    Intramuscular injection

  • PlaceboBiological

    Intramuscular injection.

Study groups in NCT01165229
Study groupRoleWhat they receive
Zoster vaccine groupExperimentalSubjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule
Receives: Biological: Herpes Zoster Vaccine GSK1437173A
Placebo groupPlacebo comparatorSubjects will receive NaCl solution placebo according to a 0, 2-month schedule
Receives: Biological: Placebo

What is being measured

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

  1. Number of Subjects With Any Episodes of Herpes Zoster (HZ)

    Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).

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

  2. Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)

    Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).

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

  3. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ

    Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.

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

Secondary outcomes (27)

  1. Number of Subjects With Post-herpetic Neuralgia (PHN)

    PHN cases in the mTVc.

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

  2. Number of Days With Severe 'Worst' HZ-associated Pain

    Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.

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

  3. Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations

    The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.

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

  4. Number of Subjects With Overall Mortality and HZ-related Mortality

    The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.

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

  5. Number of Subjects With Confirmed HZ Episode Related Hospitalizations

    Incidence of overall and HZ-related hospitalizations during the study.

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

  6. Number of Subjects With HZ Related Complications

    Incidence of HZ complications during the study in subjects with confirmed HZ.

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

  7. Number of Subjects Receiving Pain Medication Associated With HZ

    Incidence of use of pain medications throughout the study

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

  8. Number of Days With Pain Medication Associated With HZ

    Incidence of reduction of duration of pain medication associated with HZ throughout the study.

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

  9. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

    Measured: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  10. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. 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 the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  11. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. 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 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 the 30 days (Days 0-29) after each vaccination

  12. Number of Subjects With Any and Related Serious Adverse Events (SAEs)

    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.

    Measured: From Month 0 to Month 14

  13. Number of Subjects With Fatal Serious Adverse Events (SAEs)

    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.

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

  14. Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication

    The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated

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

  15. Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)

    Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects

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

  16. Number of Subjects With Any and Related Medically Attended Visits

    Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.

    Measured: From Month 0 to Month 8 post-vaccination

  17. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA

    Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.

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

  18. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ

    Occurrence of PHN during the entire study period in all subjects with confirmed HZ.

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

  19. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.

    The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ .

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

  20. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.

    Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.

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

  21. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. 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 the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  22. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

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

    Measured: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  23. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA

    Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.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 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

  24. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs

    Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.

    Measured: From Month 0 to Month 14

  25. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs

    Fatal SAEs during the entire study period in subjects ≥ 70 YOA.

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

  26. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs

    Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.

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

  27. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits

    Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA.

    Measured: From Month 0 to Month 8 post-vaccination

Timeline

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

  1. First posted19 Jul 2010 (estimated)
  2. Study start2 Aug 2010
  3. Primary completion24 Jul 2015
  4. Study completion24 Jul 2015

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
14,819 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01165229
Sponsor's protocol ID
113077
Other IDs
2009-015791-94, 2009
Status last verified
Apr 2020
First submitted
15 Jul 2010
Last updated
27 Apr 2020
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC; ZOE-70 Study Group. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.

    PubMed 27626517

  • Cunningham AL, Heineman TC, Lal H, Godeaux O, Chlibek R, Hwang SJ, McElhaney JE, Vesikari T, Andrews C, Choi WS, Esen M, Ikematsu H, Choma MK, Pauksens K, Ravault S, Salaun B, Schwarz TF, Smetana J, Abeele CV, Van den Steen P, Vastiau I, Weckx LY, Levin MJ; ZOE-50/70 Study Group. Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.

    PubMed 29529222

  • Ikematsu H et al. (2018) Efficacy, safety and immunogenicity of new adjuvanted herpes zoster subunit vaccine for Japanese over 50 years old and over 70 years old. Kansenshogaku Zasshi. 92(2):103-114.

  • Kovac M, Lal H, Cunningham AL, Levin MJ, Johnson RW, Campora L, Volpi A, Heineman TC; ZOE-50/70 Study Group. Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018 Mar 14;36(12):1537-1541. doi: 10.1016/j.vaccine.2018.02.029. Epub 2018 Feb 17.

    PubMed 29463421

  • Matthews S, Curran D, Sabater Cabrera E, Boutry C, Lecrenier N, Cunningham AL, Schmader K. An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies. Clin J Pain. 2023 Aug 1;39(8):386-393. doi: 10.1097/AJP.0000000000001129.

    PubMed 37166199

  • Kim JH, Johnson R, Kovac M, Cunningham AL, Amakrane M, Sullivan KM, Dagnew AF, Curran D, Schuind A. Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials. Pain. 2023 Apr 1;164(4):741-748. doi: 10.1097/j.pain.0000000000002760. Epub 2022 Aug 19.

    PubMed 36066965

  • Kim JH, Diaz-Decaro J, Jiang N, Hwang SJ, Choo EJ, Co M, Hastie A, Hui DSC, Irimajiri J, Lee J, Leung EM, Tang H, Tsuru T, Watson P, Wu Z, Yu CJ, Yuan Y, Zahaf T, Cunningham AL, Schuind A. The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults >/= 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials. Hum Vaccin Immunother. 2021 Jul 3;17(7):2050-2057. doi: 10.1080/21645515.2020.1859321. Epub 2021 Feb 19.

    PubMed 33606577

  • Dagnew AF, Rausch D, Herve C, Zahaf T, Levin MJ, Schuind A; ZOE-50/70 study group. Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials. Rheumatology (Oxford). 2021 Mar 2;60(3):1226-1233. doi: 10.1093/rheumatology/keaa424.

    PubMed 32910152

  • Colindres R, Wascotte V, Brecx A, Clarke C, Herve C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, Cunningham AL. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29.

    PubMed 32347767

  • Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, Schuind A; ZOE 50/70 study groups. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16.

    PubMed 31537443

  • Lopez-Fauqued M, Campora L, Delannois F, El Idrissi M, Oostvogels L, De Looze FJ, Diez-Domingo J, Heineman TC, Lal H, McElhaney JE, McNeil SA, Yeo W, Tavares-Da-Silva F; ZOE-50/70 Study Group. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. Vaccine. 2019 Apr 24;37(18):2482-2493. doi: 10.1016/j.vaccine.2019.03.043. Epub 2019 Mar 29.

    PubMed 30935742

  • Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, Berglund J, Campora L, de Looze F, Korhonen T, Leung E, Levin M, Volpi A, Johnson RW; ZOE-50/70 Study Group. Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238. doi: 10.1093/gerona/gly150.

    PubMed 29955836

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Herpes Zoster Vaccine GSK1437173A in people with Herpes Zoster and Herpes Zoster Vaccine, run by GlaxoSmithKline at 213 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 3 inclusion and 11 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 27 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 213 sites in United States, Germany, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2017). 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 With Any Episodes of Herpes Zoster (HZ) (time frame: During the entire study period (3 to 5 year period following Day 0)). The study lists 3 primary outcomes in all. 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 NCT01165229, which also lists 12 linked publications.

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 27 Apr 2020.

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