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Herpes ZosterPhase 3NCT02690207

Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.

A Phase 3 study testing Herpes Zoster Vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 195 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 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… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Herpes Zoster
What is being tested?
Herpes Zoster Vaccine GSK1437173A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,687 participants
Where
195 sitesin 18 countries
Study dates
16 Mar 2016to 15 Mar 2019
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, follow-up contacts). Or subjects' Legally Acceptable Representative(s) [LAR(s)]/caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, availability for follow-up contacts).
  • Written informed consent obtained from the subject/Legally Acceptable representative(s) [LAR(s)] of the subject prior to performing any study specific procedure. If the subjects is not capable of giving consent, his/her assent to participate should be obtained to the extent possible.
  • Subject who previously participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of placebo.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
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  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination and
  • has agreed to continue adequate contraception during the entire treatment period* and for 2 months after completion of the vaccination series.
  • treatment period refers to vaccination days and the interval between them.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use up to 30 days post Dose 2.
  • Previous vaccination against Varicella Zoster virus (VZV) or HZ.
  • Planned administration of VZV or HZ vaccination during the study (including an investigational or non-registered vaccine), with the exception of the study vaccine.
  • Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant for seasonal or pandemic flus). These may be administered up to 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose and up to 30 days post Dose 2. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab) within six months prior to the first vaccine dose up to 30 days post Dose 2.
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  • Concurrently participating in another clinical study, at the time of enrolment or planned participation up to the 30 days post second dose, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, Human Immunodeficiency Virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Active HZ infection at the time of enrolment (i.e. HZ lesions not completely crusted over).
  • Pregnant or lactating female.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  • Any condition which in the judgment of the investigator would make intramuscular injection unsafe.

Trial locations and contacts

195 sites in 18 countries.

195 sites in 18 countries

United States37 sites

  • 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

    Cleveland, Ohio, 44122

  • GSK Investigational Site

    Columbia, Maryland, 21045

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Elkridge, Maryland, 21075

  • 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

    Las Vegas, Nevada, 89104

  • 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

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Phoenix, Arizona, 85018

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Phoenix, Arizona, 85050

  • GSK Investigational Site

    Pittsburgh, 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, 85712

  • 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

Germany34 sites

  • GSK Investigational Site

    Berlin, 10629

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • 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

    Freiberg, Saxony, 09599

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Güglingen, Baden-Wurttemberg, 74363

  • GSK Investigational Site

    Hamburg, 20246

  • 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, 39120

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • 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 3M9

  • GSK Investigational Site

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

France13 sites

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Angers, 49100

  • GSK Investigational Site

    Château-Gontier, 53200

  • 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, 44300

  • 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, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Majadahonda( Madrid, 28222

  • GSK Investigational Site

    Peralada( Girona), 17491

  • GSK Investigational Site

    Valencia, 46020

  • GSK Investigational Site

    Vic, 28500

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-581 85

  • GSK Investigational Site

    Malmö, SE-211 52

  • GSK Investigational Site

    Örebro, SE-703 62

  • GSK Investigational Site

    Skövde, SE-541 50

  • GSK Investigational Site

    Stockholm, 11446

  • 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

Japan9 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

    Tokyo, 142-0054

  • GSK Investigational Site

    Tokyo, 142-8666

  • GSK Investigational Site

    Tokyo, 154-0024

Other trials in Japan

Italy8 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

    Ragusa (RG), Sicily, 97100

  • GSK Investigational Site

    Rome, Lazio, 00163

  • GSK Investigational Site

    Sassari, Sardinia, 07100

Other trials in Italy

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

United Kingdom8 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

    Buckshaw Village, Chorley, Lancashire, PR7 7NA

  • GSK Investigational Site

    Liverpool, L22 0LG

  • GSK Investigational Site

    Newtonabbey, BT37 9QW

Other trials in United Kingdom

Australia7 sites

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • 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

Brazil7 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

    Porto Alegre, Rio Grande do Sul, 90035003

  • 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

Mexico4 sites

  • GSK Investigational Site

    Durango, 34000

  • GSK Investigational Site

    Jojutla, Morelos, 62900

  • GSK Investigational Site

    Monterrey, Nuevo León, 64710

  • 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

Other trials in Czechia

Estonia2 sites

  • GSK Investigational Site

    Tallinn

  • 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: Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies

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).

Read the detailed description

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.

Conditions
Herpes Zoster
Being tested
Herpes Zoster Vaccine GSK1437173A
Keywords
Herpes Zoster, Safety, Adults, Cross-vaccination
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

    Also called HZ/su

    Intramuscular injection

Study groups in NCT02690207
Study groupRoleWhat they receive
HZ/su GroupExperimentalSubjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm
Receives: Biological: Herpes Zoster Vaccine GSK1437173A

What is being measured

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

  1. 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.

    Measured: During 30 days (Days 0-29) after any vaccination (across doses)

  2. 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.

    Measured: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

  3. 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.

    Measured: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Secondary outcomes (1)

  1. 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.

    Measured: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Timeline

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

  1. First posted24 Feb 2016 (estimated)
  2. Study start16 Mar 2016
  3. Primary completion15 Mar 2019
  4. Study completion15 Mar 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8,687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02690207
Sponsor's protocol ID
204486
Other IDs
2015-000965-30, 2015
Status last verified
Feb 2021
First submitted
16 Feb 2016
Last updated
4 Mar 2021
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site.

Publications

  • Ocran-Appiah J, Boutry C, Herve C, Soni J, Schuind A; ZOSTER-056 Study Group. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients. Vaccine. 2021 Jan 3;39(1):6-10. doi: 10.1016/j.vaccine.2020.10.029. Epub 2020 Dec 1.

    PubMed 33277059

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Herpes Zoster Vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 195 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 10 inclusion and 13 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 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. 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 12 Mar 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 With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (time frame: During 30 days (Days 0-29) after any vaccination (across doses)). 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 NCT02690207, 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 4 Mar 2021.

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