Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster

Last updated: March 27, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Chickenpox (Varicella Zoster Infection)

Rash

Herpes Simplex Infections

Treatment

Placebo

Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)

Clinical Study ID

NCT04091451
204939
2016-000744-34
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can andwill comply with the requirements of the protocol

  • Written informed consent obtained from the subject/subject's LAR(s) prior toperformance of any study specific procedure.

  • A male or female ≥ 50 YOA at the time of the first vaccination.

  • Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done byone of the following three methods:

  • Clinically diagnosed HZ:

OR Laboratory diagnosed HZ: OR

  • HZ diagnosed by an adjudication committee: Female subjects of non-childbearingpotential may be enrolled in the study.

  • Non-childbearing potential is defined as current bilateral tubal ligation orocclusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy orpost-menopause.

• Female subjects of childbearing potential may be enrolled in the study if thesubject:

  • 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 for 2 months after completion of thevaccination series.

Exclusion

Exclusion Criteria:

  • Subjects who at time of study entry or during the maximum period of anticipatedstudy participation are/will become part of the population recommended to receive azoster vaccine per existing local or national immunization practices will beexcluded from study participation.

  • Use of any investigational or non-registered product other than the study vaccineduring the period starting 30 days before the first dose of study vaccine, orplanned use during the study period.

  • Any medical condition that in the judgment of the investigator would makeintramuscular injection unsafe.

  • Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.

  • Chronic antiviral use for HZ prophylaxis.

  • History of >1 prior episode of HZ.

  • A history of disseminated HZ, cutaneous or associated with visceral disease orassociated with neurologic disease caused by VZV infection.

  • Use or anticipated use of immunosuppressants or immune-modifying drugs during theperiod starting six months prior to study start and during the whole study period.This includes chronic administration of corticosteroids, long-actingimmune-modifying agents or immunosuppressive/cytotoxic therapy

  • Administration or planned administration of a vaccine not foreseen by the studyprotocol within the period starting 30 days before the first dose of study vaccineand ending 30 days after the last dose of study vaccine. However, licensedpneumococcal vaccines and non-replicating vaccines may be administered up until 8days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of studyvaccine.

  • Concurrently participating in another clinical study, at any time during the studyperiod, in which the subject has been or will be exposed to an investigational or anon-investigational vaccine/product

  • Previous vaccination against VZV or HZ.

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical history and physical examination

  • History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the vaccine.

  • Acute disease and/or fever at the time of enrolment.

  • Administration of immunoglobulins and/or any blood products during the periodstarting 3 months before the first dose of study vaccine or planned administrationduring the study period.

  • Pregnant or lactating female.

  • Female planning to become pregnant or planning to discontinue contraceptiveprecautions in the period up to 2 months after completion of the vaccination series.

Study Design

Total Participants: 1430
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 17, 2019
Estimated Completion Date:
February 15, 2024

Connect with a study center

  • GSK Investigational Site

    Tallinn, 13619
    Estonia

    Site Not Available

  • GSK Investigational Site

    Tartu, 50106
    Estonia

    Site Not Available

  • GSK Investigational Site

    Helsinki, 00180
    Finland

    Site Not Available

  • GSK Investigational Site

    Jyvaskyla, 40100
    Finland

    Site Not Available

  • GSK Investigational Site

    Kuopio, 70100
    Finland

    Site Not Available

  • GSK Investigational Site

    Tampere, FI-33100
    Finland

    Site Not Available

  • GSK Investigational Site

    Turku, 20100
    Finland

    Site Not Available

  • GSK Investigational Site

    Hong Kong, 000000
    Hong Kong

    Site Not Available

  • GSK Investigational Site

    Pokfulam, 000000
    Hong Kong

    Site Not Available

  • GSK Investigational Site

    Shatin, 000000
    Hong Kong

    Site Not Available

  • GSK Investigational Site

    Toluca, Estado De México 50130
    Mexico

    Site Not Available

  • GSK Investigational Site

    Zapopan, Jalisco, Jalisco 45190
    Mexico

    Site Not Available

  • GSK Investigational Site

    Jojutla, Morelos 62900
    Mexico

    Site Not Available

  • GSK Investigational Site

    San Nicolas de los Garza, Nuevo León 66480
    Mexico

    Site Not Available

  • GSK Investigational Site

    Merida, Yucatán 97070
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mérida, Yucatán 97000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Durango, 34000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Guadalajara, 44638
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mexico City, 06760
    Mexico

    Site Not Available

  • GSK Investigational Site

    Oaxaca, 68000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Panama, 1001
    Panama

    Site Not Available

  • GSK Investigational Site

    Panama City,
    Panama

    Site Not Available

  • GSK Investigational Site

    Barnaul, 656043
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Ekaterinburg, 620137
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Gatchina, 188300
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Moscow, 115478
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Saint Petersburg, 197022
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Saint-Petersburg, 197022
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St.Petersburg, 197089
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Tomsk, 634 05
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Avila, 05071
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08035
    Spain

    Site Not Available

  • GSK Investigational Site

    Centelles (Barcelona), 08540
    Spain

    Site Not Available

  • GSK Investigational Site

    Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • GSK Investigational Site

    La Roca Del Valles (Barcelona), 08430
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Majadahonda( Madrid, 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Palma de Mallorca, 07010
    Spain

    Site Not Available

  • GSK Investigational Site

    Pama de Mallorca, 07010
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46020
    Spain

    Site Not Available

  • GSK Investigational Site

    Vic/ Barcelona, 08500
    Spain

    Site Not Available

  • GSK Investigational Site

    Upton, Poole, Dorset BH16 5
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Addlestone, Surrey KT15 2BH
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Atherstone, Warwickshire CV9 1EU
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    AddlestoneSurrey, KT15 2BH
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Atherstone Warwickshire, CV9 1EU
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Belfast, BT7 2EB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Bexhill-on-Sea, TN40 1
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Bradford on Avon, BA15 1DQ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Clevedon, BS21 6
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Manchester, M14 6WP
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Nantwich Cheshire, CW5 5NX
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Nantwich, Cheshire, CW5 5NX
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Poole, BH16 5PW
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Trowbridge, BA14 8QA
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Oakland, California 94612
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • GSK Investigational Site

    Milford, Massachusetts 01757
    United States

    Site Not Available

  • GSK Investigational Site

    Erie, Pennsylvania 16508
    United States

    Site Not Available

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