Phase
Condition
Chickenpox (Varicella Zoster Infection)
Rash
Herpes Simplex Infections
Treatment
Placebo
Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)
Clinical Study ID
Ages > 50 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
GSK Investigational Site
Tallinn, 13619
EstoniaSite Not Available
GSK Investigational Site
Tartu, 50106
EstoniaSite Not Available
GSK Investigational Site
Helsinki, 00180
FinlandSite Not Available
GSK Investigational Site
Jyvaskyla, 40100
FinlandSite Not Available
GSK Investigational Site
Kuopio, 70100
FinlandSite Not Available
GSK Investigational Site
Tampere, FI-33100
FinlandSite Not Available
GSK Investigational Site
Turku, 20100
FinlandSite Not Available
GSK Investigational Site
Hong Kong, 000000
Hong KongSite Not Available
GSK Investigational Site
Pokfulam, 000000
Hong KongSite Not Available
GSK Investigational Site
Shatin, 000000
Hong KongSite Not Available
GSK Investigational Site
Toluca, Estado De México 50130
MexicoSite Not Available
GSK Investigational Site
Zapopan, Jalisco, Jalisco 45190
MexicoSite Not Available
GSK Investigational Site
Jojutla, Morelos 62900
MexicoSite Not Available
GSK Investigational Site
San Nicolas de los Garza, Nuevo León 66480
MexicoSite Not Available
GSK Investigational Site
Merida, Yucatán 97070
MexicoSite Not Available
GSK Investigational Site
Mérida, Yucatán 97000
MexicoSite Not Available
GSK Investigational Site
Durango, 34000
MexicoSite Not Available
GSK Investigational Site
Guadalajara, 44638
MexicoSite Not Available
GSK Investigational Site
Mexico City, 06760
MexicoSite Not Available
GSK Investigational Site
Oaxaca, 68000
MexicoSite Not Available
GSK Investigational Site
Panama, 1001
PanamaSite Not Available
GSK Investigational Site
Panama City,
PanamaSite Not Available
GSK Investigational Site
Barnaul, 656043
Russian FederationSite Not Available
GSK Investigational Site
Ekaterinburg, 620137
Russian FederationSite Not Available
GSK Investigational Site
Gatchina, 188300
Russian FederationSite Not Available
GSK Investigational Site
Moscow, 115478
Russian FederationSite Not Available
GSK Investigational Site
Saint Petersburg, 197022
Russian FederationSite Not Available
GSK Investigational Site
Saint-Petersburg, 197022
Russian FederationSite Not Available
GSK Investigational Site
St.Petersburg, 197089
Russian FederationSite Not Available
GSK Investigational Site
Tomsk, 634 05
Russian FederationSite Not Available
GSK Investigational Site
Avila, 05071
SpainSite Not Available
GSK Investigational Site
Barcelona, 08035
SpainSite Not Available
GSK Investigational Site
Centelles (Barcelona), 08540
SpainSite Not Available
GSK Investigational Site
Hospitalet de Llobregat, 08907
SpainSite Not Available
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430
SpainSite Not Available
GSK Investigational Site
Madrid, 28222
SpainSite Not Available
GSK Investigational Site
Majadahonda( Madrid, 28222
SpainSite Not Available
GSK Investigational Site
Palma de Mallorca, 07010
SpainSite Not Available
GSK Investigational Site
Pama de Mallorca, 07010
SpainSite Not Available
GSK Investigational Site
Valencia, 46020
SpainSite Not Available
GSK Investigational Site
Vic/ Barcelona, 08500
SpainSite Not Available
GSK Investigational Site
Upton, Poole, Dorset BH16 5
United KingdomSite Not Available
GSK Investigational Site
Addlestone, Surrey KT15 2BH
United KingdomSite Not Available
GSK Investigational Site
Atherstone, Warwickshire CV9 1EU
United KingdomSite Not Available
GSK Investigational Site
AddlestoneSurrey, KT15 2BH
United KingdomSite Not Available
GSK Investigational Site
Atherstone Warwickshire, CV9 1EU
United KingdomSite Not Available
GSK Investigational Site
Belfast, BT7 2EB
United KingdomSite Not Available
GSK Investigational Site
Bexhill-on-Sea, TN40 1
United KingdomSite Not Available
GSK Investigational Site
Bradford on Avon, BA15 1DQ
United KingdomSite Not Available
GSK Investigational Site
Clevedon, BS21 6
United KingdomSite Not Available
GSK Investigational Site
Manchester, M14 6WP
United KingdomSite Not Available
GSK Investigational Site
Nantwich Cheshire, CW5 5NX
United KingdomSite Not Available
GSK Investigational Site
Nantwich, Cheshire, CW5 5NX
United KingdomSite Not Available
GSK Investigational Site
Poole, BH16 5PW
United KingdomSite Not Available
GSK Investigational Site
Trowbridge, BA14 8QA
United KingdomSite Not Available
GSK Investigational Site
Oakland, California 94612
United StatesSite Not Available
GSK Investigational Site
Wichita, Kansas 67207
United StatesSite Not Available
GSK Investigational Site
Milford, Massachusetts 01757
United StatesSite Not Available
GSK Investigational Site
Erie, Pennsylvania 16508
United StatesSite Not Available
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