Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A - Full Text View

Purpose

The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.

Condition	Intervention	Phase
Herpes Zoster (HZ)	Biological: Herpes Zoster vaccine GSK1437173A Biological: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Herpes Zoster Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of confirmed HZ cases [ Time Frame: From Month 0 until study end (4 years approximately) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of 'worst' HZ-associated pain [ Time Frame: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period ] [ Designated as safety issue: No ]
Occurrence of confirmed HZ-associated complications [ Time Frame: From Month 0 up until study end (4 years approximately) ] [ Designated as safety issue: No ]
Occurrence of Postherpetic Neuralgia (PHN) [ Time Frame: From Month 0 until study end (4 years approximately) ] [ Designated as safety issue: No ]
Antigen-specific Antibody (Ab) concentrations in a sub-cohort of subjects [ Time Frame: At Month 0, Month 1, Month 2, Month 13 and Month 25 ] [ Designated as safety issue: No ]
Occurrence of solicited local and general symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
Occurrence of unsolicited adverse events (AEs) [ Time Frame: During 30 days (Days 0-29) after each vaccination ] [ Designated as safety issue: No ]
Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (4 years approximately) ] [ Designated as safety issue: No ]
Occurrence of AEs of specific interest [ Time Frame: From Month 0 until study end (4 years, approximately) ] [ Designated as safety issue: No ]

Estimated Enrollment:	1474
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vaccine Group Subjects will receive the candidate HZ vaccine GSK 1437173A	Biological: Herpes Zoster vaccine GSK1437173A 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm
Placebo Comparator: Placebo Group Subjects will receive the placebo	Biological: Placebo 2 doses administered IM in deltoid region of non-dominant arm

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Study entry (enrollment) occurs at the Pre-vaccination visit.

Subjects who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
A male or female aged 18 years or older at the time of study entry.
Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs.
Female subjects of non-childbearing potential may be enrolled in the study. For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, 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 12 months after completion of the vaccination series (i.e., until Month 13).

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered or non-registered product to treat the subject's underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed.
Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
Planned administration during the study of a HZ vaccine other than the study vaccine.
Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV) expected to last more than 6 months after transplantation.
Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo.
HIV infection by clinical history.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610414

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Show 105 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01610414 History of Changes
Other Study ID Numbers:	115523, 2012-000138-20
Study First Received:	May 31, 2012
Last Updated:	May 9, 2013
Health Authority:	New Zealand: Medsafe United States: Food and Drug Administration Spain: Agencia Española del Medicamento y Productos Sanitarios Hong Kong: Department of Health, The Government of the Hong Kong Special Administrative Region Turkey: General Directorate of Pharmacy and Pharmaceuticals Panama: National Committee of Bioethics in Health Research of the Gorgas Memorial Institute for Health Studies Italy: Agenzia Italiana del Farmaco Finland: Finnish Medicines Agency France: Agence Nationale de Sécurité du Médicament et des produits de santé Poland: URZAD REJESTRACJI PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH Taiwan: Taiwan Food and Drug Administration (TFDA) Malaysia: Drug Control Authority (DCA) Canada: Health Canada - Biologics and Genetic Therapies Directorate Japan: Pharmaceutical and Medical Device Agency US: Center for Biologics Evaluation and Research (CBER) United Kingdom: Medicines and Healthcare Products Regulatory Agency South Africa: Medicines Control Council Korea: Korea Food & Drug Administration India: Central Drugs Standard Control Organization Belgium: Agence Federale des Medicaments et des produits de sante Germany: Paul-Ehrlich-Institut Brazil: Agência Nacional de Vigilância Sanitária (ANVISA) Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

Observer-blind
Efficacy
Immunogenicity
Vaccination

Safety
Adult autologous haematopoietic cell transplant recipients
Herpes Zoster

Additional relevant MeSH terms:

Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013