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

This study is currently recruiting participants.
Verified April 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01610414
First received: May 31, 2012
Last updated: April 10, 2014
Last verified: April 2014
  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
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:


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: November 2016
Estimated Primary Completion Date: October 2014 (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 165 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: April 10, 2014
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 April 17, 2014