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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01610414
First received: May 31, 2012
Last updated: September 25, 2014
Last verified: September 2014

May 31, 2012
September 25, 2014
July 2012
June 2015   (final data collection date for primary outcome measure)
Occurrence of confirmed HZ cases [ Time Frame: From Month 0 until study end (4 years approximately) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01610414 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Herpes Zoster
  • Biological: Herpes Zoster vaccine GSK1437173A
    2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm
  • Biological: Placebo
    2 doses administered IM in deltoid region of non-dominant arm
  • Experimental: Vaccine Group
    Subjects will receive the candidate HZ vaccine GSK 1437173A
    Intervention: Biological: Herpes Zoster vaccine GSK1437173A
  • Placebo Comparator: Placebo Group
    Subjects will receive the placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2126
November 2016
June 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United States,   Australia,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   New Zealand,   Panama,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom
 
NCT01610414
115523, 2012-000138-20
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP