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Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Herpes Zoster Vaccine

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Trial Information

Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies


Inclusion Criteria:



- 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.

- Subject who has been diagnosed with one or more haematologic malignancies prior to
the first vaccination and who is receiving, is scheduled to receive or has just
finished immunosuppressive cancer therapy to treat this condition.

- Life expectancy greater than or equal to 12 months, as assessed by the investigator.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Non-childbearing potential is defined as pre-menarche, current tubal ligation,
hysterectomy, ovariectomy or post-menopause.

- Female subjects of childbearing potential may be enrolled inthe study, if the
subject:

- 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 during the entire treatment period
and for 2 months after completion of the vaccination series.

Exclusion Criteria:

- Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral
cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous
cancer therapy in combination with oral therapy may be enrolled).

- Subject receiving radiotherapy alone as treatment for his/her haematologic
malignancy.

- Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT
occurred prior to enrolment in the study, the subject may not receive study vaccine
until at least 50 days after the transplant procedure).

- Human immunodeficiency virus (HIV) infection by clinical history.

- 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 product to
treat the subject's 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 or varicella vaccine (including an
investigational or non-registered 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 any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine.

- Administration or planned administration of a live vaccine in the period starting 30
days before the first dose of study vaccine and ending 30 days after the last dose of
study vaccine.

- Administration or planned administration of a non-replicating vaccine within 8 days
prior to or within 14 days after either dose of study vaccine.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions before Month 3 (i.e., 2 months after the last dose of study
vaccine/placebo).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Occurrence of solicited local and general symptoms

Outcome Time Frame:

Up to 7 days (Days 0-6) after each vaccination

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

New Zealand: Medsafe

Study ID:

116428

NCT ID:

NCT01767467

Start Date:

March 2013

Completion Date:

May 2015

Related Keywords:

  • Herpes Zoster Vaccine
  • Immunogenicity
  • Safety
  • Herpes zoster
  • Vaccination
  • Haematologic malignancies
  • Herpes Zoster
  • Hematologic Neoplasms

Name

Location

GSK Investigational SiteGainesville, Florida  32610