Status:
COMPLETED
Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Zoster
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or ...
Detailed Description
The Protocol Posting has been updated following Protocol amendment 2, Sep 2009. The sections impacted are: eligibility criteria.
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
- Male and female subjects at least 18 years old at the time of vaccination;
- Serological evidence of prior VZV infection for all subjects born in 1980 or later and for subjects born outside the US before 1980 in a tropical or sub-tropical region. No testing for serological evidence of prior VZV infection is required for US subjects born before 1980;
- Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and there are no plans for additional HCTs
- Written informed consent obtained from the subject;
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion
- Use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;
- Administration of immunoglobulins since transplantation;
- Previous vaccination against varicella or HZ;
- History of HZ within the previous 12 months;
- Known exposure to VZV since transplantation;
- Evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° C or any serious HCT-related complication;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- Hypersensitivity or intolerance to acyclovir or valacyclovir;
- Pregnant or lactating female.
Key Trial Info
Start Date :
July 14 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2012
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00920218
Start Date
July 14 2009
End Date
March 21 2012
Last Update
December 12 2017
Active Locations (11)
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1
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
2
GSK Investigational Site
Duarte, California, United States, 91010
3
GSK Investigational Site
San Francisco, California, United States, 94143
4
GSK Investigational Site
Boston, Massachusetts, United States, 02115