Spots Global Cancer Trial Database for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy
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Trial Identification
Brief Title: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy
Official Title: An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 18 Years of Age or Older With Solid Tumours Receiving Chemotherapy
Study ID: NCT01798056
Study Description
Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.
Detailed Description: The study will be randomised into two groups based on the vaccination schedule in relation to the start of a chemotherapy cycle: * The OnChemo group receives their first HZ/su vaccination at the start of a chemotherapy cycle, * The PreChemo group receives their first HZ/su vaccination at least 10 days before the start of a chemotherapy cycle. The protocol summary has been updated following Protocol Amendment 2, August 2014, leading to the increase of the enrolment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GSK Investigational Site, Halifax, Nova Scotia, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Praha 8, , Czechia
GSK Investigational Site, Besançon cedex, , France
GSK Investigational Site, Ferolles-Attilly, , France
GSK Investigational Site, Lyon Cedex 08, , France
GSK Investigational Site, Nîmes cedex 9, , France
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Badajoz, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Majadahonda (Madrid), , Spain
GSK Investigational Site, Móstoles, , Spain
GSK Investigational Site, Pozuelo De Alarcón/Madrid, , Spain
GSK Investigational Site, San Sebastian de los Reyes, , Spain
GSK Investigational Site, Cheltenham, Gloucestershire, United Kingdom
GSK Investigational Site, Woolwich, London, United Kingdom
GSK Investigational Site, Swindon, Wiltshire, United Kingdom
GSK Investigational Site, Exeter, , United Kingdom
GSK Investigational Site, Sheffield, , United Kingdom
GSK Investigational Site, York, , United Kingdom
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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