NCT01798056

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Herpes Zoster
• Herpes Zoster Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	GSK 1437173A	2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
DRUG	Placebo	2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.

Timeline

• Start date: 2013-03-06
• Primary completion: 2015-06-18
• Completion: 2016-05-20
• First posted: 2013-02-25
• Last updated: 2021-05-13
• Results posted: 2018-08-17

Locations

28 sites across 6 countries: Canada, Czechia, France, South Korea, Spain, United Kingdom