NCT01295320

Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity. This long term follow up study (ZOSTER-024 \[114825\]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72. The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
PROCEDURE	Blood sample	Blood sample will be collected at Month 48, Month 60 and Month 72

Timeline

• Start date: 2011-02-28
• Primary completion: 2013-06-20
• Completion: 2013-06-20
• First posted: 2011-02-14
• Last updated: 2017-11-27
• Results posted: 2017-10-05

Locations

11 sites across 4 countries: Czechia, Germany, Netherlands, Sweden