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

NCT01295320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2017-11-27

Study results available
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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

PROCEDURE

Blood sample

Blood sample will be collected at Month 48, Month 60 and Month 72

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-06-20
Completion
2013-06-20

Countries

  • Czechia
  • Germany
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01295320 on ClinicalTrials.gov