An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals’ candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older. - ZOSTER-024

• Conditions: Evaluation of persistence of immune responses following immunisation of healthy elderly subjects (60-69 and =70 years) against Herpes Zoster (HZ); MedDRA version: 15.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2010-022248-19-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-20
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

1)Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. return for follow-up visits)
2)Previous participation in study ZOSTER-003 as a member of the 50µg gE/AS01B vaccine group;
3)Written informed consent obtained from the subject.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Having participated in another study at any time after ZOSTER-003 study end in which the subject was exposed to an investigational or non-investigational product (pharmaceutical product or device) or; concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device);
2)Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw;
3)Having received a vaccine containing 3-O-desacyl-4’-Monophosphoryl Lipid A (MPL) and/or Quillaja saponaria Molina, fraction 21 (QS21), any time after ZOSTER-003 study end;
4)Having received a vaccine against HZ any time after ZOSTER-003 study end;
5)Subject who did not receive a complete vaccination course of 2 doses of 50µg gE/AS01B in study ZOSTER-003;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified