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.

Phase 2

Completed

• Conditions: herpes zoster; shingles; 10047438; 10040785

• Registration Number: NL-OMON36034
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

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.

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: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4<br /><br>T cells at Months 48, 60 and 72<br /><br><br /><br>2) Antigen-specific Antibody (Ab) concentrations at Months 48, 60 and 72</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Occurrence of Serious Adverse events (SAEs)<br /><br><br /><br>2) Occurrence of pre-defined Adverse events (AEs), i.e. herpes zoster episodes<br /><br>and Potential Immune-Mediated Diseases (pIMDs)<br /><br>* </p><br>