Month 30 & 42 Extension Studies of CRD-004 Primary Study

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Herpes Zoster

Treatments

Procedure: Blood sampling for assay of persistence of immunogenicity

Study type

Interventional

Funder types

Industry

Identifiers

NCT00492648

109674

109671

Details and patient eligibility

About

The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives & outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.

Full description

All subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine GSK1437173A. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Further details on the primary study can be found on our GSK study register (https://www.gsk-studyregister.com/advanced-search) by searching on the GSK study identifier 101501.

Enrollment

34 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study;
Written informed consent obtained from the subject;
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period;
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed;
Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure;
Previous vaccination against HZ, except the study vaccine administered in the primary study;
History of HZ (shingles);
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination;
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.