A phase II, single-blind, randomized, controlled, multicentre vaccination study to evaluate the safety and immune response of the GSK Biologicals Zoster vaccine, gE/AS01B, and to compare 3 doses of gE with AS01B adjuvant in healthy elderly subjects, aged 60 to 69 years and 70 years and above. - Zoster-003, Zoster-011 (EXT-003 Y1), Zoster-012 (EXT-003 Y2), Zoster-013 (EXT-003 Y3)

GlaxoSmithKline Biologicals0 sites715 target enrollmentNovember 9, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 715
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 9, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•1/ Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow\-up visits) should be enrolled in the study
•2/ A male or female aged 60 years or older at the time of the first vaccination
•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/ Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period
•2/ Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within three months prior to the first vaccination, including corticosteroids, except inhaled and topical steroids are allowed.)
•3/ Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection
•4/ Previous administration of a vaccine containing MPL and/or QS21
•5/ Previous vaccination against HZ
•6/ History of herpes zoster (Shingles)
•7/ Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
•8/ History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
•9/ Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low\-grade febrile illness, i.e., Oral temperature \<37\.5°C (99\.5°F)/Axillary temperature \<37\.5°C (99\.5°F)
•10/ Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject’s medical history or physical examination as assessed by the investigator