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)
- Conditions
- Primary immunization of healthy elderly subjects (60 to 69 and more than or equal to 70 years) against zoster
- Registration Number
- EUCTR2006-004863-69-CZ
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 715
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
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
11/ Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period
12/ History of or current drug and/or alcohol abuse.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method