Status:
COMPLETED
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Zoster
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the ...
Eligibility Criteria
Inclusion
- A male or female 50 years of age or above at the time of the first vaccination;
- Written informed consent obtained from the subject;
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
- Previous vaccination against HZ;
- Previous vaccination against varicella;
- History of HZ;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
- 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;
- Acute disease at the time of enrolment.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
- History of or current drug and/or alcohol abuse;
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.
Key Trial Info
Start Date :
January 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2010
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00802464
Start Date
January 12 2009
End Date
July 2 2010
Last Update
June 26 2019
Active Locations (12)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85020
2
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
3
GSK Investigational Site
Las Vegas, Nevada, United States, 89130
4
GSK Investigational Site
Edison, New Jersey, United States, 08817