Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
Completed · Phase 2 · Has a placebo group
Conditions studied: Herpes Zoster
In brief
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 safety profiles of the different formulations.
Key facts
- Study ID
- NCT00802464
- Run by
- GlaxoSmithKline
- People needed
- 410
- Starts
- 2009-01-12
- Expected to finish
- 2010-07-02
- Last updated by the study team
- 2019-06-26
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- GSK Investigational Site — Phoenix, Arizona, United States
- GSK Investigational Site — Pembroke Pines, Florida, United States
- GSK Investigational Site — Las Vegas, Nevada, United States
- GSK Investigational Site — Edison, New Jersey, United States
- GSK Investigational Site — Raleigh, North Carolina, United States
- GSK Investigational Site — Cleveland, Ohio, United States
- GSK Investigational Site — Pittsburgh, Pennsylvania, United States
- GSK Investigational Site — Hradec Králové, Czechia
- GSK Investigational Site — Barcelona, Spain
- GSK Investigational Site — Barcelona, Spain
- GSK Investigational Site — Mahadahonda( Madrid, Spain
- GSK Investigational Site — Marid, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.