A phase III, randomised, open-label, multicentre, clinical trial to assess the safety and immunogenicity of GSK Biologicals’ HZ/su vaccine when administered intramuscularly according to a 0,2-month schedule, a 0,6-month schedule or a 0,12-month schedule in adults aged 50 years or older. - ZOSTER-026

GlaxoSmithKline Biologicals0 sites354 target enrollmentNovember 12, 2012

ConditionsVaccination against HZ and its related complications in adults older than 50 years MedDRA version: 14.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vaccination against HZ and its related complications in adults older than 50 years
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 354
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 12, 2012

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•\- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•\- A male or female aged 50 years or older at the time of the first vaccination.
•\- Written informed consent obtained from the subject.
•\- Female subjects of non\-childbearing potential may be enrolled in the study.
•\*Non\-childbearing potential is defined as pre\-menarche, current tubal ligation, hysterectomy, ovariectomy or post\-menopause.
•\- Female subjects of childbearing potential may be enrolled in the study, if the subject:
•\*has practiced adequate contraception for 30 days prior to vaccination, and
•\*has a negative pregnancy test on the day of vaccination, and
•\*has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.
•Are the trial subjects under 18? no

Exclusion Criteria

•\- Use of any investigational or non\-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•\- Chronic administration of immunosuppressants or other immune\-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of \< 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra\-articular corticosteroids are allowed.
•\- Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine.
•\- Administration or planned administration of a non\-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine.
•\- Administration of long\-acting immune\-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
•\- Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study).
•\- Planned administration during the study of an HZ or varicella vaccine (including an investigational or non\-registered vaccine) other than the study vaccine.
•\- History of HZ.
•\- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•\- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, human immunodeficiency virus \[HIV] infection) or immunosuppressive/cytotoxic therapy (e.g. medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).