A phase II, observer-blind, randomised, placebo-controlled, adjuvant-dose selection, multicenter prophylactic vaccination study to evaluate the immunogenicity and safety of GSK Biologicals’ herpes zoster vaccine, gE/AS01B, in comparison to gE combined with ½ dose AS01B adjuvant (gE/AS01E), to unadjuvanted gE (gE/Saline), and to Saline (placebo) when administered twice in subjects aged 50 years and older. - Zoster-010

GlaxoSmithKline Biologicals0 sites396 target enrollmentStarted: October 21, 2008Last updated: April 3, 2017

Conditions

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 396

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•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 (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study;
•If the subject is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, 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.
•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

•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. (For corticosteroids, this will mean prednisone, or equivalent, more than 0.5 mg/kg/day. Inhaled and topical steroids are allowed);
•Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunisation products [e.g., tetanus and reduced dose diphtheria toxoid (dT) vaccine, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), 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 (e.g., malignancy, HIV-infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders);
•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. (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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral, tympanic or axillary temperature < 37.5°C/99.5°F);
•Any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) 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).

Investigators

Sponsor

GlaxoSmithKline Biologicals

Similar Trials

Active, not recruiting

Phase 1

A study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ investigational vaccine GSK2838504A when administered to patients with persistent airflow obstructio

EUCTR2013-003062-13-GBGlaxoSmithKline Biologicals145

Active, not recruiting

Phase 1

A study to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ investigational vaccine GSK2838504A when administered to chronic obstructive pulmonary disease (COPD) patients with persistent airflow obstructioCOPDMedDRA version: 17.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855MedDRA version: 17.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855

EUCTR2013-003062-13-SEGlaxoSmithKline Biologicals140

Active, not recruiting

Phase 1

Study of safety, reactogenicity and immunogenicity of GlaxoSmithKline’s (GSK)Respiratory Syncytial Virus (RSV)maternal unadjuvanted vaccine in healthy pregnant women (aged 18 to 40 years) and their infants.Healthy Volunteers (prevention of lower respiratory tract illness)

EUCTR2019-001991-12-FIGlaxoSmithKline Biologicals300

Active, not recruiting

Phase 1

EUCTR2019-001991-12-ESGlaxoSmithKline S.A.534

Active, not recruiting

Phase 1

EUCTR2019-001991-12-GBGlaxoSmithKline Biologicals300