Overview

This trial is active, not recruiting.

Condition herpes zoster
Treatments herpes zoster vaccine gsk1437173a, placebo
Phase phase 3
Sponsor GlaxoSmithKline
Start date July 2012
End date November 2016
Trial size 1846 participants
Trial identifier NCT01610414, 115523, 2012-000138-20

Summary

The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Subjects will receive the candidate HZ vaccine GSK 1437173A
herpes zoster vaccine gsk1437173a
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm
(Placebo Comparator)
Subjects will receive the placebo
placebo
2 doses administered IM in deltoid region of non-dominant arm

Primary Outcomes

Measure
Occurrence of confirmed HZ cases
time frame: From Month 0 until study end (4 years approximately)

Secondary Outcomes

Measure
Duration of 'worst' HZ-associated pain
time frame: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period
Occurrence of confirmed HZ-associated complications
time frame: From Month 0 up until study end (4 years approximately)
Occurrence of Postherpetic Neuralgia (PHN)
time frame: From Month 0 until study end (4 years approximately)
Antigen-specific Antibody (Ab) concentrations in a sub-cohort of subjects
time frame: At Month 0, Month 1, Month 2, Month 13 and Month 25
Occurrence of solicited local and general symptoms
time frame: Within 7 days (Days 0-6) after each vaccination
Occurrence of unsolicited adverse events (AEs)
time frame: During 30 days (Days 0-29) after each vaccination
Occurrence of Serious Adverse Events (SAEs)
time frame: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (4 years approximately)
Occurrence of AEs of specific interest
time frame: From Month 0 until study end (4 years, approximately)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Study entry (enrollment) occurs at the Pre-vaccination visit. - Subjects who the investigator believes can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject. - A male or female aged 18 years or older at the time of study entry. - Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs. - Female subjects of non-childbearing potential may be enrolled in the study. For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, 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 12 months after completion of the vaccination series (i.e., until Month 13). 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/placebo, or planned use during the study period. However, the investigational use of a registered or non-registered product to treat the subject's underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed. - Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo. - Planned administration during the study of a HZ vaccine other than the study vaccine. - Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment. - Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV) expected to last more than 6 months after transplantation. - Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo. - HIV infection by clinical history. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).

Additional Information

Official title Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.