Study to evaluate efficacy, safety, and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster vaccine GSK1437173A
Trial overview
Number of subjects with confirmed Herpes Zoster (HZ) episode
Timeframe: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
Duration of ‘worst’ HZ-associated pain
Timeframe: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period
Number of subjects with confirmed HZ-associated complications
Timeframe: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
Number of subjects with Postherpetic Neuralgia (PHN)
Timeframe: From Month 0 until study end (21 months median follow-up)
Antigen-glycoprotein E (gE) antibody concentrations in a sub-cohort of subjects
Timeframe: At Months 0, 1, 2, 13 and 25
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: During the 30-day (Days 0-29) post-vaccination period
Number of subjects with any and related potential Immune Mediated Diseases (pIMDs)
Timeframe: From Month 0 up to 365 days post last vaccination
Number of subjects with any relapse
Timeframe: From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
Number of subjects with any Serious Adverse Events (SAEs) and Related SAEs to GSK study vaccine/placebo
Timeframe: From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
Number of subjects with fatal SAEs and SAEs related to study participation or to a GSK concomitant medication or vaccination
Timeframe: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years)
Participation 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.
- 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.
- 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).
Study entry (enrollment) occurs at the Pre-vaccination visit.
- 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).
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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.