Study to evaluate efficacy, safety and immunogenicity of GSK Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A in adults aged 50 years and older
Trial overview
Number of subjects with confirmed Herpes zoster (HZ) cases
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with any episodes of Post-Herpetic Neuralgia (PHN)
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with a reduction of duration of severe ‘worst’ HZ-associated pain
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with confirmed HZ episode related mortality
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with HZ related complications
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with confirmed HZ episode related hospitalizations
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with a confirmed HZ episode having a reduction of duration of pain medication associated with HZ
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with a confirmed HZ episode taking pain medication associated with HZ
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of days with severe ‘worst’ HZ-associated pain.
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with confirmed HZ episode related mortality and hospitalizations
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with HZ related complications, by complication type
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Distribution of pain medication associated with HZ
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of days of pain medication associated with HZ
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: Within the 7-day (Days 0-6) post-vaccination period
Number of subjects with any and Grade 3 symptoms (solicited and unsolicited)
Timeframe: Within the 7-day (Days 0-6) post-vaccination period
Number of subjects with any and related potential Immune mediated diseases (pIMDs)
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with AEs with any and related medically attended visit
Timeframe: From Month 0 to Month 8 post-vaccination
Number of subjects with unsolicited adverse events (AEs)
Timeframe: Within 30 days (Days 0 - 29) after each vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)
Number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with fatal SAEs
Timeframe: During the entire study period (3 to 5 years following day 0)
- Subjects who the investigator believes will comply with the requirements of the protocol;
 - Written informed consent obtained from the subject;
 
- 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;
 - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product;
 
- Written informed consent obtained from the subject;
 - A male or female aged 50 years or older at the time of the first vaccination;
 - 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, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;
 
Subjects who the investigator believes will comply with the requirements of the protocol;
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product;
 - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
 - History of HZ;
 - Previous vaccination against varicella or HZ;
 - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation;
 - Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study;
 - Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period;
 - Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine;
 - Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
 - Acute disease and/or fever at the time of enrollment;
 - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
 - Pregnant or lactating female;
 - Female planning to become pregnant or planning to discontinue contraceptive precautions.
 
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;
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.