Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals Herpes Zoster subunit vaccine · 2 trials · 1 indication
Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.
Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.
Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] . Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
| Arm | Type | Description |
|---|---|---|
| GSK1437173A Group | EXPERIMENTAL | Subjects ≥ 50 years of age who will receive two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study. |
| Control Group | ACTIVE_COMPARATOR | Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) | BIOLOGICAL | 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm on a 2 month schedule. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the questionnaires and diary cards). * Written informed consent obtained from the subject prior to performance of any study specific procedure. * A ...
GSK Biologicals Herpes Zoster subunit vaccine is an investigational vaccine developed by GSK plc for the prevention of herpes zoster, also known as shingles. It is a subunit vaccine candidate identified as GSK1437173A and is being studied in adults aged 50 years and older.
GSK Biologicals Herpes Zoster subunit vaccine is being developed for the prevention of herpes zoster in adults. Clinical studies have enrolled participants aged 50 years and older, including adults 65 years and older, to evaluate the vaccine candidate in this indication.
GSK Biologicals Herpes Zoster subunit vaccine is being developed by GSK plc, which trades under the ticker GSK. The vaccine candidate is also referred to as GSK1437173A in company and clinical documentation.
GSK Biologicals Herpes Zoster subunit vaccine is in Phase 3 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA. Two Phase 3 trials of the vaccine have been completed, with no active trials currently listed.
GSK Biologicals Herpes Zoster subunit vaccine has been studied in two completed Phase 3 trials. NCT02979639 evaluated the impact of reactogenicity on quality of life in adults 50 years and older, and NCT02581410 assessed immunogenicity and safety in adults 65 years and older with and without prior Zostavax vaccination.
Yes, GSK Biologicals Herpes Zoster subunit vaccine is also known as GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine and by the identifier GSK1437173A. These names refer to the same investigational vaccine candidate developed by GSK plc for herpes zoster.